Category: Cosmetic Advisories

FDA Advisory No. 2020-944 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic MEIYA EYE SHADOW (ME-5115 05)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. MEIYA EYE SHADOW (ME-5115 05)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-944

FDA Advisory No. 2020-943 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic 3CEYES® CREAMY STEREO REPAIR CAPACITY BAR

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. 3CEYES® CREAMY STEREO REPAIR CAPACITY BAR

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-943

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-943 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic 3CEYES® CREAMY STEREO REPAIR CAPACITY BAR

FDA Advisory No. 2020-942 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic LET’S SAY NO EYE-WRINKLE REMOVAL CRYSTAL MASK NO. BSM-506

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. LET’S SAY NO EYE-WRINKLE REMOVAL CRYSTAL MASK NO. BSM-506

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-942

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-942 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic LET’S SAY NO EYE-WRINKLE REMOVAL CRYSTAL MASK NO. BSM-506

FDA Advisory No. 2020-941 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic ELIZAVECCA MILKY PIGGY 3 STEP BLACK HEAD SOLUTION

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. ELIZAVECCA MILKY PIGGY 3 STEP BLACK HEAD

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-941

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-941 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic ELIZAVECCA MILKY PIGGY 3 STEP BLACK HEAD SOLUTION

FDA Advisory No. 2020-940 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic PUREDERM SNAIL AGE REGENERATING MULTI-STEP TREATMENT (AGE REGENERATING AMPOULE + SNAIL 3D MASK)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. PUREDERM SNAIL AGE REGENERATING MULTI-STEP TREATMENT (AGE REGENERATING AMPOULE + SNAIL 3D MASK)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-940

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-940 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic PUREDERM SNAIL AGE REGENERATING MULTI-STEP TREATMENT (AGE REGENERATING AMPOULE + SNAIL 3D MASK)

FDA Advisory No. 2020-939 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic EYELASH ENHANCER 100% NATURAL

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. EYELASH ENHANCER 100% NATURAL

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-939

FDA Advisory No. 2020-938 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic ONLY ME COLOGNE FOR WOMEN (SWEET DREAMS)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. ONLY ME COLOGNE FOR WOMEN (SWEET DREAMS)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-938

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-938 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic ONLY ME COLOGNE FOR WOMEN (SWEET DREAMS)

FDA Advisory No. 2020-937 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic PROFESSIONAL SKIN CARE FORMULA MELASMA SOAP

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. PROFESSIONAL SKIN CARE FORMULA MELASMA SOAP

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-937

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-937 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic PROFESSIONAL SKIN CARE FORMULA MELASMA SOAP

FDA Advisory No. 2020-936 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic DISNEY ESKULIN KIDS HAND SANITIZER (BLUE) WITH VITAMIN E AND MOISTURIZER

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. DISNEY ESKULIN KIDS HAND SANITIZER (BLUE) WITH VITAMIN E AND MOISTURIZER

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-936

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-936 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic DISNEY ESKULIN KIDS HAND SANITIZER (BLUE) WITH VITAMIN E AND MOISTURIZER

FDA Advisory No. 2020-935 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic SASIMI AQUA BASE HYDRA FACIAL MOUSSE SPF 50++++PA

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. SASIMI AQUA BASE HYDRA FACIAL MOUSSE SPF 50++++PA

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-935

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-935 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic SASIMI AQUA BASE HYDRA FACIAL MOUSSE SPF 50++++PA

FDA Advisory No. 2020-934 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic OSUER’ NEW IMPROVE O MEI SU PEARL CREAM FOR OILY SKIN

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. OSUER’ NEW IMPROVE O MEI SU PEARL CREAM FOR OILY SKIN

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-934

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-934 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic OSUER’ NEW IMPROVE O MEI SU PEARL CREAM FOR OILY SKIN

FDA Advisory No. 2020-933 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic MN® ME NOW WATERPROOF LONGLASTING HIGH QUALITY COSMETIC PENCIL

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. MN® ME NOW WATERPROOF LONGLASTING HIGH QUALITY COSMETIC PENCIL

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-933

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-933 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic MN® ME NOW WATERPROOF LONGLASTING HIGH QUALITY COSMETIC PENCIL

FDA Advisory No. 2020-932 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic COLOR EXPERT SUPER CARE COLOUR CREAM WITH NATURAL COLOR VARIANT: 0.00

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. COLOR EXPERT SUPER CARE COLOUR CREAM WITH NATURAL COLOR VARIANT: 0.00

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-932

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-932 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic COLOR EXPERT SUPER CARE COLOUR CREAM WITH NATURAL COLOR VARIANT: 0.00

FDA Advisory No. 2020-931 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic DAISO MOIST & LIFT GEL

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. DAISO MOIST & LIFT GEL

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-931

FDA Advisory No. 2020-930 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic MINISO HORSE OIL MOISTURIZING LIP BALM

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. MINISO HORSE OIL MOISTURIZING LIP BALM

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 14 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-930

FDA Advisory No. 2020-929 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic KERATIN SMOOTH ARGAN OIL & COLLAGEN COLOR CREAM

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. KERATIN SMOOTH ARGAN OIL & COLLAGEN COLOR CREAM

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 14 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-929

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-929 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic KERATIN SMOOTH ARGAN OIL & COLLAGEN COLOR CREAM

FDA Advisory No. 2020-928 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic EVER BILENA LIQUID FOUNDATION

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. EVER BILENA LIQUID FOUNDATION

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 14 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-928

FDA Advisory No. 2020-927 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic ALODERMA NATURAL ALOE HAIR TONIC

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. ALODERMA NATURAL ALOE HAIR TONIC

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 14 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-927

FDA Advisory No. 2020-926 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic SUN KISSED ORGANIC CLAY BLUSH (ORGANIC)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. SUN KISSED ORGANIC CLAY BLUSH (ORGANIC)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 14 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-926

FDA Advisory No. 2020-925 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic TONY MOLY MINIS

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

  1. TONY MOLY MINIS

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 14 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-925

FDA Advisory No. 2020-924 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Childcare Article (TCCA) STONY ANGEL SILICONE NIPPLE 3-PACK (SIZE M)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified toy and childcare article (TCCA) product:

  1. STONY ANGEL SILICONE NIPPLE 3-PACK (SIZE M)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 14 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified toy and childcare article product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a toy and childcare article product. The use of substandard and possibly adulterated toy and childcare article product may result to health risks including, but not limited to, endocrine disruption and reproductive or development effects; or may result to injury, choking or suffocation due to its small or broken parts.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a toy and childcare article product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative toy and childcare article product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the toy and childcare article product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified toy and childcare articles, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-924

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-924 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Childcare Article (TCCA) STONY ANGEL SILICONE NIPPLE 3-PACK (SIZE M)

FDA Advisory No. 2020-923 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Childcare Article (TCCA) BROTHER MAX TRAVEL SPOONS

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified toy and childcare article (TCCA) product:

  1. BROTHER MAX TRAVEL SPOONS

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified toy and childcare article product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a toy and childcare article product. The use of substandard and possibly adulterated toy and childcare article product may result to health risks including, but not limited to, endocrine disruption and reproductive or development effects; or may result to injury, choking or suffocation due to its small or broken parts.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a toy and childcare article product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative toy and childcare article product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the toy and childcare article product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified toy and childcare articles, email us at e[email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-923

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-923 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Childcare Article (TCCA) BROTHER MAX TRAVEL SPOONS

FDA Advisory No. 2020-922 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Childcare Article (TCCA) STONY ANGEL SILICONE NIPPLE (SIZE S SLOW FLOW)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified toy and childcare article (TCCA) product:

  1. STONY ANGEL SILICONE NIPPLE (SIZE S SLOW FLOW)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no record of valid Certificate of Product Notification (CPN) as of 12 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified toy and childcare article product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a toy and childcare article product. The use of substandard and possibly adulterated toy and childcare article product may result to health risks including, but not limited to, endocrine disruption and reproductive or development effects; or may result to injury, choking or suffocation due to its small or broken parts.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a toy and childcare article product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative toy and childcare article product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the toy and childcare article product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified toy and childcare articles, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-922

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-922 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Childcare Article (TCCA) STONY ANGEL SILICONE NIPPLE (SIZE S SLOW FLOW)

FDA Advisory No. 2020-921 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Childcare Article (TCCA) ANIMAL ASSORTED PLASTIC TOYS

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified toy and childcare article (TCCA) product:

  1. ANIMAL ASSORTED PLASTIC TOYS

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified toy and childcare article product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a toy and childcare article product. The use of substandard and possibly adulterated toy and childcare article product may result to health risks including, but not limited to, endocrine disruption and reproductive or development effects; or may result to injury, choking or suffocation due to its small or broken parts.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a toy and childcare article product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative toy and childcare article product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the toy and childcare article product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified toy and childcare articles, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-921

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-921 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Childcare Article (TCCA) ANIMAL ASSORTED PLASTIC TOYS

FDA Advisory No. 2020-920 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) SIMPLYLIVING PERSONAL REPELLENT MOSQUITO REPELLENT SPRAY SANRIO CHARACTERS

The Food and Drug Administration (FDA) warns the public from purchasing and using the unregistered household/urban pesticide (H/UP) product:

  1. SIMPLYLIVING PERSONAL REPELLENT MOSQUITO REPELLENT SPRAY SANRIO CHARACTERS

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Registration (CPR) as of 14 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unregistered household/urban pesticide product has not gone through the registration process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from harmful, toxic and banned active ingredients that pose imminent danger to human and animal health. The use of substandard and possibly adulterated household/urban pesticide products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock, respiratory disorders, endocrine complications, brain damage and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a household/urban pesticide product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative household/urban pesticides until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Registration (CPR) for the household/urban pesticides.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unregistered household/urban pesticides,  email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-920

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-920 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) SIMPLYLIVING PERSONAL REPELLENT MOSQUITO REPELLENT SPRAY SANRIO CHARACTERS

FDA Advisory No. 2020-919 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) COMBI HERBAL BABY INSECT REPELLENT SPRAY

The Food and Drug Administration (FDA) warns the public from purchasing and using the unregistered household/urban pesticide (H/UP) product:

  1. COMBI HERBAL BABY INSECT REPELLENT SPRAY

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Registration (CPR) as of 14 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unregistered household/urban pesticide product has not gone through the registration process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from harmful, toxic and banned active ingredients that pose imminent danger to human and animal health. The use of substandard and possibly adulterated household/urban pesticide products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock, respiratory disorders, endocrine complications, brain damage and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a household/urban pesticide product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative household/urban pesticides until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Registration (CPR) for the household/urban pesticides.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unregistered household/urban pesticides,  email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-919

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-919 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) COMBI HERBAL BABY INSECT REPELLENT SPRAY

FDA Advisory No. 2020-918 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) CHICCO ANTI-MOSQUITO BABY SPRAY

The Food and Drug Administration (FDA) warns the public from purchasing and using the unregistered household/urban pesticide (H/UP) product:

  1. CHICCO ANTI-MOSQUITO BABY SPRAY

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Registration (CPR) as of 14 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unregistered household/urban pesticide product has not gone through the registration process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from harmful, toxic and banned active ingredients that pose imminent danger to human and animal health. The use of substandard and possibly adulterated household/urban pesticide products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock, respiratory disorders, endocrine complications, brain damage and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a household/urban pesticide product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative household/urban pesticides until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Registration (CPR) for the household/urban pesticides.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unregistered household/urban pesticides,  email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-918

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-918 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) CHICCO ANTI-MOSQUITO BABY SPRAY

FDA Advisory No. 2020-917 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) FUMAKILLA’S RAT KILLER (GRANULAR DORA)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unregistered household/urban pesticide (H/UP) product:

  1. FUMAKILLA’S RAT KILLER (GRANULAR DORA)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Registration (CPR) as of 14 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unregistered household/urban pesticide product has not gone through the registration process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from harmful, toxic and banned active ingredients that pose imminent danger to human and animal health. The use of substandard and possibly adulterated household/urban pesticide products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock, respiratory disorders, endocrine complications, brain damage and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a household/urban pesticide product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative household/urban pesticides until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Registration (CPR) for the household/urban pesticides.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unregistered household/urban pesticides,  email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-917

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-917 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) FUMAKILLA’S RAT KILLER (GRANULAR DORA)

FDA Advisory No. 2020-916 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) RUSH DEER PEARL BALLS (NAPHTHALENE BALLS)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unregistered household/urban pesticide (H/UP) product:

  1. RUSH DEER PEARL BALLS (NAPHTHALENE BALLS)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Registration (CPR) as of 14 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unregistered household/urban pesticide product has not gone through the registration process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from harmful, toxic and banned active ingredients that pose imminent danger to human and animal health. The use of substandard and possibly adulterated household/urban pesticide products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock, respiratory disorders, endocrine complications, brain damage and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a household/urban pesticide product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative household/urban pesticides until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Registration (CPR) for the household/urban pesticides.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unregistered household/urban pesticides,  email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-916

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-916 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) RUSH DEER PEARL BALLS (NAPHTHALENE BALLS)

FDA Advisory No. 2020-915 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic HORTALEZA CALLUS REMOVER

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product,:

  1. HORTALEZA CALLUS REMOVER

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 08 May 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unnotified cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-915

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