Category: Cosmetic Advisories

FDA Advisory No. 2020-592-A || Lifting the Advisory on the Notified Cosmetic Product “CARELINE LIP BALM APPLE” under FDA Advisory No. 2020-592 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic CARELINE LIP BALM APPLE” Dated 08 April 2020

The Food and Drug Administration (FDA) informs the public that the Cosmetic product Careline Lip Balm with Notificaition No. 1000001375452, has been notified by the Market Authorization Holder, EVER BILENA COSMETICS, INC. in accordance with existing FDA rules and regulations.

Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No. 2020-592 and FDA Order No. 2020-365 is hereby lifted.

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 health product before purchasing. For more information or inquiries, please email us at [email protected], you may also call the Center for Cosmetics Regulation and Research at telephone number (02) 8857-1900 loc. 8113 or 8107.

To report the sale or distribution of any unnotified/unregistered health products, kindly email FDA via [email protected].

Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-592-A

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-592-A || Lifting the Advisory on the Notified Cosmetic Product “CARELINE LIP BALM APPLE” under FDA Advisory No. 2020-592 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic CARELINE LIP BALM APPLE” Dated 08 April 2020

FDA Advisory No. 2020-1201 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product “IVY BEAUTY COLLAGEN LIP PLUMPER COLLAGEN LIP BALM LEMON”

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, “IVY BEAUTY COLLAGEN LIP PLUMPER COLLAGEN LIP BALM LEMON” with details specified below:

PRODUCT PARTICULARS
Local Company Responsible for Placing the Product in the Market: A&W Marketing Philippines

Address: N/I

Country of Manufacture: China

Lot/Batch Number: 111A031401

Manufacturing Date: N/I

Expiration Date: 20191110

NON-COMPLIANCE/S
The ingredients listed on the label is inconsistent with the information declared in the acknowledged Product Notification.

The Food and Drug Administration has verified that the abovementioned product is NON-COMPLIANT through its postmarketing surveillance (PMS) pursuant to Book I, Article II, Section 2 of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009” which provides for the relevant functions, powers and duties of the agency, including the conduct of PMS activities in the monitoring of health products.

Based on the Certificate of Product Notification issued to the company, any subsequent changes to the information previously submitted to the FDA will render the notification invalid, thus, a new notification will have to be submitted.

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

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1201

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1201 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product “IVY BEAUTY COLLAGEN LIP PLUMPER COLLAGEN LIP BALM LEMON”

FDA Advisory No. 2020-1200 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product “UNO SWAK BABY WIPES”

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, “UNO SWAK BABY WIPES “ with details specified below:

PRODUCT PARTICULARS
Local Company Responsible for Placing the Product in the Market: Not Indicated

Address: Not Indicated

Country of Manufacture: Not Indicated

Lot/Batch Number: Not Indicated

Manufacturing Date: 02/2019

Expiration Date: 02/2022

NON-COMPLIANCE/S
1. The ingredients listed on the label (PROPYLENE GLYCOL, PHENOXYETHANOL, CHAMOMILLA RECUTITA (MATRICARIA FLOWER EXTRACT), BENZOIC ACID, DEHYDROACETIC ACID, SODIUM CITRATE, PARFUM) is inconsistent with the information declared in the acknowledged notification renders the product unnotified.

2. Failure to declare the name and address of the local company responsible, the Country of Manufacture and the Batch Number on the label.”

The Food and Drug Administration has verified that the abovementioned product is NON-COMPLIANT through its postmarketing surveillance (PMS) pursuant to Book I, Article II, Section 2 of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009” which provides for the relevant functions, powers and duties of the agency, including the conduct of PMS activities in the monitoring of health products.

Based on the Certificate of Product Notification issued to the company, any subsequent changes to the information previously submitted to the FDA will render the notification invalid, thus, a new notification will have to be submitted.

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

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1200

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1200 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product “UNO SWAK BABY WIPES”

FDA Advisory No. 2020-1196 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product “QUICK FX CC CREAM”

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, “QUICK FX CC CREAM” with details specified below:

PRODUCT PARTICULARS
Local Company Responsible for Placing the Product in the Market: DESCORP INC.

Address: DJMA Commercial Center, Abel Nosce St., BFRV, Las Piñas City

Country of Manufacture: Korea, Republic of

Lot/Batch Number: HAA20180129

Manufacturing Date: N/I

Expiration Date: 20200128

NON-COMPLIANCE/S
The ingredients listed on the label are inconsistent with the information declared in the acknowledged Product Notification.

The Food and Drug Administration has verified that the abovementioned product is NON-COMPLIANT through its postmarketing surveillance (PMS) pursuant to Book I, Article II, Section 2 of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009” which provides for the relevant functions, powers and duties of the agency, including the conduct of PMS activities in the monitoring of health products.

Based on the Certificate of Product Notification issued to the company, any subsequent changes to the information previously submitted to the FDA will render the notification invalid, thus, a new notification will have to be submitted.

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

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1196

FDA Advisory No. 2020-1195 || and Use of the Non-Compliant Cosmetic Product “HUMMING PLUS THE SKIN BREATHE GREEN TEA PEELING GEL FACE SCRUB”

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, “HUMMING PLUS THE SKIN BREATHE GREEN TEA PEELING GEL FACE SCRUB” with details specified below:

PRODUCT PARTICULARS
Local Company Responsible for Placing the Product in the Market:

Hummingplus Phils. Inc

Address: #1 Aduana St., New Intramuros Village, Brgy. Old Balara, Quezon City, 1119, Philippines

Country of Manufacture: Korea, Republic of

Lot/Batch Number: Not Indicated

Manufacturing Date: Not Indicated

Expiration Date: EXP 05MAR2019

NON-COMPLIANCE/S
1. The ingredients listed on the label are inconsistent with the information declared in the acknowledged product notification.
2. Failure to declare the batch number on the label.

The Food and Drug Administration has verified that the abovementioned product is NON-COMPLIANT through its postmarketing surveillance (PMS) pursuant to Book I, Article II, Section 2 of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009” which provides for the relevant functions, powers and duties of the agency, including the conduct of PMS activities in the monitoring of health products.

Based on the Certificate of Product Notification issued to the company, any subsequent changes to the information previously submitted to the FDA will render the notification invalid, thus, a new notification will have to be submitted.

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

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1195

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1195 || and Use of the Non-Compliant Cosmetic Product “HUMMING PLUS THE SKIN BREATHE GREEN TEA PEELING GEL FACE SCRUB”

FDA Advisory No. 2020-1186 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product “LIGHTNESS ORGANIC HAIR SERUM HERBAL FORMULA”

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, “LIGHTNESS ORGANIC HAIR SERUM HERBAL FORMULA” with details specified below:

PRODUCT PARTICULARS
Local Company Responsible for Placing the Product in the Market: XU RI TRADING CORP.

Address: 525 Lavezares St. San Nicolas, Manila

Country of Manufacture: China

Lot/Batch Number: LI5111BN20180528

Manufacturing Date: MFG 05/2018

Expiration Date: EXP 04/2021

NON-COMPLIANCE/S
The ingredients listed on the label are inconsistent with the information declared in the acknowledged Product Notification.

The Food and Drug Administration has verified that the abovementioned product is NON-COMPLIANT through its postmarketing surveillance (PMS) pursuant to Book I, Article II, Section 2 of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009” which provides for the relevant functions, powers and duties of the agency, including the conduct of PMS activities in the monitoring of health products.

Based on the Certificate of Product Notification issued to the company, any subsequent changes to the information previously submitted to the FDA will render the notification invalid, thus, a new notification will have to be submitted.

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

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1186

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1186 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product “LIGHTNESS ORGANIC HAIR SERUM HERBAL FORMULA”

FDA Advisory No. 2020-1176 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product “3W CLINIC INTENSIVE UV SUNBLOCK CREAM”

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, “3W CLINIC INTENSIVE UV SUNBLOCK CREAM” with details specified below:

PRODUCT PARTICULARS
Local Company Responsible for Placing the Product in the Market: BROSNEP

Address: 99 Ramon Magsaysay Ave., Guadalupe, Makati

Country of Manufacture: Korea, Democratic People’s Republic of

Lot/Batch Number: Not Indicated

Manufacturing Date: 20180807

Expiration Date: 20210806

NON-COMPLIANCE/S
The ingredients listed on the label are inconsistent with the information declared in the acknowledged product notification.

The Food and Drug Administration has verified that the abovementioned product is NON-COMPLIANT through its postmarketing surveillance (PMS) pursuant to Book I, Article II, Section 2 of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009” which provides for the relevant functions, powers and duties of the agency, including the conduct of PMS activities in the monitoring of health products.

Based on the Certificate of Product Notification issued to the company, any subsequent changes to the information previously submitted to the FDA will render the notification invalid, thus, a new notification will have to be submitted.

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

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1176

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1176 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product “3W CLINIC INTENSIVE UV SUNBLOCK CREAM”

FDA Advisory No. 2020-1215 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic HUDABEAUTY MIRROR NAIL POLISH

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

  1. HUDABEAUTY MIRROR NAIL POLISH

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 17 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1215

FDA Advisory No. 2020-1214 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic LITTLE TWIG® BUBBLE BATH HAPPY TANGERINE

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

  1. LITTLE TWIG® BUBBLE BATH HAPPY TANGERINE

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 17 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1214

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1214 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic LITTLE TWIG® BUBBLE BATH HAPPY TANGERINE

FDA Advisory No. 2020-1213 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic DODO GIRL PROFESSIONAL MAKEUP DON’T BE SHY! I’M BLUSHER

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

  1. DODO GIRL PROFESSIONAL MAKEUP DON’T BE SHY! I’M BLUSHER

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 17 June 2020. 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1213

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1213 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic DODO GIRL PROFESSIONAL MAKEUP DON’T BE SHY! I’M BLUSHER

FDA Advisory No. 2020-1212 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic PERFUME SPRAY PASSY WONDER NATURAL SPRAY

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

  1. PERFUME SPRAY PASSY WONDER NATURAL SPRAY

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 17 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1212

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1212 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic PERFUME SPRAY PASSY WONDER NATURAL SPRAY

FDA Advisory No. 2020-1211 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic GORGEOUS AUTHORITY (VERY BERRY / YUMMY ORANGE)

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

  1. GORGEOUS AUTHORITY (VERY BERRY / YUMMY ORANGE)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 17 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1211

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1211 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic GORGEOUS AUTHORITY (VERY BERRY / YUMMY ORANGE)

FDA Advisory No. 2020-1210 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic MINISTAR NATURAL CARE BLACK MASK DEEP CLEANSING WHITENING COMPLEX

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

  1. MINISTAR NATURAL CARE BLACK MASK DEEP CLEANSING WHITENING COMPLEX

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 17 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1210

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1210 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic MINISTAR NATURAL CARE BLACK MASK DEEP CLEANSING WHITENING COMPLEX

FDA Advisory No. 2020-1209 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ULTRA HYDRATING ESSENCE MASK GREEN TEA

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

  1. ULTRA HYDRATING ESSENCE MASK GREEN TEA

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 17 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1209

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1209 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ULTRA HYDRATING ESSENCE MASK GREEN TEA

FDA Advisory No. 2020-1208 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic XIMIVOGUE LILY FRAGRANCE BODY LOTION

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

  1. XIMIVOGUE LILY FRAGRANCE BODY LOTION

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 17 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1208

FDA Advisory No. 2020-1207 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic 3CE SASIMI MATTE 05

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

  1. 3CE SASIMI MATTE 05

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 17 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1207

FDA Advisory No. 2020-1206 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic LUCA BOSSI CAMEE EAU DE PARFUM NATURAL SPRAY

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

  1. LUCA BOSSI CAMEE EAU DE PARFUM NATURAL SPRAY

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 17 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1206

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1206 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic LUCA BOSSI CAMEE EAU DE PARFUM NATURAL SPRAY

FDA Advisory No. 2020-1199 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic MINISO MISS MODERN PERFUME

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

  1. MINISO MISS MODERN PERFUME

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 15 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1199

FDA Advisory No. 2020-1198 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product “DERMAX PROFESSIONAL NANOWHITE UNDERARM CREAM”

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, “DERMAX PROFESSIONAL NANOWHITE UNDERARM CREAM” with details specified below:

PRODUCT PARTICULARS
Local Company Responsible for Placing the Product in the Market: My Sanctuary Wellness Center Inc.

Address: Executive Bldg., 369 Gil Puyat Ave., Makati City, Philippines

Country of Manufacture: Not Indicated

Lot/Batch Number: 1807MSWCUAC136

Manufacturing Date: 07.02.18

Expiration Date: 07.02.21

NON-COMPLIANCE/S
The ingredients listed on the label are inconsistent with the information declared in the acknowledged Product Notification.

The Food and Drug Administration has verified that the abovementioned product is NON-COMPLIANT through its postmarketing surveillance (PMS) pursuant to Book I, Article II, Section 2 of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009” which provides for the relevant functions, powers and duties of the agency, including the conduct of PMS activities in the monitoring of health products.

Based on the Certificate of Product Notification issued to the company, any subsequent changes to the information previously submitted to the FDA will render the notification invalid, thus, a new notification will have to be submitted.

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

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1198

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1198 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product “DERMAX PROFESSIONAL NANOWHITE UNDERARM CREAM”

FDA Advisory No. 2020-1197 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product “FASH FOAM FACE WASH”

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, “FASH FOAM FACE WASH” with details specified below:

PRODUCT PARTICULARS
Local Company Responsible for Placing the Product in the Market: CURATIO INC.

Address: Unit 2114 Cityland 10 Tower 2, 154 H.V. Dela Costa St., Brgy. Bel-Air, Makati City

Country of Manufacture: India

Lot/Batch Number: FF1901

Manufacturing Date: 04/2019

Expiration Date: 03/2021

NON-COMPLIANCE/S
The ingredients listed on the label is inconsistent with the information declared in the acknowledged Product Notification.

The Food and Drug Administration has verified that the abovementioned product is NON-COMPLIANT through its postmarketing surveillance (PMS) pursuant to Book I, Article II, Section 2 of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009” which provides for the relevant functions, powers and duties of the agency, including the conduct of PMS activities in the monitoring of health products.

Based on the Certificate of Product Notification issued to the company, any subsequent changes to the information previously submitted to the FDA will render the notification invalid, thus, a new notification will have to be submitted.

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

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1197

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1197 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product “FASH FOAM FACE WASH”

FDA Advisory No. 2020-1194 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic AS ASHLEY SHINE LIPSTICK LOVER MOISTURIZING LIPSTICK (20)

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

  1. AS ASHLEY SHINE LIPSTICK LOVER MOISTURIZING LIPSTICK (20)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1194

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1194 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic AS ASHLEY SHINE LIPSTICK LOVER MOISTURIZING LIPSTICK (20)

FDA Advisory No. 2020-1126 || Public Health Warning Against the Purchase and Use of Cosmetic Product BEAUCHE CLARIFYING SOLUTION Containing Banned Ingredient/s

The Food and Drug Administration (FDA) warns the public from purchasing and using the adulterated cosmetic product BEAUCHE CLARIFYING SOLUTION which tested positive for the presence of HYDROQUINONE and TRETINOIN. Such ingredients are not allowed to be part of a cosmetic product as per Annex 1.1 Part 1 of the ASEAN Cosmetic Directive. As per Administrative Order No. 13 s. 1999, products containing Hydroquinone and/or Tretinoin (Retinoic Acid) are classified as home remedy, over-the-counter, or prescription drug. The table below indicates the particulars of the adulterated cosmetic product/s:

PRODUCT DETAILS
Name of Manufacturer/ Local Company Responsible for Placing the Product in the Market:

Beauche International by Conchita, Inc. 

Address:

Blk 6 Lot 9-11, Dasmariñas Technopark, Brgy. Paliparan I, Dasmariñas City, Cavite, Philippines 4114

Country of Manufacture:

Philippines

Lot/Batch Number: 7209193025

Mfg. Date: 25 JUL 2019

Exp. Date: 25 JUL 2021

The aforementioned adulterated product is found to be non-compliant with the existing standards, and, thus pose potential hazards to the consuming public. The use of 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 adulterated cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (ww2.fda.gov.ph.). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute adulterated cosmetic products.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative cosmetic product, the online reporting facility, eReport can be accessed 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.2020-1126

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1126 || Public Health Warning Against the Purchase and Use of Cosmetic Product BEAUCHE CLARIFYING SOLUTION Containing Banned Ingredient/s

FDA Advisory No. 2020-1193 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic MUMUSO HONEY MILK DEEP NOURISHING LIP CARE SET

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product MUMUSO HONEY MILK DEEP NOURISHING LIP CARE SET:

  1. Mumuso Honey Milk Moisturizing Lip Gel
  2. Mumuso Honey Milk Moisturizing Lip Scrub

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1193

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1193 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic MUMUSO HONEY MILK DEEP NOURISHING LIP CARE SET

FDA Advisory No. 2020-1192 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic HUDABEAUTY WATERPROOF MASCARA

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

  1. HUDABEAUTY WATERPROOF MASCARA

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1192

FDA Advisory No. 2020-1191 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic HAPPY® SKIN INSTA BEAUTY BLUR CREAM PRIMER FOUNDATION

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

  1.  HAPPY® SKIN INSTA BEAUTY BLUR CREAM PRIMER FOUNDATION

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1191

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1191 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic HAPPY® SKIN INSTA BEAUTY BLUR CREAM PRIMER FOUNDATION

FDA Advisory No. 2020-1190 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic NOVO TINT LIPBAR (08# DOUBLE COLOR) NO.5170

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

  1. NOVO TINT LIPBAR (08# DOUBLE COLOR) NO.5170

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1190

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1190 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic NOVO TINT LIPBAR (08# DOUBLE COLOR) NO.5170

FDA Advisory No. 2020-1189 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic L & F LAUFERS FLAT FINISH PIGMENT GLOSS MATTE

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

  1. L & F LAUFERS FLAT FINISH PIGMENT GLOSS MATTE

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1189

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1189 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic L & F LAUFERS FLAT FINISH PIGMENT GLOSS MATTE

FDA Advisory No. 2020-1188 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic AS ASHLEY SHINE LIPSTICK LOVER MOISTURIZING LIPSTICK (168)

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

  1. AS ASHLEY SHINE LIPSTICK LOVER MOISTURIZING LIPSTICK (168)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1188

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1188 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic AS ASHLEY SHINE LIPSTICK LOVER MOISTURIZING LIPSTICK (168)

FDA Advisory No. 2020-1187 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic VARIANCE® PERMANENT COLOR CREAM (7) COFFEE

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

  1. VARIANCE® PERMANENT COLOR CREAM (7) COFFEE

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1187

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1187 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic VARIANCE® PERMANENT COLOR CREAM (7) COFFEE

FDA Advisory No. 2020-1185 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic MEIS COSMETICS BLUSHER (02)

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

  1. MEIS COSMETICS BLUSHER (02)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 June 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 unauthorized 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 cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative 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.2020-1185

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