Category: Cosmetic Advisories

FDA Advisory No. 2020-704-A || Lifting the Advisory on the Notified Product “CHICCO DENTIFRICIO TOOTHPASTE (MELA-APPLE BANANA)” under FDA Advisory No. 2020-704 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic CHICCO DENTIFRICIO TOOTHPASTE (MELA-APPLE BANANA)” Dated 16 April 2020

The Food and Drug Administration (FDA) informs the public that the Cosmetic product CHICCO DENTIFRICIO TOOTHPASTE (MELA-APPLE BANANA) with Notification No. 1000006556643 has been notified by the Market Authorization Holder, Europlay Distributor Company, 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. 2020-704 and FDA Order No. 2020-445 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 8117.

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.2020-704-A

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-704-A || Lifting the Advisory on the Notified Product “CHICCO DENTIFRICIO TOOTHPASTE (MELA-APPLE BANANA)” under FDA Advisory No. 2020-704 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic CHICCO DENTIFRICIO TOOTHPASTE (MELA-APPLE BANANA)” Dated 16 April 2020

FDA Advisory No. 2020-1104-A || Lifting the Advisory on the Notified Cosmetic Product “MANUKA HEALTHY HONEY 100% NATURAL LIP BALM” under FDA Advisory No. 2020-1104 “Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic Product MANUKA HEALTHY HONEY 100% NATURAL LIP BALM” Dated 16 June 2020

The Food and Drug Administration (FDA) informs the public that the Cosmetic product MANUKA HEALTHY HONEY 100% NATURAL LIP BALM with Notification No. 1000006589658  has been notified by the Market Authorization Holder, Bee Healthy Trading & Distribution 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. 2020-1104 and FDA Order No. 2020-748 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.2020-1104-A

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1104-A || Lifting the Advisory on the Notified Cosmetic Product “MANUKA HEALTHY HONEY 100% NATURAL LIP BALM” under FDA Advisory No. 2020-1104 “Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic Product MANUKA HEALTHY HONEY 100% NATURAL LIP BALM” Dated 16 June 2020

FDA Advisory No. 2020-1757 || Public Health Warning Against the Purchase and Use of the following Non-Compliant Cosmetic Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following non-compliant cosmetic products imported and distributed by the Market Authorization Holder (MAH), Healthy Innovation Distribution Inc.:

1. FRESH SKINLAB 98% TOMATO GLASS SKIN WATER DROP CREAM SPF 30
2. FRESH SKINLAB 98% TOMATO GLASS SKIN SUN GEL SPF 50 PA++++
3. SUNGLOW BY FRESH TINTED LIPSCREEN SPF 50 PA++++
4. FRESH SKINLAB 98% JEJU ALOE ICE UV SUN BLOCK FOR FACE & BODY SPF 50 PA++

According to Republic Act 3720 as amended, a cosmetic shall be deemed misbranded if its labeling is false or misleading in any particular. Furthermore, the IRR of Republic Act 9711 defines “misbranding” as giving unsubstantiated claims, misinformation or misleading information on the label or other information materials.

The aforementioned cosmetic products were found non-compliant with the existing standards due to failure to substantiate the claim Sun Protection Factor (SPF) 50. Also, the MAH, Healthy Innovation Distribution Inc., has made misrepresentation and false entries in the applications for product notification based on the Centers’ post evaluation activities and product information file (PIF) audit by declaring Coreholic Co., as the manufacturer which is inconsistent from the relevant documents submitted for notification, rendering the products unauthorized.

In light of the foregoing, the public is advised not to purchase the aforementioned misbranded products. 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 misbranded 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 jurisdiction.

Attachment:-> FDA-Advisory-No.2020-1757

FDA Advisory No. 2020-1738 || Public Health Warning Against the Purchase and Use Non-Compliant Cosmetic Products

The Food and Drug Administration (FDA) warns the public from purchasing and using the following non-compliant cosmetic products imported and distributed by the Market Authorization Holder (MAH), Healthy Innovation Distribution Inc., (Refer to the image provided in the attached annex):

1. FRESH SKINLAB 98% TOMATO GLASS SKIN SUGAR LIP SCRUB
2. FRESH SKINLAB 98% TOMATO GLASS SKIN VITAMIN C SERUM SHEET MASK
3. FRESH SKINLAB 98% TOMATO GLASS SKIN VITAMIN C SERUM SOAP
4. FRESH SKINLAB 98% TOMATO GLASS SKIN MAKEUP CLEANSING BALM
5. FRESH SKINLAB 98% TOMATO GLASS SKIN GENTLE FOAMING FACIAL CLEANSER
6. FRESH SKINLAB 98% TOMATO GLASS SKIN LIP THERAPY MASK
7. FRESH SKINLAB 98% TOMATO SUN GEL SPF50
8. FRESH SKINLAB 98% TOMATO GLASS SKIN SPF 50 FACE & BODY MIST
9. FRESH SKINLAB 98% TOMATO GLASS SKIN SLEEPING PACK
10. FRESH SKINLAB 98% TOMATO GLASS SKIN SPF 30 WATER DROP CREAM
11. FRESH SKINLAB 98% TOMATO GLASS SKIN SOOTHING GEL LOTION
12. FRESH SKINLAB 98% TOMATO GLASS SKIN pH 5.5 HYDRATING TONER
13. FRESH SKINLAB WATERMELON YOUTHFUL GLOW JELLY TONER MIST
14. FRESH SKINLAB 98% ALOE VERA SPF 50 FACE & BODY MIST
15. FRESH SKINLAB MILK WHITE BRIGHTENING JELLY PEEL
16. FRESH SKINLAB MILK WHITE TONE UP SUN CREAM SPF 30
17. FRESH SKINLAB MILK WHITE WHIP FOAMING FACE AND BODY SOAP
18. FRESH SKINLAB JEJU ALOE ICE COOLING FACIAL SHEET MASK
19. FRESH SKINLAB JEJU ALOE ICE pH 5.5 TONER
20. FRESH SKINLAB JEJU ALOE ICE FACE AND BODY MIST
21. FRESH SKINLAB JEJU ALOE ICE SOOTHING GEL
22. FRESH SKINLAB JEJU ALOE ICE WHIP FOAMING FACE & BODY SOAP
23. FRESH SKINLAB 98% JEJU ALOE ICE FOAM WASH
24. FRESH SKINLAB 98% JEJU ALOE ICE FACIAL SCRUB
25. FRESH JEJU ALOE ICE MAKEUP CLEANSING BALM
26. FRESH JEJU ALOE ICE UV SUN BLOCK SPF 50
27. FRESH SKINLAB CALAMINE ANTIBLEMISH CALMING TONER
28. FRESH SKINLAB CALAMINE ANTIBLEMISH CALMING SPOT CREAM
29. FRESH SKINLAB CALAMINE ANTIBLEMISH CALMING FOAM WASH
30. FRESH SKINLAB GREEN TEA & CUCUMBER ACNE CARE JELLY TONER MIST
31. FRESH SKINLAB COLLAGEN SPF 50 FACE AND BODY MIST
32. FRESH SKINLAB ARGAN OIL IN WATER FACE AND BODY MIST
33. FRESH SKINLAB OLIVE OIL IN WATER FACE AND BODY MIST
34. FRESH SKINLAB BEAUTY WATER
35. FRESH SKINLAB ACNE CARE LOTION
36. FRESH SKINLAB PORE REDUCING CREAM
37. FRESH SKINLAB LIGHTENING GEL
38. FRESH SKINLAB ALOE VERA FACE MIST
39. FRESH SKINLAB COLLAGEN FACE MIST
40. FRESH SKINLAB LIFTING EYE GEL
41. SUNGLOW BY FRESH TINTED LIPSCREEN SPF 50
42. SUNGLOW BY FRESH TINTED SUNSCREEN SPF50
43. SUNGLOW BY FRESH SUN MIST SPF 50
44. SUNGLOW BY FRESH SET AND FIX MATTIFYING SUNSCREEN POWDER
45. HELLO KITTY CHARCOAL PEEL OFF MASK
46. HELLO KITTY APPLE PEELING GEL
47. HELLO KITTY FACE MIST
48. CHERIMOA PANDA FACE MASK
49. CHERIMOA GHOST FACE MASK
50. CHERIMOA PENGUIN FACE MASK

The abovementioned products was verified NON-COMPLIANT by FDA through postmarketing surveillance 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” provides for the relevant functions, powers and duties of the FDA, including conduct of post-market surveillance system in monitoring health products.

Attachment:->FDA-Advisory-No.2020-1738

FDA Advisory No. 2020-1650 || Public Health Warning Against the Purchase and Use of Non-Compliant Cosmetic “ASHLEY SHINE KERATIN TREATMENT DEEP REPAIR”

The Food and Drug Administration (FDA) warns the public from purchasing and using the non-compliant cosmetic product imported by and distributed by the Market Authorization Holder (MAH), ELEGANT FUMES BEAUTY PRODUCTS INC.:

According to Republic Act 3720, a cosmetic shall be deemed to be misbranded if its labeling is false or misleading in any particular. Furthermore, IRR of Republic Act 9711 defines “misbranding” as giving unsubstantiated claims, misinformation or misleading information on the label or other information materials.

The aforementioned product was found to have misleading information on the label reflecting the local company address as “Manila Province, P.R. China” which is inconsistent with the information declared in the acknowledged product notification rendering the product as being misbranded. Furthermore, the MAH, Elegant Fumes Beauty Product Inc. in its letter to FDA dated 24 August 2020 admitted error and misprinting of local company address on the label of the aforementioned product.

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 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 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.2020-1650

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1650 || Public Health Warning Against the Purchase and Use of Non-Compliant Cosmetic “ASHLEY SHINE KERATIN TREATMENT DEEP REPAIR”

FDA Advisory No. 2020-1526 || Public Health Warning Against the Purchase and Use of the Following Non-Compliant Products_FRESH SKINLAB COLLAGEN SPF50

The Food and Drug Administration (FDA) warns the public from purchasing and using the following non-compliant cosmetic products imported and distributed by the Market Authorization Holder (MAH), Healthy Innovation Distribution Inc.:

  1. FRESH SKINLAB COLLAGEN SPF 50 FACE AND BODY MIST
  2. FRESH SKINLAB ALOE VERA FACE MIST
  3. SUNGLOW BY FRESH SUN MIST SPF 50
  4. FRESH SKINLAB 98% TOMATO GLASS SKIN SPF 50 FACE & BODY MIST

According to Republic Act 3720, a cosmetic shall be deemed to be misbranded if its labeling is false or misleading in any particular. Furthermore, IRR of Republic Act 9711 defines “misbranding” as giving unsubstantiated claims, misinformation or misleading information on the label or other information materials.

The aforementioned cosmetic products were found and tested to be non-compliant with the existing standards based on its failure to meet its Sun Protection Factor (SPF) 50 claim. Also, the MAH, Healthy Innovation Distribution Inc., has made misrepresentation and false entries in the applications for product notification based on the Centers’ post evaluation activities rendering the products as being misbranded.

In light of the foregoing, the public is advised not to purchase the aforementioned misbranded products. 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 misbranded 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 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.2020-1626

FDA Advisory No. 2020-1598 || Public Health Warning Against the Purchase and Use of the Non-Compliant Product ” CLINS UP ISOPROPYL ALCOHOL “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant product, ” CLINS UP ISOPROPYL ALCOHOL “.

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 (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 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 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.

Attachment:-> FDA-Advisory-No.2020-1598

FDA Advisory No. 2020-1597 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” CLINS UP ETHYL ALCOHOL “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” CLINS UP ETHYL ALCOHOL “.

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 (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 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 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.

Attachment:-> FDA-Advisory-No.2020-1597

FDA Advisory No. 2020-1557 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” PROFESSIONAL SKIN CARE FORMULA BY DR. ALVIN – KOJIC ACID SOAP “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” PROFESSIONAL SKIN CARE FORMULA BY DR. ALVIN – KOJIC ACID SOAP “.

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 (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 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 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.

Attachment:-> FDA-Advisory-No.2020-1557

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1557 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” PROFESSIONAL SKIN CARE FORMULA BY DR. ALVIN – KOJIC ACID SOAP “

FDA Advisory No. 2020-1556 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” PROFESSIONAL SKIN CARE FORMULA BY DR ALVIN KOJIC ACID SOAP “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” PROFESSIONAL SKIN CARE FORMULA BY DR ALVIN KOJIC ACID SOAP “.

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 (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 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 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.

Attachment:-> FDA-Advisory-No.2020-1556

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1556 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” PROFESSIONAL SKIN CARE FORMULA BY DR ALVIN KOJIC ACID SOAP “

FDA Advisory No. 2020-1555 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” PROFESSIONAL SKIN CARE FORMULA BY DR. ALVIN – REJUVENATING TONER “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” PROFESSIONAL SKIN CARE FORMULA BY DR. ALVIN – REJUVENATING TONER “.

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 (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 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 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.

Attachment:-> FDA-Advisory-No.2020-1555

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1555 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” PROFESSIONAL SKIN CARE FORMULA BY DR. ALVIN – REJUVENATING TONER “

FDA Advisory No. 2020-1545 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic HEAD & SHOULDERS DEEP CLEANSING

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, HEAD & SHOULDERS DEEP CLEANSING .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 29 July 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 (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 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, 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.

Attachment:-> FDA Advisory No.2020-1545

 

FDA Advisory No. 2020-1544 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic JENNA ESSENCE ALOE ROSE REVITALIZING GEL SPF30

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, JENNA ESSENCE ALOE ROSE REVITALIZING GEL SPF30.

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 30 July 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 (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 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, 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.

Attachment:->FDA Advisory No.2020-1544

 

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1544 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic JENNA ESSENCE ALOE ROSE REVITALIZING GEL SPF30

FDA Advisory No. 2020-1543 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SUTLA FLAWLESS PAPAYA SOAP

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, SUTLA FLAWLESS PAPAYA SOAP.

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 30 July 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 (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 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, 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.

Attachment:-> FDA Advisory No.2020-1543

 

FDA Advisory No. 2020-1579 || Public Health Warning Against the Purchase and Use of Vapor Product Refill (e-liquid) “GLUTTONY MAMON” Containing CANNABINOL

The Food and Drug Administration (FDA) warns the public from purchasing and using the vapor product refill GLUTTONY MAMON” which tested positive for the presence of CANNABINOL. The product was found to contain Liquid Cannabis which is considered as a dangerous drug under Republic Act No. 9165, otherwise known as the “Comprehensive Dangerous Drug Act of 2002”.

In light of the foregoing, the public is advised not to purchase the aforementioned product containing illicit drug substances, as this poses potential hazards to the consuming public.

All concerned establishments are warned not to distribute/sell the aforementioned product.

Law enforcement agencies and Local Government Units are requested to ensure that the product is 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 similar products, 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.2020-1579

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1579 || Public Health Warning Against the Purchase and Use of Vapor Product Refill (e-liquid) “GLUTTONY MAMON” Containing CANNABINOL

FDA Advisory No. 2020-1542 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic GLAMOURSKIN BLEACHING SOAP

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, GLAMOURSKIN BLEACHING SOAP.

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 30 July 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 (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 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, 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.

 

Attachment:-> FDA-Advisory-No.2020-1542

FDA Advisory No. 2020-1541 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic RICHMONDE® PAPAYA HERBAL SOAP

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, RICHMONDE® PAPAYA HERBAL SOAP.

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 30 July 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 (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 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, 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.

Attachment:-> FDA-Advisory-No.2020-1541

FDA Advisory No. 2020-1537 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic HAPPY ORGANICS ROSE-C WHITENING ECO ORGANIC FACE POWDER

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, HAPPY ORGANICS ROSE-C WHITENING ECO ORGANIC FACE POWDER .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 11 August 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 (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 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, 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.

Attachment:-> FDA Advisory No.2020-1537

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1537 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic HAPPY ORGANICS ROSE-C WHITENING ECO ORGANIC FACE POWDER

FDA-Advisory-No.2020-1536 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic USUPSO ROSE REFRESH ROLL ON

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, USUPSO ROSE REFRESH ROLL ON .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 11 August 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 (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 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, 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.

Attachment:-> FDA-Advisory-No.2020-1536

FDA Advisory No. 2020-1535 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic USUPSO SWEET-SCENTED OSMANTHUS RELIEVE ROLL ON

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, USUPSO SWEET-SCENTED OSMANTHUS RELIEVE ROLL ON.

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 11 August 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 (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 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, 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.

Attachment:-> FDA-Advisory-No.2020-1535

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1535 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic USUPSO SWEET-SCENTED OSMANTHUS RELIEVE ROLL ON

FDA Advisory No. 2020-1534 ||Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic CARICA HAIR CARE SOAP

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, CARICA HAIR CARE SOAP .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 11 August 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 (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 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, 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.

Attachment:-> FDA-Advisory-No.2020-1534

FDA Advisory No. 2020-1533 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic USUPSO PROFOUND PRETTY EYE QUICK-DRYING EYELINER

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, USUPSO PROFOUND PRETTY EYE QUICK-DRYING EYELINER .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 11 August 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 (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 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, 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.

Attachment:-> FDA Advisory No.2020-1533

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1533 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic USUPSO PROFOUND PRETTY EYE QUICK-DRYING EYELINER

FDA Advisory No. 2020-1532 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic USUPSO GRADIENT BEVELED EYEBROW PENCIL (DARK BROWN)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, USUPSO GRADIENT BEVELED EYEBROW PENCIL (DARK BROWN) .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 11 August 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 (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 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, 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.

Attachment:-> FDA-Advisory-No.2020-1532

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1532 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic USUPSO GRADIENT BEVELED EYEBROW PENCIL (DARK BROWN)

FDA Advisory No. 2020-1531 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic USUPSO COTTON NIB LIQUID EYELINER WITH ROLLER BALL (BLACK)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, USUPSO COTTON NIB LIQUID EYELINER WITH ROLLER BALL (BLACK) .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 11 August 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 (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 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, the online reporting facility, eReport can be accessed at erepo[email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Attachment:-> FDA Advisory No.2020-1531

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1531 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic USUPSO COTTON NIB LIQUID EYELINER WITH ROLLER BALL (BLACK)

FDA Advisory No. 2020-1530 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic USUPSO CHAMOMILE PETAL ESSENTIAL OIL HANDMADE SOAP

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, USUPSO CHAMOMILE PETAL ESSENTIAL OIL HANDMADE SOAP .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 11 August 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 (ww2.fda.gov.ph). It has a Se3315arch 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, 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.

Attachment:-> FDA-Advisory-No.2020-1530

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1530 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic USUPSO CHAMOMILE PETAL ESSENTIAL OIL HANDMADE SOAP

FDA Advisory No. 2020-1521 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic PIXY STIX FLAVORED LIP BALM (STRAWBERRY)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, PIXY STIX FLAVORED LIP BALM (STRAWBERRY).

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 29 July 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 (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 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, 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.

Attachment:-> FDA-Advisory-No.2020-1521

FDA Advisory No. 2020-1520 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SHINEMOIST HENNA WAX COLOR TREATMENT CHOCOLATE RED

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, SHINEMOIST HENNA WAX COLOR TREATMENT CHOCOLATE RED .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 29 July 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 (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 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, 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.

Attachment:-> FDA-Advisory-No.2020-1520

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1520 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SHINEMOIST HENNA WAX COLOR TREATMENT CHOCOLATE RED

FDA Advisory No. 2020-1519 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SPINNS WHY NOT – 2 COLORS CHEEK – COLOR ORANGE

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, SPINNS WHY NOT – 2 COLORS CHEEK – COLOR ORANGE.

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 29 July 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 (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 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, 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.

Attachment:-> FDA-Advisory-No.2020-1519

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1519 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SPINNS WHY NOT – 2 COLORS CHEEK – COLOR ORANGE

FDA Advisory No. 2020-1585 || Public Health Warning Against the Purchase and Use of Spray Paints Containing Significant Levels of Toxic Heavy Metal, Lead (Pb)

The Food and Drug Administration (FDA) warns the public against the purchase and use of spray paints which tested positive for significant levels of lead (Pb) upon the conduct of laboratory tests on the collected samples. Laboratory test results of thirty-seven (37) spray paint products showed that these products have exceeded the maximum limit of 90 parts per million (ppm).

Pursuant to its mandate under RA 9711 or the “FDA Act of 2009”, to ensure the safety and efficacy of health products in the country such as household/urban hazardous substances (H/UHS) that may have an effect on health, the FDA hereby issues this public health advisory on the following products, to wit:

  PRODUCT DETAILS
1 Anton/Acrylic Lacquer Spray Paint/Red (Hongda Red)
2 Colorz/Aerosol Spray Paint/Green (Silver Light Green)
3 Colorz/Aerosol Spray Paint/Red (Flash Red)
4 Colorz/Aerosol Spray Paint/Yellow (Lemon Yellow)
5 JM/Spray Paint/Green (Light Green)
6 JM/Spray Paint/Yellow (Medium Yellow)
7 King Sfon Spray Paint, Grass Green
8 Klomonkey/Spray Paint/Green (Fresh Green)
9 Koby/Multi-Purpose Aerosol/Green (Fresh Green)
10 Koby/Multi-Purpose Aerosol/Red (Suzuki Red)
11 Koby/Multi-Purpose Aerosol/Yellow (Canary Yellow)
12 Lotus/Acrylic Lacquer Spray Paint/Yellow
13 MR. D.I.Y. Spray Paint, Yellow
14 Parlux Spray Paint, Dark Green
15 Parlux Spray Paint, Suzuki Red
16 Powerbon/Aerosol Lacquer/Green (Jade Green)
17 Powerbon/Aerosol Lacquer/Red (Carmine Red)
18 Powerbon/Aerosol Lacquer/Yellow (Golden Yellow)
19 Pylox/Aerosol Lacquer/Blue
20 RStar Spray Paint/Green (Grass Green)
21 RStar/Spray/Yellow (Canary Yellow)
22 Sinag (White Body)/Spray Paint/Yellow (Medium Yellow)
  PRODUCT DETAILS
23 Sinag (White Body)/Spray Paint/Yellow (Medium Yellow)
24 Sinag/Spray Paint/Green (Fresh Green)
25 Sinag/Spray Paint/Orange (Orange Red)
26 Standard/Aerosol Spray Paint/Green (Light Green)
27 Standard/Aerosol Spray Paint/Yellow (Art Yellow)
28 Standard/Aerosol Spray Paint/Yellow (Orange Yellow)
29 Supemova/Spray Paint/Cream
30 Supemova/Spray Paint/Yellow (Orange Yellow)
31 Uni-Tech/All Purpose Spray Paint/Orange (Gongcheng Orange Yellow)
32 Uni-Tech/All Purpose Spray Paint/Yellow (Deep Yellow)
33 Uni-Tech/All-Purpose Spray Paint/Green (Grass Green)
34 White Tiger/Spray Paint/Red (Jialing Red)
35 Yandy Spray Paint, Deep Yellow
36 Yandy Spray Paint, Jade Green
37 Yao Dong Bang/Spray Paint/Green (Light Green)
*See attached photos for reference.

[1]Lead is a cumulative toxicant that affects multiple body systems and is particularly harmful to young children and can suffer profound and permanent adverse health effects, particularly affecting the development of the brain and nervous system. It also causes long-term harm in adults, including increased risk of high blood pressure and kidney damage. Exposure of pregnant women to high levels of lead can cause miscarriage, stillbirth, premature birth and low birth weight. There is no permissible level of exposure to lead that is known to be without harmful effects.

All concerned establishments are sternly warned and hereby directed to stop the distribution and sale of aforementioned products that pose unwarranted risks to health. Appropriate regulatory sanction shall be executed to establishments that are continuously marketing these products, upon issuance of this advisory.

To report any sale or distribution of these products, kindly email FDA via [email protected]

Dissemination of this Advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-1585

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1585 || Public Health Warning Against the Purchase and Use of Spray Paints Containing Significant Levels of Toxic Heavy Metal, Lead (Pb)

FDA Advisory No. 2020-1518 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic MYCHOICE EYEBROW PENCIL

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, MYCHOICE EYEBROW PENCIL.

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 29 July 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 (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 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, 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.

Attachment:-> FDA Advisory No.2020-1518

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