The Food and Drug Administration (FDA) warns the public from purchasing and using the following violative cosmetic products, which were detected to contain BANNED INGREDIENTS (LINCOMYCIN, CLOBETASOL PROPIONATE, RHODAMINE B, ISOBUTYL PARABEN) in cosmetic products, as reported in the ASEAN Post-Marketing Alert System (PMAS). These ingredients are not allowed to be part of a cosmetic product as per ASEAN Cosmetic Directive (ACD). The table below indicates the particulars of the violative cosmetic products:
1. GIA SKINPERT+SEBUSTOP ACNE DEFYING CREAM
2. DIAMOND SHINE WHITENING CREAM ORIGINAL
3. MILA VELVET MATTE LIPSTICK (SHADE: HOT DAMN)
4. OXYGLOW HERBALS DAY CREAM
The aforementioned products have been tested by the Health Sciences Authority, Singapore, as part of their post-marketing surveillance activities and results of the laboratory analyses show that these products are not compliant with the technical standards set forth by the ACD.
Lincomycin, and Clobetasol propionate are not allowed to be part of cosmetic products as these are classified as drug products in the Philippines because of their multiple serious adverse effects when used indiscriminately without medical supervision. Parabens can cause dermatitis to individuals who are sensitive to these ingredients. Rhodamine B can cause irritation when in contact with the skin and the eyes, and has been prohibited for use in cosmetics as it may be carcinogenic.
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 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 or distribution, complaint and/or adverse event on the use of the violative cosmetic product, the online reporting facility, eReport can be accessed at ereport@fda.gov.ph, or call us at the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) hotline (02) 8857-1900 loc. 8113 or 8107.
Dissemination of this advisory to all concerned is hereby requested.