The Food and Drug Administration (FDA) warns the public from purchasing and using the following violative cosmetic products, which tested positive for the presence of HYDROQUINONE, TRETINOIN and/or OTHER BANNED INGREDIENTS*, respectively, 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).
1. SIFU KUNYIT DAY CREAM
2. SIFU KUNYIT NIGHT CREAM
3. SPARKLE BEAUTY CREAM
4. BB GLOW SOUL CREAM
5. BEAUTY SLEEP TREATMENT CREAM
6. BEAUTYWISE REJUVENATING CREAM
7. BEAUTYWISE REJUVENATING TONER
8. OXY CREAM BY VIPROLABS
The aforementioned products have been tested by the National Pharmaceutical Agency, Malaysia, 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.
Hydroquinone, Tretinoin, Betamethasone, and Clotrimazole 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. Additionally, tretinoin may also cause harm to developing fetus. Women planning to get pregnant or are already expecting are strongly advised to avoid using products containing tretinoin.
In light of the foregoing, the public is advised not to purchase the aforementioned violative 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 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 firstname.lastname@example.org, 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.