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The Food and Drug Administration (FDA) warns the public from purchasing and using the adulterated cosmetic product DONG BANG® WIPES HAPPY BABY which tested positive for the presence of METHYLISOTHIAZOLINONE and METHYLCHLOROISOTHIAZOLINONE. Such ingredients are prohibited to be used in leave-on cosmetic products as per Annex VI, Reference No. 39 of the ASEAN Cosmetic Directive.

The mixture of Methylisothiazolinone and Methylchloroisothiazolinone have been listed in Annex VI/39 of the ASEAN Cosmetic Directive to be used as a preservative in the finished cosmetic products. However, the use of the said ingredients have been prohibited in leave-on cosmetic products in the Philippines through the issuance of FDA Circular No. 2015-008 as a product of the 21st  ASEAN Cosmetic Committee (ACC), 20th and 21st ASEAN Cosmetic Scientific Body (ACSB) and 4th ASEAN Cosmetic Testing Laboratory Committee (ACTLC) Meetings.

The ban of the mixture Methylisothiazolinone and Methylchloroisothiazolinone as ingredients in leave-on cosmetic products have been ordered since the said ingredients are well recognized as skin sensitizer.

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 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 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 jurisdiction.

Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8113 or 8107.

To report any sale or distribution of the afore-mentioned cosmetic product, the online reporting facility, eReport can be accessed at  www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-207