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The Food and Drug Administration (FDA) hereby advises the public that the cosmetic product BABYFLO® BABY COLOGNE PINK FANTASY as listed in FDA Advisory No. 2021-0502 “Public Health Warning Against the Purchase and Use of Cosmetic Product Containing Banned Ingredient/s dated 05 March 2021 is hereby amended.

The Market Authorization Holder (MAH), Philusa Corporation., has conducted a voluntary recall and complete disposal of specific batch of the cosmetic product affected by the said Advisory.

According to the MAH, the inventory with identified lot/batch number, manufacturing and expiration date are no longer available in the market and have been voluntarily recalled and properly disposed of.

The MAH is urged to strictly comply with FDA implemented laws, rules and regulations and to closely monitor the marketing of the subject products. Nothing in this Advisory shall preclude the FDA from pursuing further actions, as it may deem necessary against the MAH, should the subject product be confirmed to contain banned ingredients.

In view thereof, FDA Advisory No. 2021-0502 is hereby amended accordingly. To report any suspicious activity and/or product, kindly e-mail us via [email protected]. For more information and inquiries, please e-mail us at [email protected] or call us at the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) hotline (02) 857-1900 local 8113/8017.

Dissemination of this advisory to all concerned is hereby requested.