FDA Advisory No. 2020-419-A || Lifting the Advisory on the Notified Product “BLACK BEAUTY® PROTECT CUTICLE COAT PROTECTIVE HEALTH SHIELD SERUM” under FDA Advisory No. 2020-419 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic BLACK BEAUTY® PROTECT CUTICLE COAT PROTECTIVE HEALTH SHIELD SERUM” dated 13 March 2020

The Food and Drug Administration (FDA) informs the public that the Cosmetic product BLACK BEAUTY® PROTECT CUTICLE COAT PROTECTIVE HEALTH SHIELD SERUM with Notification No. 1000006215663 has been notified by the Market Authorization Holder, Philusa Corporation, 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. 2020-419 and FDA Order No. 2020-251 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.2020-419-A

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