# FDA WARNING_LETTER - Ultimark Products - April 19, 2022

Source: https://www.keypedia.com/records/warning_letter/ultimark-products/c0cb7844-5d63-4868-b00c-2591ac8bd524

> FDA WARNING_LETTER for Ultimark Products on April 19, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Ultimark Products
- Inspection Date: 2022-04-19
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Mr. Zuckerberg on April 13, 2022, concerning the distribution of PORCELANA DAY SKIN LIGHTENING CREAM. The product is cited as an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FDA determined PORCELANA DAY SKIN LIGHTENING CREAM is a drug intended for skin bleaching, based on claims on its label and website (Porcelana.com), such as "SKIN LIGHTENING CREAM," "FADES DARK SPOTS," and containing "Hydroquinone U.S.P. 2%." As a skin bleaching drug, it falls under section 505G(a)(4) of the FD&C Act, which deems such products not generally recognized as safe and effective (GRASE) per a 2006 proposed rule.

Consequently, the product is considered a new drug requiring an approved new drug application under section 505 of the FD&C Act, effective September 23, 2020. No such application exists for PORCELANA DAY SKIN LIGHTENING CREAM, violating section 505(a) and 301(d) of the FD&C Act. Furthermore, it is misbranded under section 502(ee) and 301(a) of the FD&C Act because it lacks an approved application and does

## Related Officers

- [Carolyn E. Becker](https://www.keypedia.com/people/carolyn-e-becker/ad2daae5-dda1-4b9c-a69a-775997e7b60b)

Company: https://www.keypedia.com/companies/ultimark-products/4defcb6f-b823-42a4-8f98-5eb2f8f2238c

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c