FDA WARNING_LETTER - Supergoop! - May 02, 2025

The FDA issued a warning letter to Supergoop, located at 200 East Grayson Suite #110, San Antonio, TX, on August 6, 2025, following a review conducted on May 2, 2025. The review focused on the labeling and marketing of their product, "Supergoop! PLAY SPF 50 BODY MOUSSE," available for purchase online and through social media platforms. The FDA identified the product as a drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it is intended for the prevention of sunburn, thus affecting the body"s structure or function.

The main violation highlighted is that the product is marketed as an over-the-counter (OTC) sunscreen drug without an FDA-approved application, as required under section 505 of the FD&C Act. The product does not conform to the conditions of the applicable OTC monograph for sunscreen drug products, specifically because it is in a mousse form, which is not authorized under current FDA regulations for sunscreens.

The FDA requires Supergoop to address these violations by ensuring compliance with federal law and FDA regulations. The company must submit a written response within 15 working days detailing the corrective actions taken, including documentation. Failure to comply may result in legal actions such as product seizure or injunction. Supergoop is advised to send their response to the FDA"s Office of Unapproved Drugs and Labeling Compliance via email, including the unique identifier “711018” in the subject line.