FDA Warns Five Brands Over Mousse-Form Sunscreens

The U.S. Food and Drug Administration issued warning letters to five skincare brands over sunscreen products sold in mousse, foam, or whipped-cream-style packaging, saying those products are misbranded drugs that have not received FDA approval for those formats. The agency specified that sunscreens marketed in forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray or powder require a separate authorization to be marketed as effective sunscreen. Recipients were given 15 working days to respond with corrective actions or to come into compliance.

The letters make clear that, as of now, there are no FDA-approved applications in effect for the brands’ mousse-form products. In the communications, the FDA emphasizes that marketing a sunscreen in a foam or mousse dosage form without an approved application violates federal law. In addition to questions of regulatory status, the agency flagged misbranding concerns related to packaging that resembles food containers, warning that containers similar to whipped-cream canisters may mislead consumers and increase the risk of accidental ingestion.

Among the brands cited are Supergoop!, Vacation Inc., Kalani Sunwear,...