FDA Targets Whipped Sunscreens in Warning Letters

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Recently, the US Food and Drug Administration (FDA) reviewed products for and issued separate warning letters to 2 companies, Supergoop and Vacation Inc., regarding the marketing of their sunscreen mousse products without FDA approval.^1,2 Both enforcement actions center on the same regulatory issue: the sale of over-the-counter (OTC) sunscreen in a foam or mousse dosage form, which is not currently permitted under existing FDA regulations without specific agency authorization.

Background

OTC sunscreen products are regulated as drugs under the Federal Food, Drug, and Cosmetic (FD&C) Act because they are intended to prevent sunburn and reduce the risk of skin cancer and premature skin aging. These products must comply with the requirements outlined in Section 505G of the FD&C Act, which governs the marketing of nonprescription drugs without an approved application. Sunscreens that meet the applicable conditions in the FDA’s administrative order, OTC Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, are generally recognized as safe and effective (GRASE).³

However, Section 505G(m)(2) of the FD&C Act states that sunscreen dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder may only be marketed if specifically authorized by an FDA order. As of August 2025, the agency has not issued any such order permitting sunscreen in foam, mousse, or whip forms. This means these products cannot be lawfully marketed in the United States without an FDA-approved new drug application.

Findings in the Supergoop Warning Letter

On May 2, 2025, the FDA reviewed product labeling resulting in a warning letter to Supergoop concerning its “PLAY SPF 50 Body Mousse.” Product labeling and promotional materials described the product as a “lightweight, whipped sunscreen mousse” that is water- and sweat-resistant, antioxidant-rich, and designed for family use. These claims align with sunscreen’s established intended uses for disease prevention, triggering drug classification under the FD&C Act.¹

The FDA determined that the mousse dosage form is not an approved sunscreen format under the OTC monograph system and that no final order authorizing such a format exists. Consequently, the product was deemed misbranded under Section 502(ee) of the FD&C Act. The agency instructed Supergoop to respond within 15 working days, outlining corrective measures or providing supporting evidence for compliance.

Findings in the Vacation Inc. Warning Letter

On March 5, 2025, the FDA reviewed products from and issued a similar warning to Vacation Inc. regarding its “Classic Whip Broad Spectrum SPF 30 Sunscreen Mousse” and “Classic Whip Glow Broad Spectrum SPF 30 Shimmer Sunscreen Mousse.” The products were marketed with descriptors such as “dessert for your skin,” “lighter-than-air,” and “fluffy, glistening dollops,” and sold in canisters resembling whipped cream containers.²

In addition to the unapproved dosage form concern shared with Supergoop, FDA cited an additional misbranding violation under Section 502(i)(1) of the FD&C Act. This provision prohibits drug packaging that is misleading in form or appearance. FDA determined that the whipped cream–style packaging could be mistaken for food products, increasing the risk of accidental ingestion—particularly among children.

Regulatory Implications

These enforcement actions underscore the importance of both formulation compliance and packaging considerations in OTC drug marketing. Even if an active ingredient and SPF level are consistent with monograph requirements, the dosage form must be specifically permitted. The FDA’s position reflects a broader emphasis on dosage form safety, labeling accuracy, and the prevention of unintentional misuse.

For sunscreen manufacturers, the case illustrates that innovation in product texture, delivery, or packaging must be balanced with regulatory constraints. Novel formats may require formal FDA review and approval prior to marketing. Furthermore, packaging that closely imitates food items can trigger additional regulatory scrutiny under misbranding provisions, regardless of the product’s intended function.

Next Steps for the Companies

Both Supergoop and Vacation Inc. have been given the opportunity to respond to the FDA within 15 working days of the letters, detailing corrective actions or providing evidence to support their compliance position. Failure to adequately address the violations could result in enforcement actions, including product seizure or injunction.

Conclusion

The recent FDA letters to Supergoop and Vacation Inc. serve as a reminder to the skin care and cosmetics industry that sunscreen products, though widely available without prescription, remain tightly regulated as OTC drugs. Any deviation from approved dosage forms or packaging standards can render a product misbranded under federal law. Companies seeking to introduce novel formats or designs must ensure compliance with the FD&C Act, both to avoid regulatory action and to maintain consumer safety.

Reference

1. Warning letter to Supergoop! LLC. Silver Spring, MD. Public release. US FDA. May 2, 2025. Accessed August 14, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters
2. Warning letter to Vacation Inc. Silver Spring, MD. Public release. US FDA. March 5, 2025. Accessed August 14, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters
3. Questions and answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S. Silver Spring, MD. News release. US FDA. June 23, 2011. Accessed August 14, 2025. https://www.fda.gov/drugs/understanding-over-counter-medicines/questions-and-answers-fda-announces-new-requirements-over-counter-otc-sunscreen-products-marketed-us#top