Sunscreens sold without a prescription are treated as drugs under U.S. law because they protect against sunburn, skin cancer, and early skin aging. The FDA currently allows forms like oils, creams, lotions, sticks, gels, powders, ointments, pastes, and sprays. But foams, mousses, and whipped types are not approved. For these to be sold legally, companies must first get FDA approval through the new drug application process.
The FDA says companies must apply for approval before selling sunscreens in any form other than oils, lotions, creams, gels, butters, pastes, ointments, sticks, sprays, or powders, Today.com reported.
On August 18, the FDA sent warning letters to five companies for selling these unapproved products: Supergoop!, Vacation Inc., Kalani Sunwear, K & Care Organics, and Fallien Cosmeceuticals (maker of TiZO sunscreen).
The FDA also cautioned consumers not to use these products, posting on X: “Beware of sunscreen products in mousse form-they may not be effective.”
According to Anthony Rossi, MD, FAAD, FACMS, assistant attending of dermatologic, Mohs, cosmetic and laser surgery at Memorial Sloan Kettering Cancer Center and founder of Dr. Rossi Derm MD Skincare, it is “common sense” that these formulations may not be effective.
Sunscreens are considered over-the-counter drugs, so they are held to a different standard compared with other skincare products, Adam Friedman, MD, professor and chair of dermatology at George Washington University School of Medicine and Health Sciences, Washington, DC, said in an interview.
The companies selling mousse sunscreen products have not gone through the proper testing, “so we don’t know whether the SPF [sun protection factor] advertised is actually true,” Friedman said.
The FDA’s recent warnings to Supergoop and Vacation Inc. highlight that, even though sunscreens are sold over the counter, they are still strictly regulated as drugs. Products that don’t follow approved formats or packaging rules can be considered misbranded under federal law. Companies wanting to launch new types of sunscreen must meet FDA requirements to avoid penalties and protect consumers.
Reference
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
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