FDA warns whipped sunscreen formulations ineffective

Key takeaways:

• The FDA sent warning letters to five brands marketing unapproved sunscreen formulations.
• The agency stated whipped, mousse and foam formulations may not provide adequate sun protection.

The FDA’s recent issue of five warning letters to brands illegally marketing whipped, mousse and foam sunscreen products highlights concerns over consumer safety and industry ethics.

On Aug. 6, the FDA sent warning letters to Supergoop!, Vacation Inc., Kalani Sunwear, Fallien Cosmeceuticals (TiZo brand) and K & Care Organics for “misbranding” their whipped, mousse and foam sunscreen products by claiming they could prevent sunburn. The marketed claim violated the FDA’s 2019 proposed rule, which states sunscreens may only be sold in oil, lotion, cream, gel, butter, paste, ointment, stick, spray or powder form.

“There is no FDA-approved application in effect for your drug,” the FDA said in the warning letters. The agency gave the brands 15 working days to respond to the warning letters or face legal repercussions.

Whipped, mousse and foam sunscreens have gained popularity in recent years with products like Vacation’s Classic Whip SPF 30, which is shaped like a whipped cream bottle that reads “dessert for your skin,” garnering nearly 400 reviews online.

However, the FDA has warned consumers against using these formulations, stating on X, “Beware of sunscreen products in mousse form because they might 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.

“The way sunscreen efficacy is determined is you have to cover an area of skin with 2 mg/cm² of sunscreen and measure how much of the UV radiation is blocked in that area,” Rossi, who owns his own sunscreen line, told Healio. “But foams, mousses and whips, because they are aerated, will leave gaps that allow UV rays in.”

According to Rossi, consumers who continue to use these products may face a risk for sunburn.

“The product may not provide the SPF protection that it’s advertising because the formulation is too light and airy,” Rossi said. “When the user puts it on, they may not necessarily get the even amount of coverage that you would need to get that SPF.”

Not only may these items leave the skin unprotected, according to Rossi, but the refrigerants used in the products are harmful to the environment and may be dangerous to inhale.

For example, the refrigerant hydrofluorocarbon-152a, found in Supergoop!’s PLAY Body Mousse SPF 50, is a greenhouse gas with a global warming potential that is 124 times more impactful than carbon dioxide, according to the Environmental Protection Agency. Inhaling hydrofluorocarbon-152a can cause dizziness, nausea and other concerning adverse events, according to safety data from National Refrigerants, Inc.

It is unclear when each of these products launched, but according to Rossi, consumers have had access to these items for a few years, with online reviews on Supergoop!’s PLAY Body Mousse SPF 50 dating to 2018.

“The FDA is dealing with a lot of things,” Rossi said. “Yes, we wish they could be on top of everything, but it is hard to regulate every single OTC product.”

After the FDA issued its warning letters, many of the companies agreed to comply with the agency’s directives.

“At Supergoop! we remain committed to innovation in sun care and the highest standards of product efficacy and safety,” Supergoop! said in a statement to Healio. “The recent communication from the FDA regarding our PLAY SPF 50 Body Mousse is focused on product labeling and has nothing to do with its safety, effectiveness or formula. We are working closely with the FDA to resolve this matter as we continue to uphold the high standards our consumers expect from us.”

However, experts remain concerned about how these products were allowed to reach retail shelves in the first place.

“It is scary that these formulations were not studied by the FDA yet were able to be sold. I know the approval process a manufacturer has to go through for sunscreen. The fact that these brands wouldn’t go through it is very disconcerting from a consumer perspective,” Rossi said. “These are big brands that have been doing this. They preach safety and efficacy, but at the end of the day, this is a miss for them.”

For more information:

Anthony Rossi, MD, FAAD, FACMS, can be reached Anthony@Rossi.Derm.com; Instagram: @dranthonyrossi.

References:

• Acceptable refrigerants and their impacts. https://www.epa.gov/mvac/acceptable-refrigerants-and-their-impacts. Accessed Aug. 18, 2025.
• Beware of sunscreen products in mousse form because they might not be effective. https://x.com/FDA_Drug_Info/status/1955297014234706061. Published Aug. 12, 2025. Accessed Aug. 18, 2025.
• Classic Whip SPF 30. https://www.vacation.inc/products/classic-whip-spf-30. Accessed Aug. 18, 2025.
• PLAY Body Mousse SPF 50. https://supergoop.com/products/super-power-sunscreen-mousse?srsltid=AfmBOoqfRLSHEjaM3E1Fqkl1wbMg70wSflbj1E6wmzt54zCOfCmNo_q7&variant=31338665476194. Accessed Aug. 18, 2025.
• Safety Data Sheet. https://refrigerants.com/wp-content/uploads/SDS-R152a.pdf. Published January, 2024. Accessed Aug. 18, 2025.
• Warning Letter – Fallien Cosmeceuticals Ltd. dba Fallene Ltd. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fallien-cosmeceuticals-ltd-dba-fallene-ltd-711006-08062025. Published Aug. 6, 2025. Accessed Aug. 18, 2025.
• Warning Letter – K & Care Organics. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025. Published Aug. 6, 2025. Accessed Aug. 18, 2025.
• Warning Letter – Kalani AB dba Kalani Sunwear. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kalani-ab-dba-kalani-sunwear-710998-08062025. Published Aug. 6, 2025. Accessed Aug. 18, 2025.
• Warning Letter – Vacation Inc. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vacation-inc-706039-08062025. Published Aug. 6, 2025. Accessed Aug. 18, 2025.