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The FDA has issued warnings to several manufacturers of “mousse” or “whipped cream” sunscreen products, according to the agency’s website. 

Over-the-counter sunscreen products are regulated as drugs under the Federal Food, Drug, and Cosmetic Act because they are intended to prevent sunburn and reduce the risk for skin cancer and premature skin aging. However, the currently approved formulations include oils, creams, lotions, sticks, gels, powders, ointments, pastes, and sprays but not foam, mousse, or whipped formulas. Therefore, these formulations need to go through the new drug application process to earn FDA approval.

As of August 18, warnings have been sent to five companies: Supergoop!, Vacation Inc., Kalani Sunwear, K & Care Organics, and Fallien Cosmeceuticals (manufacturer of TiZO sunscreen), according to the FDA.

For example, the warning letter to Vacation Inc. states that the company’s product is misbranded and, therefore, misleading to consumers. “To date, no final order has been issued by the Secretary under 505G(b) or 505G(c) that would authorize marketing of a sunscreen in foam (aka, mousse or whip) dosage form,” the letter states.

In addition, Vacation, in particular, markets sunscreen products similar in appearance to whipped cream products, both in the packaging and dispenser style. The website’s description of the bottle’s actuator producing “perfect, star-shaped mountains of foam, inspired by everyone’s favorite after-dinner indulgence” has prompted concerns about ingestion by children who mistake it for actual whipped cream.

Efficacy Unconfirmed

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.

Even if the companies had tested the products, mousses are not currently within the FDA’s sunscreen monograph and would have to be added, although that may happen in the future if companies research the effectiveness of the products correctly, he noted.

Part of the testing process is to determine how the vehicle interfaces with the skin and affects the product’s ability to protect skin from sun damage, Friedman explained.

Ultimately, the best sunscreen is the one someone will use consistently, he pointed out. But there is no quality assurance with any of the mousse sunscreens and the companies’ responses to the FDA warnings remain to be seen.

The popularity of the mousse and whipped sunscreen products may promote appropriate testing, and arguably, using a mousse sunscreen could be an improvement over using no sunscreen at all, Friedman told Medscape Medical News. However, he advises clinicians to stop short of actively endorsing these products if patients ask about them.

“Be honest with patients,” he said. “We don’t know whether these products are safe and effective because the manufacturers didn’t follow the rules before marketing them.”

Friedman declared having no relevant financial conflicts to disclose.