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It just came to light that the U.S. Food & Drug Administration sent WARNING LETTERS (that’s how the agency writes it—in all caps) to Supergoop! and Vacation regarding their foam-format sunscreens, and it kind of feels like watching two of your friends get called to the principal’s office.
Issued on August 6, the letters state, in regard to Supergoop! Play Body Mousse SPF 50 and Vacation Classic Whip SPF 30 respectively, “No FDA-approved application … is in effect for your drug product," and that "sunscreens in dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder may only be lawfully marketed … To date, no final order has been issued … that would authorize marketing of a sunscreen in foam (aka, mousse or whipped cream) dosage form." The FDA says the products are in violation of the Federal Food, Drug, and Cosmetic Act, which sets the rules on how the administration regulates and oversees the safety of cosmetics, drugs, and food.
In the case of Vacation’s Classic Whip, the FDA also noted potential dangers of drugs or cosmetics marketed similarly to food products. “Packaging drug products in containers that resemble food containers commonly used by adults and children can mislead consumers into mistaking the products for food, which is of particular concern as this increases the risk of accidental ingestion,” the administration’s letter to Vacation reads.
Naturally, this has caused confusion, incredulity, uncertainty, and curiosity among fans of the brands and the skin care industry as a whole. Play Body Mousse and Classic Whip are both beloved sunscreens, revered for their whimsically whipped texture and surprisingly convenient application experience. But the very thing consumers love about both products is the very thing that seems to have gotten them into a compliance pickle.
Both letters state that the brand in question has 15 working days to inform the agency, in writing, of specific steps it has taken to correct any violations or to respond with the reasons its product isn’t in violation of the law with supporting information. It’s unclear what would happen after 15 days, regardless of how the brands respond; Allure asked the FDA for more specifics on that 15-day timeline and what follows and didn’t receive an answer amid its responses to our other inquiries. But from what the brands that received warning letters tell us, it seems like they’re on top of it.
“At Vacation Sunscreen, we take regulatory compliance seriously and appreciate the opportunity to address the U.S. Food and Drug Administration’s recent Warning Letter,” reads a statement sent to Allure by Vacation’s representatives. “We have full confidence in the safety, efficacy, and integrity of our product. We are committed to working collaboratively with the FDA to satisfactorily resolve this matter."
Supergoop!’s representatives provided a similar response: “At Supergoop! we remain committed to innovation in sun care and the highest standards of product efficacy and safety. 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.”
Supergoop! and Vacation have sold these foam-format sunscreens for years. It begs the question: Why is the FDA issuing these warnings now? We straight-up asked representatives of the FDA that question, to which they responded, “We don’t address questions about the timing of warning letters because we take a risk-based approach.” It’s unclear what that risk may be (once again, we asked but have yet to receive a response). Los Angeles-based board-certified dermatologist Ava Shamban, MD—who has conducted numerous clinical trials for the FDA—notes that she is not aware of any widespread complaints from consumers about either of the formulas at hand. That said, she adds: “At any time, the FDA can not only revisit but even take action against a product that it considers misbranded or unsafe.”
But let’s back up for a sec. If the FDA considers these products misbranded, as the letters state, how did they seemingly have FDA approval and get on shelves in the first place? “Sunscreens, anti-cavity toothpaste, and antiperspirants are all over-the-counter drugs, a special category of drugs that are available without a prescription and can be marketed as long as they comply with the associated OTC drug monograph,” which acts kind of like a recipe book, according to cosmetic chemist Kelly Dobos. This monograph specifies acceptable ingredients, dosages, formulations, test methods, and passing criteria where applicable, so if a product conforms, it can be marketed without individual FDA approval.
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Supergoop! confirmed with Allure that Play Body Mousse is marketed pursuant to the OTC monograph, which does not require pre-approval by FDA, and the brand assessed the product to ensure compliance with all monograph requirements; Vacation tells Allure they adhere to all FDA-required methods of testing sunscreen for SPF levels and efficacy, and that all Vacation products are registered with the FDA.
Basically, a product’s formula can check all the regulatory boxes that allow it to hit shelves, but new formatting innovations like mousse can slip through the cracks. And for reasons that aren’t yet clear, when it comes to these two products, the FDA has just taken action now.
Dobos suspects that this seemingly sudden focus on foam sunscreens may have something to do with how a recent U.S. House Committee on Energy and Commerce hearing highlighted the FDA’s struggle to keep pace with the regulation of over-the-counter drugs due to staffing cuts and resource limitations. “I think the FDA just doesn’t have the resources to be as proactive about enforcement as we’d like when it comes to sunscreens, and this includes evaluating new active ingredients and test methods,” she says. By that logic, perhaps issuing these warnings had simply been on the agency’s ever-expanding to-do list.
Another expert theory: The sheer virality of foam sunscreens might have inspired the FDA to take a closer look at them. “These products are increasingly popular across social media and specifically with the younger generations. [They’re] fun to use, sensorial, and visually appealing,” Dr. Shamban says. “That level of visibility may have caught enough attention to work its way to the FDA, contributing to the warning pending further review.”
Regardless of why it’s happening now, board-certified dermatologist Mona Gohara, MD, is glad it is—and that’s nothing personal against Supergoop! and Vacation. “I’m not privy to FDA timing, but it is a good sign that sun protection is a priority, as it should be,” she tells Allure. “With rising awareness around skin cancer and the importance of consistent SPF use, ensuring that products meet established safety and efficacy standards is critical.”
Cosmetic chemist Amanda Lam, on the other hand, thinks these warning letters are “such a bummer for sunscreen innovation.” While she says she understands the regulatory compliance issues, “I think there are much bigger issues within the sunscreen world, like lack of UV filters and greenwashing, to go after instead of targeting these formats.” Dobos concurs that there’s much room for improvement when it comes to the FDA’s regulatory framework for sunscreens. “I’ve long advocated for updates, not just to allow innovation in active ingredients and product formats, but also to improve the way we test and label these products.”
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But is there even any evidence that foam sunscreens aren’t as effective or safe as all of the other approved formats? Lam isn’t so sure. “It may be hard to gauge how much sunscreen you are actually using with a mousse since there is so much air incorporated into it, but that is the same [issues with] a spray aerosol sunscreen,” which is an FDA-approved format. Mousse sunscreens, Lam says, are basically just standard sunscreen lotions that are thin enough to be dispensed in a whipped form.
To make a fair assessment of the safety of any foam or mousse sunscreen, Dobos says she’d need to see exactly how it’s tested. “If the product is tested before it’s dispensed as foam, that raises concerns about whether the final format still performs as expected and if consumers are applying enough,” she says. (Again, both Vacation and Supergoop! maintain their testing is up to regulatory par—that said, neither would share the specifics of their testing processes.)
This type of sunscreen isn’t going to suddenly disappear from the market as a result of these warning letters—at least not immediately—and to be perfectly clear, there’s nothing inherently dangerous about the formula of SuperGoop!’s Play Body Mousse or Vacation’s Classic Whip (unless you inexplicably do attempt to eat it). But, as with any sunscreen format, correct and thorough application is imperative. “Ultimately, what makes a product effective is how a consumer uses it,” Lam says. “Mousses may have the right amount of UV filters, boosters, and film formers, but if a consumer is not using enough, then it becomes less effective. This is the same with all types of sunscreen.”
And as so many dermatologists have told us over the years, the best sunscreen is the one you actually use. “Using the mousse products with an SPF of 30 or above versus no sunscreen? In my book, mousse would be the winner,” Dr. Shamban says. “However, as there is a concern without further testing and review, some may want to switch until such time as the FDA lifts the warning.” If you like to use whipped sunscreens, do with this information what you will.
