Key Takeaways:
The best sunscreen is the one you apply liberally and often. For many consumers, whipped formulations make the usually tedious process less of a need and more of a want. But a recent warning from the U.S. Food and Drug Administration (FDA) is deflating the fun from these SPF formats.
On August 6, the FDA issued warning letters to five sunscreen brands, including Vacation Inc. and Supergoop!, for marketing unapproved whipped, foam, and mousse sunscreen formats, not permitted under the current FDA monograph. As a result, these products cannot be lawfully marketed in the United States without an FDA-approved new drug application.
Breaking Down the FDA’s Case Against Foam SPF
Under the U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act), sunscreens are regulated as drugs, which means they must adhere to specific dosage form and packaging standards. Sunscreen products are "generally recognized as safe and effective (GRASE)" and not considered new drugs if they adhere to the conditions outlined in the applicable over-the-counter (OTC) monograph.
For sunscreens, this is specified in the final administrative order, which stipulates that “sunscreens in dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder can only be legally marketed without an approved application under Section 505 of the FD&C Act.”
Since foam or mousse products were not included in the initial OTC review, these types of products cannot be sold without either an FDA administrative order that adds them to the monograph after their safety, effectiveness, and consumer-use data have been assessed, or an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) that includes product-specific information—all which could take decades for FDA approval.
“To date, no final order has been issued by the Secretary [of Health and Human Services] under 505G(b) or 505G(c) that would authorize marketing of a sunscreen in foam (aka, mousse or whip) dosage form,” the warning letter stated. “There are no FDA-approved applications in effect for your drug products [in these forms].”
Additionally, Vacation Inc. was hit with another violation for using metal canisters that resemble whipped cream containers. The FDA concluded that the product’s packaging was "made, formed, or filled as to be misleading" to US consumers accustomed to purchasing food in such containers.
“Specifically, your sunscreens are presented in metal canisters with a[n] 'authentic tilt valve actuator’ that outputs a star-shaped foam and have a strong overall resemblance to the metal canisters ordinarily used to package whipped cream products and similar dessert toppings,” the warning letter read. “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 FDA issued warning letters to five brands, granting each 15 working days to respond. Each brand must outline corrective measures (including stop sale, relabeling, repackaging, recall, or seeking approval) or present evidence of compliance. Noncompliance could lead to enforcement actions such as product seizures or injunctions.
“At Supergoop! we remain committed to innovation in suncare and the highest standards of product efficacy and safety,” a representative told BeautyMatter in a statement. “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.”
Vacation Inc. issued a similar statement, noting that the brand “takes regulatory compliance seriously and appreciates the opportunity to address the U.S. Food and Drug Administration’s recent warning letter.”
The brand added: “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.”
In addition to the warning letters, the FDA also advised consumers to avoid these types of sunscreen products in a post on X this week.
“Beware of sunscreen products in mousse form because they might not be effective,” the post read.
A Question of Safety
Despite FDA warnings to consumers about this product format, mousse sunscreens are experiencing significant growth, with a 234.1% year-over-year (YoY) increase across Google Search and TikTok, indicating very high growth, according to Spate. Foam sunscreen is also growing +65.7% YoY on Google Search.
“Mousse textures are visually appealing, easy to apply, and are fun, which can drive social media buzz and consumer engagement,” said cosmetic chemist Ava Perkins.
It’s important to note that the warning letter pertains to the use of terms such as “mousse,” “foam,” and “whipped” in marketing language—a format descriptor. The warning letter does not point out any issues with the product’s formulation, safety, or efficacy.
According to Perkins, the FDA only allows sunscreens in certain forms after rigorous safety and efficacy vetting. “The concern isn’t necessarily that mousse or foam sunscreens are ineffective; it’s just that they haven’t gone through the vetting process as the current approved formats,” she told BeautyMatter.
Formats like oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder have historically been recognized as GRASE for sun protection without requiring product-specific approval. This is based on marketing data and supporting evidence collected before 1972, when the FDA reclassified sunscreen as an OTC drug.
“Successful SPF and UVA testing is a prerequisite for all sunscreens, but that does not override the form restriction,” said Mohammed Kanadil, a pharmacist, toxicologist, and cosmetic safety expert. “[The] FDA regards form as a standalone risk factor, as it changes the means by which consumers use the product and are exposed to the active ingredients.”
This, Kanadil explained, is the reason that products like sprays, while allowed, face stringent requirements regarding particle size and flammability. Foam products that bypass the formal review process are considered adulterated, even if they meet SPF performance standards.
Achieving dosage accuracy is a formulation challenge for these types of sunscreen products. This is one of the FDA’s main concerns, according to Perkins, and why the agency is acting so swiftly to get these products off the market.
“Mousses have a lot of air in the product after dispensing, so the volume is quite larger than the density,” said Perkins. “Even though it may look like a consumer is applying a substantial amount of product, the actual ‘sunscreen’ part is less than it looks.”
Testing of mousse and foam sunscreen formats must account for dosage to ensure consistent UV protection. Most “skintellectual” consumers are aware that adequate protection requires approximately three finger lengths of product or two milligrams per square centimeter of skin. With aerated formulations, such as mousse or foam, however, a larger amount may be necessary to achieve the labeled SPF.
“It would be interesting to view the SPF test reports [supporting] the SPF 50 broad-spectrum claim to see how the product was tested, how much was applied, and how often,” Kam Kaur, a global cosmetic regulatory expert, noted.
Another concern is the even distribution of UV filters within the foam structure, as well as its shelf stability.
“I don’t doubt that these companies did stability and safety testing, but I believe this may be a part of the concern the FDA has,” she added.
Blinded by Foam Sunscreen’s Frothy Hype
So, how did multiple brands overlook the fact that mousse is not an approved dosage form? It’s possible that either brands didn’t think to review the list of approved dosage forms, or the brands were aware of the regulations but decided to proceed anyway.
The FDA is clear about the requirements for OTC sunscreen products in the final order. “If one were to solely look at OTC Monograph M020 instead of the entire Final Administrative Order (OTC000006), they would have missed the section that explains the permitted product types,” said Perkins. “Additionally, it is possible that smaller brands without robust regulatory oversight saw that larger brands were doing it and wanted to follow suit.”
Innovation is often ahead of regulation. Today, technology enables formulators to create SPF mousses and foams, but this wasn’t always the case. The FDA issued a proposed rule for the SPF monograph in 1993, and the final monograph was published in 1999.
“Back then, we didn't have formulation innovations such as mousses and foams, so they were not purposely left out,” explained Kaur.
Some brands, Perkins speculated, might have been aware of the regulations but gambled on slow FDA enforcement. They likely hoped the product would achieve sales and brand recognition before the unapproved format was discovered, if it ever were. Supergoop! launched its mousse sunscreen back in 2017, while Vacation Inc. launched its version in 2022, so it took some time for the FDA to catch wind of the whipped sunscreen phenomenon.
“In a market where innovation is often driven by marketing, these requirements can overshadow regulatory or scientific input, with innovation choices often starting and ending at marketing meetings,” said Kanadil. “Experts may be bypassed or overridden in the bid to create something that appears different, and in an overcrowded market, this differentiation can be achieved, even if it stretches compliance boundaries.”
The Future of Mousse Sunscreens
Achieving FDA compliance for these mousses requires more than a simple reformulation. “[Brands can] keep the same formula and put it in different packaging, such as a spray or squeeze bottle, but then it loses its ‘foaminess,’ which was the whole point,” Perkins stated. “Or, they could continue with the texture-focused marketing and reformulate their sunscreens to be a fluffy, lightweight lotion or cream.”
Without the air-whipped texture and familiar packaging, these formulations wouldn’t be as appealing to consumers, who, at this point, are used to seeing SPF products as part skin protection, part novelty. Perkins predicted that most brands would likely withdraw mousse formats from the market or limit sales to regions where they are permitted. While adding mousse to the monograph is an option, it's a lengthy and expensive process.
“Some well-resourced brands might pursue it, but most will pivot to formats that can go to market faster,” she added.
According to Kaur, new drug applications can take years and cost millions of dollars, so it is likely these products will need to be withdrawn from the US market.
Beauty brands should take note of these warning letters to avoid future regulatory issues. Innovating for the sake of innovating is meaningless if the outcome isn’t approved by the FDA and able to be sold in the market.
“I think these warning letters may be a wake-up call for some, and it’s clear that the FDA is not playing,” shared Perkins. “It might be redundant to say, but if you want to sell sunscreen in the US, make sure you’re innovating within FDA regulations. If not, make sure you have a great legal team.”
Brands are ultimately responsible for ensuring full compliance with all relevant regulations before launching a new product. Perkins recommended that brands compare the SPF active ingredient list, dosage form, packaging, and claims against the FDA monograph prior to market release.
“Compliance must always be built into product development,” added Kaur. “The US OTC system isn't really built for brands wishing to innovate new product formats, as the FDA monographs are outdated and updating them can take years! This is what sets the US behind other markets such as the UK and EU, where innovation is welcomed and product formats such as these are adequately tested, not only for protection but also safety.”
For Kanadil, the FDA's warning letters serve as a reminder of the importance of investing in and heeding the advice of appropriate regulatory, safety, and technical experts throughout each stage of product development.
“Specialist input is restrictive on the creative process, but it is an indispensable sieve to decide what is legally permissible, physically practicable, and economically viable, reducing the risk of noncompliance, recall, or reputation damage,” he said.
“Regulations, especially in the US, where sunscreens are regulated as drugs, may appear strict but are set by regulation experts, toxicologists, and risk assessors to ensure that personal care products are safe and effective when used under real-life conditions.”
