The letters, dated August 6, 2025, were sent to Supergoop!, Vacation Inc., Kalani Sunwear, Fallien Cosmeceuticals, and K & Care Organics (BOTAÓ brand).
The warning letters, which were made publicly available on FDA’s website on August 12, emphasize that mousse and foam sunscreens cannot be sold in the U.S. without an approved application or final FDA order.
Regulatory basis for FDA action
According to the letters, mousse and foam sunscreens fall outside the dosage forms recognized as generally recognized as safe and effective (GRASE) under the OTC sunscreen monograph. Under section 505G(m)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act, these products require a final order or approved application before marketing.
The FDA wrote in multiple letters: “No final order has been issued by the Secretary under 505G(b) or 505G(c) that would authorize marketing of sunscreen in a foam (aka mousse) dosage form.”
Summary of warning letters
Supergoop!
FDA cited the company’s Body Mousse SPF 40 as a foam dosage form not covered by the final administrative order M020.
The letter stated: “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...[and] there is no FDA-approved application in effect for your drug product.”
Vacation Inc.
Vacation Inc.’s Whipped Sunscreen SPF 30 was similarly flagged. As previously reported by CosmeticsDesign US in a 2023 interview, the product was developed in collaboration with Clayton Corporation, whose technology was used to formulate Reddi-Whip whipped cream.
FDA wrote: “Your Whipped Sunscreen SPF 30 is misbranded under section 502(ee) of the FD&C Act because it is a foam dosage form that has not been authorized under a final order or approved application.”
Packaging is also at issue, according to FDA: “Furthermore, your ‘Classic Whip Sunscreens’ are misbranded under Section 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1), which provides that a drug is misbranded if ‘its container is so made, formed, or filled as to be misleading,’ because they are packaged in containers that resemble food canisters customarily purchased by U.S. consumers.”
Kalani Sunwear
The letter to Kalani AB dba Kalani Sunwear noted that the Hawaii Whip SPF 50 lacked required marketing authorization, as “no FDA-approved applications pursuant to section 505 of the FD&C Act are in effect for your drug product.”
Fallien Cosmeceuticals
Fallien Cosmeceuticals’ Solar Protective Mousse SPF 50+ was cited as an unapproved foam sunscreen. FDA stated: “Sunscreens in dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder require an approved application or final order prior to marketing.”
K & Care Organics (BOTAÓ)
The FDA’s letter addressed multiple foam and mousse products, including “BOTAÓ Kids Mineral Foam Spray” and “SUN & SHINE Sunscreen Mousse.”
The agency wrote: “‘BOTAÓ Kids Mineral Foam Spray,’ ‘BOTAÓ Baby Mineral Foam Spray,’ and ‘SUN & SHINE Sunscreen Mousse’ are misbranded under section 502(ee) of the FD&C Act” as unapproved delivery formats being marketed without proper FDA application submission.
Industry perspectives
The FDA warning letters underscore a regulatory gap for mousse and foam sunscreens. CDU spoke to Carl D’Ruiz, Head of NA Beauty & Care Science Advocacy and Business Development at dsm-firmenich, who noted that while some mousse formulations may meet safety standards, the dosage form itself remains unapproved.
He said the case “presents an opportunity to revisit and expand the scope of approved dosage forms, aligning innovation with modern formats that enhance consumer experience and compliance.” According to D’Ruiz, creating products that consumers enjoy using can support more consistent application, ultimately benefiting public health by helping prevent sunburn and skin damage.
Formulation challenges are another concern. Cosmetic chemist Kelly Dobos, MS, MBA, told CDU that mousse sunscreens “require precise control over rheology and stability” to ensure active ingredients like zinc oxide or avobenzone are evenly distributed.
She added that compliance is critical, emphasizing that “whether we agree with them or not, the rules are the rules. Running afoul of the rules can have serious consequences like product recalls or seizures.”
Safety considerations extend to packaging. Dermatologist Jane Yoo, M.D., spoke to CDU and highlighted that only certain dosage forms are considered GRASE.
She explained, “Only sunscreens in the form of oil, lotion, cream, gel, butter, paste, ointment, stick, spray and powder may be lawfully marketed… No final order has been issued by the FDA that would authorize marketing of a sunscreen in a foam (mousse/whip).”
Yoo also noted concerns about consumer safety, stating that products packaged like food could be mistaken for edible items: “The FDA wants to minimize the risk of accidental ingestions, especially by children.”
Taken together, the experts opined that while mousse and foam sunscreens may appeal to consumers, manufacturers must carefully balance innovation with regulatory compliance, formulation integrity, and safety considerations.
FDA informed the companies that they have 15 working days from receipt of each letter to respond with corrective actions, and noted that failure to comply could result in product seizure or injunction.
Company responses
CosmeticsDesign US contacted each of the brands that received a warning letter for comment.
In response to our request, a Supergoop! spokesperson explained that “At Supergoop! we remain committed to innovation in sun care and the highest standards of product efficacy and safety, [and] 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.”
The spokesperson added that “We are working closely with the FDA to resolve this matter as we continue to uphold the high standards our consumers expect from us.”
We also received a response to our request for comment from Anna Xavier, CEO and Partner of Kalani Sunwear. Xavier stated that “Kalani Sunwear can confirm that the recent FDA warning letter relates solely to the fact that, under U.S. regulations, SPF products are classified as drugs and therefore require prior registration before being offered for sale in the United States.”
She continued: “The letter does not state that mousse-format sunscreens are inherently less effective, nor does it raise any concerns regarding the safety, quality, or performance of our formulation, [and] following receipt of the letter, we immediately removed the product from our U.S. website to ensure full regulatory compliance.”
Further, she added, “our Sun Mousse SPF 50 is developed and manufactured in Sweden by one of Europe’s most respected sunscreen producers and meets or exceeds the strict safety and efficacy standards in place within the European Union.”
As “EU regulations require a significantly higher level of proven UVA protection compared to the U.S., and our formulation utilizes the most advanced UV filters currently available — filters which are not yet approved for use in the U.S., where the last new UV filter approval occurred in 1999,“ she concluded, ”we remain confident in the quality, safety and effectiveness of our product and appreciate you ensuring this context is reflected in your coverage."
At the time of publication, CosmeticsDesign US has not received a response to the request for comment from Vacation Inc., Fallien Cosmeceuticals, or K & Care Organics (BOTAÓ).
