Facing the high temperatures and UV rays of summer, sun protection has become crucial, with a plethora of sunscreen products flooding the market. However, the U.S. Food and Drug Administration (FDA) recently advised the public against using “mousse” type sunscreens.
According to the Food, Drug, and Cosmetic Act, sunscreen products are not approved for sale in mousse form. Last Tuesday (August 12th), the FDA took to social media to caution American consumers to be careful with mousse sunscreen products, as they may not be as effective.
The FDA issued warning letters to five companies selling sunscreen products on August 6th. These companies include Supergoop from Texas, Fallien Cosmeceuticals Ltd. from Pennsylvania, KCare Organics from Israel, Kalani AB from Sweden, and Vacation Inc. from Florida.
The FDA emphasized that the sunscreen products sold by these companies are considered drugs. According to section 505 of the Food, Drug, and Cosmetic Act, sunscreen products can only be approved for sale in forms such as oils, lotions, creams, gels, milks, ointments, sticks, sprays, or powders, excluding mousse and foam forms.
Specific products from these companies were flagged by the FDA, including Supergoop’s Body Mousse (Supergoop Play SPF 50 Body Mousse), Fallien’s Non-Tinted Mineral Sunscreen (Fallien TiZOs Sheerfoam Non-Tinted SPF 30 Mineral Sunscreen), K Care’s Kids Mineral Foam Spray (K Care Botao Grow Naturally Kids Mineral Foam Spray), Kalani Sunwear’s Sun Mousse (Kalani Sunwear Sun Mousse), and Vacation’s Classic Whip Broad Sunscreen Mousse (Vacation Classic Whip Broad Sunscreen Mousse).
The FDA also warned Vacation Inc. from Florida regarding the packaging of their sunscreen products, stating that the packaging resembled “metal cans used to package whipped cream and dessert toppings.”
The letter stated, “If the packaging of drugs looks like common food packaging for adults or children, consumers may mistake it for food, which is very dangerous and can lead to accidental ingestion.” The FDA requested the aforementioned companies to address these violations within 15 working days.
English Epoch Times reached out to these companies for comments. A spokesperson for Supergoop stated in an email to Epoch Times that the FDA’s notice “primarily focuses on product labeling issues, unrelated to the safety, efficacy, or formulation of the products,” and they are closely working with the FDA to resolve the matter while maintaining high standards expected by consumers.
Anna Xavier, CEO of Kalani AB, told Epoch Times that the FDA’s warning letter is “solely related to regulatory requirements in the United States.” She mentioned that SPF sunscreens are categorized as over-the-counter drugs in the U.S., requiring FDA registration for sale.
“The FDA letter does not question the safety, quality, or efficacy of our mousse sunscreen,” she added. “We are confident in the safety and effectiveness of our products.”
A spokesperson for Vacation Inc. also expressed confidence in the safety, efficacy, and quality of their products, pledging to work closely with the FDA to address the matter.
Epoch Times also contacted Fallien Cosmeceuticals and KCare Organics for comments.
According to a social media post by the FDA in August 2024, the agency’s regulatory approach to sunscreen is similar to other over-the-counter drugs, aiming to “ensure compliance with safety and efficacy standards.”
For instance, the FDA recalled three batches of Banana Boat sunscreen in 2022 due to benzene contamination. Testing revealed trace amounts of benzene in those products at the time.
Benzene is a chemical commonly used in manufacturing industrial products such as chemicals and dyes, and can be found in products like sunscreen. The agency stated that long-term inhalation or absorption of benzene through the skin could potentially lead to cancer or blood disorders.
According to a statement by the Environmental Working Group (EWG) on May 20, 2023, many sunscreens fail to provide the expected protection. The organization evaluated 2,204 sunscreens, finding that over 77% of products performed poorly in skin protection or contained potentially harmful ingredients.
David Andrews, Acting Chief Scientist at EWG, said, “Applying any brand of sunscreen is better than not using one, but not all sunscreens provide the same level of protection.”
On the other hand, 63 sunscreen products from 13 brands have received EWG certification, which is only awarded to products meeting high standards.
EWG noted a significant shift in the sunscreen market towards increasing demand for mineral products containing zinc oxide and titanium dioxide. These minerals can protect against UV rays and are the only active sunscreen filters generally recognized as safe and effective by the FDA.