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Medscape
5 hours ago
- Health
- Medscape
FDA Warns About ‘Mousse' Sunscreens
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.'
CBS News
7 days ago
- Health
- CBS News
Supergoop! and other mousse sunscreen products may not work, FDA warns
Popular sunscreen products that come in mousse form, such as Supergoop!'s body mousse, may not protect wearers from the sun's harmful UV rays, the U.S. Food and Drug Administration is warning. "Beware of sunscreen products in mousse form because they might not be effective," the FDA said in a post on X after issuing five warning letters to companies that make these types of sunscreens. Additionally, the products can pose a risk to consumers because they are packaged to resemble whipped cream containers, which raises the risk that someone could mistake them for food and ingest them, the FDA said. One warning letter was sent to Vacation Inc., a personal care startup that makes what the company calls "Classic Whip Sunscreens," which it markets as "dessert for your skin." The products are classified as drugs because they are designed to, and marketed as, products that can help prevent sunburn and decrease the risk of skin cancer, the FDA notes. While they are sold as over-the-counter drugs, they have not received the required FDA approval, according to the agency's letter. "There are no FDA-approved applications in effect for your drug products," the letter states. The products are also "misbranded" as they are packaged in containers that resemble food canisters, according to the FDA. "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 letter reads. Vacation did not immediately respond to a request for comment. Supergoop!, a popular personal care company, also received an FDA warning letter, which informs companies that they have 15 days to address any violations the agency has identified. Supergoop! did not immediately respond to CBS News' request for comment. Supergoop!'s "Play SPF 50 Body Mousse" sunscreen product, also an over-the-counter drug product, lacks FDA approval and violates marketing regulations, according to the letter. Other companies that make mousse sunscreen products, and which received FDA warning letters, include Kalani Sunwear, Botao Baby and Tizo Skin, which also make mousse sunscreen products. None of the companies have responded to CBS News' inquiry about the FDA's warnings.
