Introduction to FDA Warnings on Mousse Sunscreens
The U.S. Food and Drug Administration has issued warning letters to five popular sunscreen brands over their mousse products. The federal regulator is also urging consumers not to use the foam-style products because they may not be effective in protecting the skin from the sun’s harmful UV rays.
Background on Sunscreen Regulations
Sunscreens are classified as over-the-counter drugs in the U.S. because they are intended to prevent sunburn and reduce the risk of skin cancer and premature skin aging. That categorization comes with strict regulations around how they’re formulated and marketed. The FDA notes that sunscreen formats approved in the U.S. include oil, lotion, cream, gel, butter, paste, ointment, stick, spray and powder. However, there is no current authorization of sunscreen in "foam, mousse or whip dosage form," and the makers of the mousse sunscreens did not receive specific agency authorization.
Affected Companies and Products
Among the companies that received the letter was popular brand Supergoop! over its Play SPF 50 Body Mousse. "At Supergoop! we remain committed to innovation in sun care and the highest standards of product efficacy and safety," the company said 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., which makes "Classic Whip Sunscreens" that is marketed as "dessert for your skin," also received a letter. The FDA said the products package, which resembles whipped cream cans, "can mislead consumers into mistaking the products for food, which is of particular concern as this increases the risk of accidental ingestion." The FDA also issued warning letters to K & Care Organics, which makes the Botao brand kids sunscreen and Sun & Shine products, as well as Kalani Sunwear and Fallien Cosmeceutical, which owns the brand TiZo, over their mousse sunscreen products.
FDA Warning and Potential Consequences
“Beware of sunscreen products in mousse form because they might not be effective," the FDA wrote in a post as they announced the warning letters sent to companies marketing the mousse-form products. The companies have 15 days to response to the FDA’s letter, laying out the steps it has taken to address any violations, or provide information on why it believes it is not in violation. If they fail to comply, the companies risk their products being possibly pulled from the market.
How Sunscreens Work
Mineral-based sunscreens mechanically block UVA/UVB rays, while chemical sunscreens absorb rays and turn them into heat. Understanding how sunscreens work is crucial in making informed decisions about which products to use, especially in light of the FDA’s warnings about mousse sunscreens.
Conclusion
The FDA’s warning about mousse sunscreens highlights the importance of adhering to regulatory standards in the production and marketing of sunscreen products. Consumers are advised to be cautious when using foam-style sunscreens and to opt for approved formats. The affected companies must respond to the FDA’s warnings and take necessary actions to comply with regulations, ensuring the safety and efficacy of their products.
FAQs
- Q: Why did the FDA issue warning letters to sunscreen brands?
A: The FDA issued warning letters because the mousse sunscreen products may not be effective in protecting the skin from the sun’s harmful UV rays and are not approved formats. - Q: Which companies received the FDA’s warning letters?
A: Supergoop!, Vacation Inc., K & Care Organics, Kalani Sunwear, and Fallien Cosmeceutical received the warning letters. - Q: What is the risk associated with mousse sunscreen packaging?
A: The packaging can mislead consumers into mistaking the products for food, increasing the risk of accidental ingestion. - Q: What happens if the companies fail to comply with the FDA’s warnings?
A: Their products may be pulled from the market if they fail to respond to the FDA’s letter or comply with regulatory requirements.
