The skin-health mantra to “wear sunscreen” still echoes loud and clear—but new warning letters from the FDA are putting some formulations under fire.
According to Cincinnati, OH cosmetic chemist Kelly Dobos, on August 6, warning letters were issued to Supergoop!, Vacation Inc., Kalani Sunwear, Fallien Cosmeceuticals (TiZO brand) and K & Care Organics for unapproved dosage forms.
“The FDA noted that, according to Over-the-Counter Monograph M020, sunscreens in dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder may only be lawfully marketed with an approved new drug application,” Dobos says, explaining that the FDA requires any dosage form to have sufficient data demonstrating safety and effectiveness.
“The FDA is likely concerned that mousse or foam may not provide adequate coverage, which is critical to effective sun protection,” she says. “The brands should have done the appropriate testing to make label claims—but that’s not sufficient for the FDA if the dosage form isn’t already listed in the rules. A new drug application would be needed for any novel dosage form that isn’t listed.”
The FDA also noted that 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,” Dobos adds.
Specifically referenced in the letters: “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.'”
“This could mean Vacation’s whipped sunscreen could be pulled from the market,” says Dobos. “Per the warning letters, ‘failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.'”
What this means for a consumer: “The FDA’s recent warning letters make it clear that mousse, foam and whipped sunscreens are not currently recognized as approved sunscreen formats in the U.S,” says Dallas dermatologist Elizabeth Houshmand, MD. “This doesn’t mean these products are unsafe—it means their unique texture falls outside the FDA’s list of pre-approved sunscreen forms, so brands would need additional regulatory clearance to keep selling them.”
The most important thing is to continue using a broad-spectrum sunscreen, Dr. Houshman stresses, but stick to an approved form: “l lotion, cream, gel, stick, spray, or powder daily,” she says. “I like an SPF of 50 and layer my sunscreens, but there are so many highly efficacious and cosmetically available options out there. If you love the sensorial experience of a mousse or whipped sunscreens, these may become harder to find until companies complete the approval process.”
