FDA Issues Warning Letters to Several Sunscreen Brands

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, warning letters were issued to Supergoop!, Vacation Inc., Kalani Sunwear, Fallien Cosmeceuticals (TiZO brand) and K & Care Organics on August 6 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 noted 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.’”