The US Food and Drug Administration (FDA) has issued warning letters to personal care brands amid claims that sun care products in mousse, foam and whipped form may not protect wearers from UV rays.
Letters were issued to Supergoop!, Vacation Inc., Kalani Sunwear, Fallien Cosmeceuticals, and K & Care Organics on 6 August for unapproved dosage forms.
In the case of Supergoop!, the FDA said that its Play SPF 50 Body Mousse product is misbranded as a product available for purchase in the US without a prescription.
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.
“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”, it added.
The FDA has ordered Supergoop! 15 working days from receipt of the letter to outline steps taken to correct any violations of federal law.
The FDA posted on X that mousse sunscreen products may not protect wearers from the sun.
“Beware of sunscreen products in mousse form because they might not be effective,” it said.
“Some mousse sunscreen products resemble whipped cream containers and may put consumers at risk if ingested,” it added.
University of Cincinnati cosmetic chemist and consultant Kelly Dobos posted on LinkedIn: “Given the dynamics of foam, it would be important to show consistent delivery of actives and in the case of ZnO (TiZO brand), I think it could be really challenging to ensure consistent dispersion and delivery.”
