The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Supergoop! after the Agency reviewed the Play SPF 50 Body Mousse label and website. The FDA concluded that the Body Mousse makes drug claims.

The FDA noted,

“Supergoop! PLAY SPF 50 BODY MOUSSE” is a ‘drug’ as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.”

Based on product labeling, the FDA concluded Supergoop! Play SPF 50 Body Mousse is intended for use as an over-the-counter (OTC) sunscreen drug product.

Labeling that supports this claim includes:

• “Broad Spectrum Sunscreen SPF 50” [from product label]
• “Helps prevent sunburn…” [from product label] 
• “A lightweight, whipped sunscreen mousse that’s water- & sweat-resistant…” [from product website]
• “This innovative SPF was created to be the perfect family-friendly sunscreen…a fun mousse texture…” [from product website]
• “Sunscreen innovation at its finest: lightweight, whipped, antioxidant-rich sunscreen mousse with SPF 50 protection…” [from Instagram social media page]

Supergoop! made an official comment below:

“At Supergoop! we remain committed to innovation in sun care and the highest standards of product efficacy and safety. 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.“

The full Warning Letter and more info can be found here.

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