FDA Warns Supergoop! Over Misbranded Sunscreen Mousse

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Supergoop! regarding its PLAY SPF 50 Body Mousse, citing violations of federal law. The agency stated that the sunscreen, marketed as a broad-spectrum SPF 50 product, is considered a misbranded over-the-counter (OTC) drug.

According to the FDA, the mousse dosage form does not fall within the approved categories outlined under the OTC sunscreen monograph (M020) and therefore cannot be marketed without an approved new drug application. While traditional lotions, sprays, and sticks are permitted, sunscreens in mousse or foam forms currently lack authorization for sale without specific regulatory clearance.

The FDA emphasized that introducing misbranded drugs into interstate commerce violates the Federal Food, Drug, and Cosmetic Act. Supergoop! has been directed to provide corrective action within 15 working days. The move highlights ongoing scrutiny of sunscreen innovations, signaling that beauty companies must ensure compliance with FDA frameworks when introducing new dosage formats.

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