Kabana Skin Care – FDA Warning Letter, Mar 18, 2025

On March 12, 2025, the FDA issued a Warning Letter to Mr. Kreider regarding the "Kabana Body Wash +UV" product sold on kabanaskincare.com. The FDA's review in June 2024 found the product to be an unapproved new drug and misbranded.

The "Kabana Body Wash +UV" is considered a drug under section 201(g)(1)(B) and (C) of the FD&C Act due to claims indicating its use as an OTC sunscreen. No FDA-approved application exists for this product under section 505(a) of the FD&C Act.

The product is misbranded under section 502(ee) of the FD&C Act because it does not comply with section 505G, which governs nonprescription drugs marketed without an approved application. While OTC sunscreens are generally recognized as safe and effective (GRASE) if they conform to the M020 monograph, the "Kabana Body Wash +UV" is a body wash dosage form. Section 505G(m)(2) specifies that sunscreens in dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder require an order issued under section 505G to be lawfully marketed without a 505-approved application. No such order has been issued