FDA WARNING_LETTER - Waxhead Sun Defense Company - March 18, 2025

On March 12, 2025, the FDA issued a Warning Letter to Mr. and Mrs. Kenner regarding their "Waxhead SUN DEFENSE SHAMPOO + CONDITIONER + BODY WASH + UV PROTECTION SUN DEFENSE BODY WASH with zinc oxide" product, sold on gowaxhead.com. The FDA's May 2024 review of product labeling determined the "Waxhead Sun Defense Body Wash" is an unapproved new drug, misbranded under sections 201(g)(1)(B) and 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(B) and (C), due to its intended use as an OTC sunscreen.

The product lacks an FDA-approved application under section 505 of the FD&C Act. While OTC sunscreens can be marketed under section 505G if they conform to the M020 monograph, the "Waxhead Sun Defense Body Wash" is a shampoo/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 for lawful marketing without an approved application. No such order exists for shampoo or body wash sun