FDA WARNING_LETTER - CoLabs Intl. Corp - March 18, 2025

On March 12, 2025, the FDA issued a Warning Letter to Dr. Cohen regarding the "KLĒNSKIN WASH ON SUNSCREEN" drug product, available on klenskin.com. The FDA's May 2024 review of product labeling determined the product is a "drug" under section 201(g)(1)(B) and (C) of the FD&C Act due to its intended use as an OTC sunscreen.

The primary violation is that no FDA-approved application under section 505 of the FD&C Act is in effect for this drug product. While OTC sunscreens can be marketed under section 505G if they conform to the applicable OTC monograph (M020), the "KLĒNSKIN WASH ON SUNSCREEN" is in a shampoo or face/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 or an approved application. No such order has been issued for shampoo or face/body wash sunscreen dosage forms.

Consequently, the product is deemed a misbranded drug under sections 502(ee) and 301(a) of the FD&C Act. The FDA requires a written response within 15