FDA WARNING_LETTER - Fallien Cosmeceuticals Ltd. dba Fallene Ltd. - May 14, 2025

The FDA issued a warning letter to Dr. Fallick of TiZO Skin, located at 2541 General Armistead Ave, Norristown, PA, on August 6, 2025, following a review conducted on May 14, 2025. The review focused on the labeling and marketing of TiZO® SHEERFOAM™ SPF 30, a non-tinted mineral sunscreen available for purchase online and through social media channels. The product is classified as a drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it is intended for the prevention of sunburn, thus affecting the body"s structure or function.

The main issue identified is that TiZO® SHEERFOAM™ SPF 30 is marketed as an over-the-counter (OTC) sunscreen drug product without an FDA-approved application, as required under section 505 of the FD&C Act. The product does not conform to the conditions set forth in the applicable OTC monograph for sunscreens, as it is marketed in a foam dosage form, which is not authorized for OTC marketing without a specific FDA order. Consequently, the product is considered misbranded under section 502(ee) of the FD&C Act.

The FDA requires TiZO Skin to address these violations by submitting a written response within 15 working days, detailing the corrective actions taken to comply with federal regulations. Failure to adequately resolve these issues may result in legal actions, including product seizure and injunction. The response should be directed to the Office of Unapproved Drugs and Labeling Compliance, with the unique identifier “711006” included in the subject line.