Loading…
CoLabs Intl. Corp was cited for marketing "KLĒNSKIN WASH ON SUNSCREEN" as an over-the-counter drug product without FDA approval. The company made drug claims on its website and product labeling stating the product provides broad-spectrum SPF 30 sun protection and is clinically proven, which established the product's intended use as a sunscreen drug under the Federal Food, Drug, and Cosmetic Act. The product was being sold without an approved New Drug Application (NDA) or compliance with Section 505G requirements for nonprescription drugs, violating FDA regulations governing unapproved drug marketing.