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Kabana Skin Care was cited for marketing "Kabana Body Wash +UV" as an unapproved new drug in violation of section 505(a) of the FD&C Act and for misbranding under section 502(ee). The company made drug claims on its website and product labeling characterizing the product as providing UV protection and sun defense, which caused the over-the-counter body wash to be regulated as a drug rather than a cosmetic without obtaining required FDA approval. The FDA identified these violations during a June 2024 review of the company's website and product labeling.