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Kalani AB was cited for marketing "Kalani sunwear SUN MOUSSE SPF 50" as an unapproved new drug and misbranded product without proper FDA approval. The company made drug claims on its website, Instagram, and Facebook pages—including statements about "protection against harmful UV rays," "broad-spectrum formula," and preventing sunburns—that established the product's intended use as a drug under the Federal Food, Drug, and Cosmetic Act, yet the product was being sold without the required new drug application or compliance with OTC drug regulations. The FDA reviewed the product labeling and social media marketing on May 7, 2025, and determined the company had failed to obtain appropriate drug approval before distributing the product in the United States.