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Talk to a SpecialistTalk to a SpecialistFallien Cosmeceuticals Ltd. was cited for marketing TiZO® SHEERFOAM™ SPF 30 as an unapproved over-the-counter drug product without required FDA approval under section 505 of the FD&C Act. The company's product labeling, website, and social media pages (Instagram and Facebook) made drug claims including "helps prevent sunburn" and references to "photo-protective performance" and "physical broad spectrum protection," establishing the product's intended use as a drug requiring FDA approval. The sunscreen was being sold directly to consumers without a prescription through the company's website at tizoskin.com despite lacking the required new drug application approval.