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Vacation Inc. was cited for marketing sunscreen mousse products as unapproved new drugs and misbranded OTC drugs without proper FDA approval. The company's product labeling, website, and Instagram social media made disease prevention and health-related claims—including statements that the sunscreens "help prevent sunburn" and "decrease the risk of skin cancer and early skin aging"—which classified the products as drugs under the FD&C Act but were marketed without the required new drug application or compliance with OTC drug monograph requirements. The FDA inspection on March 5, 2025 identified these intended uses as violations of 21 U.S.C. 321(g)(1)(B) and (C), establishing that the products' marketing claims went beyond cosmetic purposes and required regulatory approval before distribution.