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Waxhead Sun Defense Company was cited for marketing its Waxhead Sun Defense Body Wash as an over-the-counter drug without proper FDA approval by making unsubstantiated sun protection claims on its website and product labeling. The company violated FDA regulations by claiming the product provides "UVA/UVB/UVC protection" and acts as a sunscreen alternative to protect skin and hair from sun damage, thereby establishing drug intent under the Federal Food, Drug, and Cosmetic Act. These marketing claims—including statements that the product "boosts daily UV protection" and "protects areas difficult to cover with sunscreen"—demonstrated the company's intent to market a drug product without meeting the approval requirements for over-the-counter sunscreen drugs.