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K & Care Organics was cited for marketing three sunscreen products—BOTAÓ Kids Mineral Foam Spray, BOTAÓ Baby Mineral Foam Spray, and SUN & SHINE SPF 50+ Broad Spectrum Mineral Sunscreen Mousse—as unapproved new drugs and misbranded products. The company violated FDA regulations by making drug claims (such as "helps prevent sunburn" and describing broad-spectrum UV protection) on product labeling and its website without obtaining FDA approval for these over-the-counter drug products. The products were distributed in the United States without meeting the regulatory requirements for OTC sunscreen drugs under 21 CFR Part 201 and the FD&C Act.