FDA WARNING_LETTER - K & Care Organics - August 12, 2025

The FDA issued a warning letter on August 6, 2025, to Simtat Hadayagim 2 St, Mikhmoret, Israel, concerning their products marketed in the U.S. The inspection, conducted on May 14, 2025, identified significant regulatory violations related to the labeling and marketing of “BOTAÓ Kids Mineral Foam Spray,” “BOTAÓ Baby Mineral Foam Spray,” and “SUN & SHINE SPF 50+ BROAD SPECTRUM Mineral Sunscreen Mousse.”

These products are classified as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the prevention of sunburn, thus affecting the body"s structure or function. However, they lack FDA-approved applications as required under section 505 of the FD&C Act. Additionally, they do not comply with the conditions set forth in the applicable Over-the-Counter (OTC) monograph for sunscreen products, specifically because they are marketed in a foam form, which is not authorized under current regulations.

The FDA has deemed these products misbranded under section 502(ee) of the FD&C Act, making their introduction into interstate commerce a violation of section 301(a). The company is required to respond within 15 working days, detailing corrective actions taken to address these violations and prevent recurrence. Failure to comply may result in legal actions, including product seizure or injunction. The response should be directed to the FDA"s Office of Unapproved Drugs and Labeling Compliance, including the firm"s name and identifier “711000” in the correspondence.