federal_register: 99-12853

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
99-12853 Sunscreen Drug Products For Over-The-Counter Human Use; Final Monograph Rule The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) sunscreen drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on the agency's proposed regulation, which was issued in the form of a tentative final monograph, and new data and information on sunscreen drug products that have come to the agency's attention. FDA is also issuing final rules regarding the labeling of certain cosmetic products to inform consumers that these products do not provide protection from the sun. 1999-05-21 1999 5 https://www.federalregister.gov/documents/1999/05/21/99-12853/sunscreen-drug-products-for-over-the-counter-human-use-final-monograph https://www.govinfo.gov/content/pkg/FR-1999-05-21/pdf/99-12853.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) sunscreen drug products are generally recognized as safe and effective and not misbranded as part...

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