{"abstract":"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.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/1999/05/21/99-12853.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"310","title":21},{"chapter":null,"citation_url":null,"part":"352","title":21},{"chapter":null,"citation_url":null,"part":"700","title":21},{"chapter":null,"citation_url":null,"part":"740","title":21}],"citation":"64 FR 27666","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This regulation is effective May 21, 2001 for parts 310, 352, and 700 and is effective May 22, 2000 for part 740.","disposition_notes":null,"docket_ids":["Docket No. 78N-0038"],"dockets":[],"document_number":"99-12853","effective_on":"2001-05-21","end_page":27693,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1999/05/21/99-12853/sunscreen-drug-products-for-over-the-counter-human-use-final-monograph","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/99-12853?publication_date=1999-05-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1999-05-21/99-12853/mods.xml","not_received_for_publication":null,"page_length":28,"page_views":{"count":2033,"last_updated":"2026-10-23 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1999-05-21/pdf/99-12853.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1999-05-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1999/05/21/99-12853.txt","regulation_id_number_info":{"0910-AA01":{"issue":"200310","html_url":"https://www.federalregister.gov/regulations/0910-AA01/over-the-counter-otc-drug-review","title":"Over-the-Counter (OTC) Drug Review","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=200310&RIN=0910-AA01&operation=OPERATION_EXPORT_XML","priority_category":"Routine and Frequent"}},"regulation_id_numbers":["0910-AA01"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 208 - Kasichayanula_2005_Simultaneous Analysis of Insect Repellent DEET, Sunscreen Oxybenzone and Five Relevant Metabolites","document_id":"FDA-1978-N-0018-1049"},{"title":"Reference 196 - FDA_Food Additive Status List","document_id":"FDA-1978-N-0018-1037"},{"title":"Reference 193 - Katz_2008_Insect Repellants- Historical Perspectives and New Developments","document_id":"FDA-1978-N-0018-1034"},{"title":"Reference 190 - EPA_Using Insect Repellents Safely and Effectively","document_id":"FDA-1978-N-0018-1031"},{"title":"Reference 180 - TGA_2016_Australian regulatory guidelines for sunscreens","document_id":"FDA-1978-N-0018-1021"},{"title":"Reference 169 - Damian_2011_An action spectrum for UV radiation-induced immunosuppression in humans","document_id":"FDA-1978-N-0018-1010"},{"title":"Reference 153 - Liu_2017_Particle Size Distribution Analysis of OTC Drug Products with Unintended Inhalation Exposure to Consumers","document_id":"FDA-1978-N-0018-0994"},{"title":"Reference 148 - Stuart_1984_Deposition and Clearance of Inhaled Particles","document_id":"FDA-1978-N-0018-0989"},{"title":"Reference 134 - Rodriguez_2006_Causal agents of photoallergic contact dermatitis","document_id":"FDA-1978-N-0018-0975"},{"title":"Reference 99 - Gupta_1999_Percutaneous Absorption of Sunscreens through Micro-Yucatan Pig Skin in Vitro","document_id":"FDA-1978-N-0018-0939"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AF43/sunscreen-drug-products-for-over-the-counter-human-use-final-monograph-","title":"Sunscreen Drug Products For Over-The-Counter-Human Use; Final Monograph\n"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-1978-N-0018","supporting_documents_count":325,"docket_id":"FDA-1978-N-0018","regulation_id_number":"0910-AF43","title":"Sunscreen Drug Products -OPEN","checked_regulationsdotgov_at":"2019-08-04T02:30:07Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":27666,"subtype":null,"title":"Sunscreen Drug Products For Over-The-Counter Human Use; Final Monograph","toc_doc":null,"toc_subject":null,"topics":[],"type":"Rule","volume":64}