{"abstract":"The Food and Drug Administration (FDA) is proposing to limit the maximum labeled SPF value for over-the-counter (OTC) sunscreen drug products to \"50+.\" We are issuing this proposed rule after reviewing data and information we received on the safety and effectiveness of OTC sunscreen drug products after publication of our 2007 proposed rule. The record does not currently contain sufficient data to indicate that there is additional clinical benefit above SPF 50. This proposal is part of FDA's ongoing review of these products to ensure their safety and effectiveness.","action":"Proposed 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/2011/06/17/2011-14769.html","cfr_references":[{"chapter":null,"citation_url":null,"part":201,"title":21}],"citation":"76 FR 35672","comment_url":null,"comments_close_on":"2011-09-15","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by September 15, 2011. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by July 18, 2011, (see the \"Paperwork Reduction Act of 1995\" section of this document). See section VII of this document for the proposed effective date of a final rule based on this proposal.","disposition_notes":null,"docket_ids":["Docket No. FDA-1978-N-0018","formerly Docket No. 1978N-0038"],"dockets":[],"document_number":"2011-14769","effective_on":null,"end_page":35678,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/06/17/2011-14769.xml","html_url":"https://www.federalregister.gov/documents/2011/06/17/2011-14769/revised-effectiveness-determination-sunscreen-drug-products-for-over-the-counter-human-use","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-14769?publication_date=2011-06-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-06-17/2011-14769/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":1144,"last_updated":"2026-08-25 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-06-17/pdf/2011-14769.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2011-06-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/06/17/2011-14769.txt","regulation_id_number_info":{"0910-AF43":{"issue":"201910","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","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201910&RIN=0910-AF43&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"}},"regulation_id_numbers":["0910-AF43"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 210 - Yiin_2015_Assessment of Dermal Absorption of DEET-Containing Insect Repellent and Oxybenzone-Containing Sunscreen","document_id":"FDA-1978-N-0018-1051"},{"title":"Reference 190 - EPA_Using Insect Repellents Safely and Effectively","document_id":"FDA-1978-N-0018-1031"},{"title":"Reference 185 - Kong_2015_Assessment of Consumer Knowledge of New Sunscreen Labels","document_id":"FDA-1978-N-0018-1026"},{"title":"Reference 180 - TGA_2016_Australian regulatory guidelines for sunscreens","document_id":"FDA-1978-N-0018-1021"},{"title":"Reference 179 - Fourtanier_2008_Sunscreens containing the BS UVA absorber prevent cutaneous detrimental effects of UV exposure","document_id":"FDA-1978-N-0018-1020"},{"title":"Reference 169 - Damian_2011_An action spectrum for UV radiation-induced immunosuppression in humans","document_id":"FDA-1978-N-0018-1010"},{"title":"Reference 154 - Liu_2018_Particle Size Distribution Analysis of OTC Aerosol or Powder Drug Products with Potential for Inhalation Exposure","document_id":"FDA-1978-N-0018-1004"},{"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 152 - Brown_2013_Thoracic and Respirable Particle Definitions for Human Health Risk Assessment","document_id":"FDA-1978-N-0018-0993"},{"title":"Reference 148 - Stuart_1984_Deposition and Clearance of Inhaled Particles","document_id":"FDA-1978-N-0018-0989"}],"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":"2011-07-07T08:07:56Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":35672,"subtype":null,"title":"Revised Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use","toc_doc":"Sunscreen Drug Products for Over-the-Counter Human Use; Revised Effectiveness Determinations","toc_subject":null,"topics":["Drugs","Labeling","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":76}