{"abstract":"The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. This proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. It is being published as part of the ongoing review of OTC drug products conducted by FDA. It is also being published to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Sunscreen Innovation Act (SIA).","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/2019/02/26/2019-03019.html","cfr_references":[{"chapter":null,"citation_url":null,"part":201,"title":21},{"chapter":null,"citation_url":null,"part":310,"title":21},{"chapter":null,"citation_url":null,"part":347,"title":21},{"chapter":null,"citation_url":null,"part":352,"title":21}],"citation":"84 FR 6204","comment_url":null,"comments_close_on":"2019-05-28","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments. on the proposed rule by May 28, 2019. Electronic comments must be submitted on or before May 28, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of May 28, 2019. See section XII for proposed effective and compliance dates of a final rule based on this document.","disposition_notes":null,"docket_ids":["Docket No. FDA-1978-N-0018"],"dockets":[{"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 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-OPEN"}],"document_number":"2019-03019","effective_on":null,"end_page":6275,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/02/26/2019-03019.xml","html_url":"https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use","images":{"EP26FE19.010":{"large":"https://img.federalregister.gov/EP26FE19.010/EP26FE19.010_large.png","original_size":"https://img.federalregister.gov/EP26FE19.010/EP26FE19.010_original_size.png"},"EP26FE19.007":{"large":"https://img.federalregister.gov/EP26FE19.007/EP26FE19.007_large.png","original_size":"https://img.federalregister.gov/EP26FE19.007/EP26FE19.007_original_size.png"},"EP26FE19.006":{"large":"https://img.federalregister.gov/EP26FE19.006/EP26FE19.006_large.png","original_size":"https://img.federalregister.gov/EP26FE19.006/EP26FE19.006_original_size.png"},"EP26FE19.005":{"large":"https://img.federalregister.gov/EP26FE19.005/EP26FE19.005_large.png","original_size":"https://img.federalregister.gov/EP26FE19.005/EP26FE19.005_original_size.png"},"EP26FE19.004":{"large":"https://img.federalregister.gov/EP26FE19.004/EP26FE19.004_large.png","original_size":"https://img.federalregister.gov/EP26FE19.004/EP26FE19.004_original_size.png"},"EP26FE19.003":{"large":"https://img.federalregister.gov/EP26FE19.003/EP26FE19.003_large.png","original_size":"https://img.federalregister.gov/EP26FE19.003/EP26FE19.003_original_size.png"},"EP26FE19.014":{"large":"https://img.federalregister.gov/EP26FE19.014/EP26FE19.014_large.png","original_size":"https://img.federalregister.gov/EP26FE19.014/EP26FE19.014_original_size.png"},"EP26FE19.002":{"large":"https://img.federalregister.gov/EP26FE19.002/EP26FE19.002_large.png","original_size":"https://img.federalregister.gov/EP26FE19.002/EP26FE19.002_original_size.png"},"EP26FE19.013":{"large":"https://img.federalregister.gov/EP26FE19.013/EP26FE19.013_large.png","original_size":"https://img.federalregister.gov/EP26FE19.013/EP26FE19.013_original_size.png"},"EP26FE19.001":{"large":"https://img.federalregister.gov/EP26FE19.001/EP26FE19.001_large.png","original_size":"https://img.federalregister.gov/EP26FE19.001/EP26FE19.001_original_size.png"},"EP26FE19.012":{"large":"https://img.federalregister.gov/EP26FE19.012/EP26FE19.012_large.png","original_size":"https://img.federalregister.gov/EP26FE19.012/EP26FE19.012_original_size.png"},"EP26FE19.000":{"large":"https://img.federalregister.gov/EP26FE19.000/EP26FE19.000_large.png","original_size":"https://img.federalregister.gov/EP26FE19.000/EP26FE19.000_original_size.png"},"EP26FE19.011":{"large":"https://img.federalregister.gov/EP26FE19.011/EP26FE19.011_large.png","original_size":"https://img.federalregister.gov/EP26FE19.011/EP26FE19.011_original_size.png"},"EP26FE19.009":{"large":"https://img.federalregister.gov/EP26FE19.009/EP26FE19.009_large.png","original_size":"https://img.federalregister.gov/EP26FE19.009/EP26FE19.009_original_size.png"},"EP26FE19.008":{"large":"https://img.federalregister.gov/EP26FE19.008/EP26FE19.008_large.png","original_size":"https://img.federalregister.gov/EP26FE19.008/EP26FE19.008_original_size.png"}},"images_metadata":{"EP26FE19.010":{"large":{"identifier":"EP26FE19.010","content_type":"image/png","size":463,"width":49,"sha":"dc328b44f77609786daab1d7f152563c","url":"https://img.federalregister.gov/EP26FE19.010/EP26FE19.010_large.png","height":25},"original_size":{"identifier":"EP26FE19.010","content_type":"image/png","size":352,"width":87,"sha":"6b4f89ceddd0eee4e40a8fa561955cfb","url":"https://img.federalregister.gov/EP26FE19.010/EP26FE19.010_original_size.png","height":45}},"EP26FE19.007":{"large":{"identifier":"EP26FE19.007","content_type":"image/png","size":862,"width":96,"sha":"20e133d739a378902861ec892272c934","url":"https://img.federalregister.gov/EP26FE19.007/EP26FE19.007_large.png","height":26},"original_size":{"identifier":"EP26FE19.007","content_type":"image/png","size":599,"width":169,"sha":"61dbd9a138277777cbe6da8104357bf1","url":"https://img.federalregister.gov/EP26FE19.007/EP26FE19.007_original_size.png","height":45}},"EP26FE19.006":{"large":{"identifier":"EP26FE19.006","content_type":"image/png","size":1810,"width":220,"sha":"b0f7446849828d57b1a353072f6359e8","url":"https://img.federalregister.gov/EP26FE19.006/EP26FE19.006_large.png","height":59},"original_size":{"identifier":"EP26FE19.006","content_type":"image/png","size":904,"width":393,"sha":"2f4e90911b5aaeccd5c0af80cbeae3f6","url":"https://img.federalregister.gov/EP26FE19.006/EP26FE19.006_original_size.png","height":105}},"EP26FE19.005":{"large":{"identifier":"EP26FE19.005","content_type":"image/png","size":15575,"width":683,"sha":"f2c07e54d9a61ab1e7f8bb99190fb799","url":"https://img.federalregister.gov/EP26FE19.005/EP26FE19.005_large.png","height":131},"original_size":{"identifier":"EP26FE19.005","content_type":"image/png","size":8587,"width":1225,"sha":"84d1f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Monograph\n"},"comments_count":1001,"agency_id":"FDA","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","document_id":"FDA-1978-N-0018-0841","regulation_id_number":"0910-AF43","title":"Sunscreen Drug Products -OPEN","checked_regulationsdotgov_at":"2023-02-28T23:26:01Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":6204,"subtype":null,"title":"Sunscreen Drug Products for Over-the-Counter Human Use","toc_doc":"Sunscreen Drug Products for Over-the-Counter Human Use","toc_subject":null,"topics":["Administrative practice and procedure","Drugs","Incorporation by reference","Labeling","Medical devices","Over-the-counter drugs","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":84}