{"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 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 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-OPEN"}],"document_number":"2019-03019","effective_on":null,"end_page":6275,"executive_order_notes":null,"executive_order_number":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":"84d1fc93fb70ef72c7c0e639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