{"abstract":"The Food and Drug Administration (FDA or the Agency) is issuing a proposed sunscreen order (proposed order) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA). The proposed order announces FDA's tentative determination that ecamsule (also known as terephthalylidene dicamphor sulfonic acid) at concentrations up to 10 percent is not generally recognized as safe and effective (GRASE) and is misbranded when used in over-the-counter (OTC) sunscreen products because the currently available data are insufficient to classify it as GRASE and not misbranded, and additional information is needed to allow us to determine otherwise.","action":"Proposed order; request for comments.","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/2015/02/25/2015-03883.html","cfr_references":[{"chapter":null,"citation_url":null,"part":310,"title":21}],"citation":"80 FR 10035","comment_url":null,"comments_close_on":"2015-04-13","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this proposed order by April 13, 2015. Sponsors may submit written requests for a meeting with FDA to discuss this proposed order by March 27, 2015. See section VI for the proposed effective date of a final order based on this proposed order.","disposition_notes":null,"docket_ids":["Docket No. FDA-2008-N-0474"],"dockets":[{"supporting_documents":[{"title":"Reference 10 - International Conference on Harmonization (ICH) Guideline for Industry, Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies S3A, March 1995","document_id":"FDA-2008-N-0474-0028"},{"title":"Reference 9 - International Conference on Harmonization (ICH)  Harmonized Tripartite Guideline for Industry Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(R2), 2005","document_id":"FDA-2008-N-0474-0027"},{"title":"Reference 8 - International Conference on Harmonization (ICH) Guidance for Industry - S1C(R2) Dose Selection for Carcinogenicity Studies (Revision 1), September 2008","document_id":"FDA-2008-N-0474-0026"},{"title":"Reference 7 - International Conference on Harmonization (ICH) Guidance for Industry, S1B Testing for Carcinogenicity of Pharmaceuticals, July 1997","document_id":"FDA-2008-N-0474-0025"},{"title":"Reference 6 - International Conference on Harmonization (ICH), Guidance for Industry, The Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals S1A, March 1996","document_id":"FDA-2008-N-0474-0024"},{"title":"Reference 5 - FDA Guidance for Industry, Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application, February 1987","document_id":"FDA-2008-N-0474-0023"},{"title":"Reference 4 - Schmidt et al, Photoallergic Contact Dermatitis Due to Combined UVB (4-Methylbenzylidene Camphor/Octyl Methoxycinnamate) and UVA (Benzophenone-3/Butyl Methoxydibenzoylmethane) Absorber Sensitization","document_id":"FDA-2008-N-0474-0022"},{"title":"Reference 3 - Schauder et al, Contact and Photocontact Sensitivity to Sunscreens. Review of a 15-Year Experience and of the Literature","document_id":"FDA-2008-N-0474-0021"},{"title":"Reference 2 - Leonard et al, The New Standard Battery of Photopatch Test in France.","document_id":"FDA-2008-N-0474-0020"},{"title":"Reference 1 - FDA, Guidance for Industry, Photosafety Testing, May 2003","document_id":"FDA-2008-N-0474-0019"}],"agency_name":null,"documents":[{"comment_count":8,"comment_start_date":"2015-02-25","updated_at":"2023-03-01T00:10:41.894-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2008-N-0474-0018","allow_late_comments":null,"id":"FDA-2008-N-0474-0018","comment_end_date":"2015-04-14","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":25,"id":"FDA-2008-N-0474","title":"Ecamsule Eligibility for Inclusion in Monograph; Over-the-Counter Sunscreen Drug Products for Human Use"}],"document_number":"2015-03883","effective_on":null,"end_page":10043,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/02/25/2015-03883.xml","html_url":"https://www.federalregister.gov/documents/2015/02/25/2015-03883/over-the-counter-sunscreen-drug-products-regulatory-status-of-ecamsule","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-03883?publication_date=2015-02-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-02-25/2015-03883/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":3215,"last_updated":"2026-10-23 16:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-02-25/pdf/2015-03883.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-03883.pdf?1424785768","publication_date":"2015-02-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/02/25/2015-03883.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 10 - International Conference on Harmonization (ICH) Guideline for Industry, Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies S3A, March 1995","document_id":"FDA-2008-N-0474-0028"},{"title":"Reference 9 - International Conference on Harmonization (ICH)  Harmonized Tripartite Guideline for Industry Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(R2), 2005","document_id":"FDA-2008-N-0474-0027"},{"title":"Reference 8 - International Conference on Harmonization (ICH) Guidance for Industry - S1C(R2) Dose Selection for Carcinogenicity Studies (Revision 1), September 2008","document_id":"FDA-2008-N-0474-0026"},{"title":"Reference 7 - International Conference on Harmonization (ICH) Guidance for Industry, S1B Testing for Carcinogenicity of Pharmaceuticals, July 1997","document_id":"FDA-2008-N-0474-0025"},{"title":"Reference 6 - International Conference on Harmonization (ICH), Guidance for Industry, The Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals S1A, March 1996","document_id":"FDA-2008-N-0474-0024"},{"title":"Reference 5 - FDA Guidance for Industry, Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application, February 1987","document_id":"FDA-2008-N-0474-0023"},{"title":"Reference 4 - Schmidt et al, Photoallergic Contact Dermatitis Due to Combined UVB (4-Methylbenzylidene Camphor/Octyl Methoxycinnamate) and UVA (Benzophenone-3/Butyl Methoxydibenzoylmethane) Absorber Sensitization","document_id":"FDA-2008-N-0474-0022"},{"title":"Reference 3 - Schauder et al, Contact and Photocontact Sensitivity to Sunscreens. Review of a 15-Year Experience and of the Literature","document_id":"FDA-2008-N-0474-0021"},{"title":"Reference 2 - Leonard et al, The New Standard Battery of Photopatch Test in France.","document_id":"FDA-2008-N-0474-0020"},{"title":"Reference 1 - FDA, Guidance for Industry, Photosafety Testing, May 2003","document_id":"FDA-2008-N-0474-0019"}],"comments_count":8,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2008-N-0474","supporting_documents_count":25,"docket_id":"FDA-2008-N-0474","document_id":"FDA-2008-N-0474-0018","regulation_id_number":null,"title":"Ecamsule Eligibility for Inclusion in Monograph; Over-the-Counter Sunscreen Drug Products for Human Use","checked_regulationsdotgov_at":"2023-03-01T05:10:41Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":10035,"subtype":null,"title":"Over-the-Counter Sunscreen Drug Products-Regulatory Status of Ecamsule","toc_doc":"Status of Ecamsule","toc_subject":"Over-the-Counter Sunscreen Drug Products:","topics":[],"type":"Proposed Rule","volume":80}