{"id":290,"date":"2025-05-27T18:19:51","date_gmt":"2025-05-27T18:19:51","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-news\/?p=290"},"modified":"2025-05-27T18:19:51","modified_gmt":"2025-05-27T18:19:51","slug":"sunscreen-regulations","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-news\/2025\/05\/27\/sunscreen-regulations\/","title":{"rendered":"SUNSCREEN REGULATIONS"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">As per US FDA regulations, <a href=\"https:\/\/www.fdahelp.us\/fda_otc\/sunscreen.html\">sunscreens<\/a> are\nconsidered as over the counter drugs. Sunscreen manufacturers must comply with\nall US FDA drug regulations such as <a href=\"https:\/\/www.fdahelp.us\/fda-drug-registration.html\">establishment\nregistration<\/a>, cGMP regulations, <a href=\"https:\/\/www.fdahelp.us\/fda-labeler-code.html\">drug listing<\/a> and label\ncompliance.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">As per drug regulations, the manufacturers must <a href=\"https:\/\/www.fdahelp.us\/drug-establishment-registration-renewal.html\">renew\ntheir registration<\/a> between October 1<sup>st<\/sup> and December 31<sup>st<\/sup>\nevery year and submit blanket listing submission as well.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Since Sunscreen products are considered as drug, the\nmanufacturer must pay <a href=\"https:\/\/www.fdahelp.us\/fda-otc-drug-fees-2025.html\">OMUFA<\/a> fee also.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Active Ingredients<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">US FDA has permitted 16 active ingredients used in\nsunscreens:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Zinc\n     oxide and titanium dioxide are considered as safe (GRASE &#8211; Generally\n     Recognized as Safe and Effective)<\/li><li>Because\n     of safety concerns PABA and trolamine salicylate are not considered safe.<\/li><li>For\n     twelve other ingredients, including oxybenzone and avobenzone, FDA has requested\n     additional safety data from manufacturers. <\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Dosage Forms<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The FDA proposed that certain sunscreen forms be\nconsidered GRASE:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Dosage\n     forms such asSprays, oils, lotions, creams, gels, butters, pastes,\n     ointments, and sticks are considered as GRASE.<\/li><li>Whereas\n     Wipes, towelettes, body washes, and shampoos are considered as Non GRASE,\n     which require FDA approval before marketing. <\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Sun Protection Factor (SPF) and\nBroad-Spectrum Requirements<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>SPF\n     Labeling:<\/strong> Proposed to raise the maximum labeled\n     SPF value from 50+ to 60+, while allowing formulations up to SPF 80 to\n     account for testing variability.<\/li><li><strong>Broad-Spectrum\n     Protection:<\/strong> Sunscreens with SPF 15 or higher would\n     be required to provide broad-spectrum protection, meaning they must\n     protect against both UVA and UVB radiation. <\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Labeling and Expiration Dates<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The FDA proposed clearer labeling requirements to help\nconsumers identify key product information. All OTC drug products, including\nsunscreens, must have an expiration date unless stability testing shows they\nremain stable for at least three years.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">Liberty Management Group<\/a> provides assistance with <a href=\"https:\/\/www.fdahelp.us\/fda-drug-registration.html\">drug establishment registration<\/a>, <a href=\"https:\/\/www.fdahelp.us\/fda-labeler-code.html\">drug listing<\/a> and <a href=\"https:\/\/www.fdahelp.us\/fda-label-review.html#1review\">label review<\/a> and US agent service to foreign drug companies.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sudha S<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Regulatory Consultant<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Email : office@libertymanagement.us<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">www.fdahelp.us<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>As per US FDA regulations, sunscreens are considered as over the counter drugs. Sunscreen manufacturers must comply with all US FDA drug regulations such as establishment registration, cGMP regulations, drug listing and label compliance. As per drug regulations, the manufacturers must renew their registration between October 1st and December 31st every year and submit blanket &hellip; <a href=\"https:\/\/www.libertymanagement.us\/fda-news\/2025\/05\/27\/sunscreen-regulations\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;SUNSCREEN REGULATIONS&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26],"tags":[40,33],"class_list":["post-290","post","type-post","status-publish","format-standard","hentry","category-fda-registration-drug","tag-fda-drug-registration-renewal","tag-fda-drug-reporting"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/290","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/comments?post=290"}],"version-history":[{"count":1,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/290\/revisions"}],"predecessor-version":[{"id":291,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/290\/revisions\/291"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/media?parent=290"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/categories?post=290"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/tags?post=290"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}