{"id":324,"date":"2026-06-23T21:27:55","date_gmt":"2026-06-23T21:27:55","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-news\/?p=324"},"modified":"2026-06-23T21:27:55","modified_gmt":"2026-06-23T21:27:55","slug":"bemotrizinol-regulation","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-news\/2026\/06\/23\/bemotrizinol-regulation\/","title":{"rendered":"BEMOTRIZINOL REGULATION"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">US FDA\nregulates <a href=\"https:\/\/www.fdahelp.us\/fda_otc\/sunscreen.html\">sunscreens<\/a>\nas OTC drugs not as cosmetics. The manufacturers of sunscreen products must comply\nwith drug standards such as active ingredient requirements, specific SPF and broad-spectrum\ntesting methods and Drug facts labeling.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Apart from\nthat, sunscreen manufacturers must comply with all drug registration requirements,\nincluding cGMP (Current Good Manufacturing Practice), <a href=\"https:\/\/www.fdahelp.us\/fda-drug-registration.html\">Establishment\nregistration<\/a>,&nbsp;<a href=\"https:\/\/www.fdahelp.us\/fda-labeler-code.html\" target=\"_blank\" rel=\"noreferrer noopener\">FDA Labeler code&nbsp;<\/a>request, <a href=\"https:\/\/www.fdahelp.us\/fda-labeler-code.html\">Drug listing<\/a> and <a href=\"https:\/\/www.fdahelp.us\/fda-drug-label-review.html\">drug label compliance<\/a>\nand they are entitled to pay OMUFA fee as well.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Active Ingredients<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sunscreens use either mineral or\nchemical UV filters. The FDA permits a specific set of active ingredients, with\na notable update expanding the list: <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Bemotrizinol:<\/strong> It is first new active ingredient\nadded by FDA to <a href=\"https:\/\/www.fdahelp.us\/otc-drug-products.html\">OTC\nmonograph<\/a> under CARES Act after 2 decades since it is recognized as Generally\nRecognized as Safe and Effective (GRASE) for use in sunscreens by adults and\nchildren 6 months of age and older.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Zinc Oxide and Titanium Dioxide:<\/strong> These two mineral filters are\n     the only ones currently classified as Generally Recognized as Safe and\n     Effective (GRASE)<\/li><li><strong>Chemical Filters:<\/strong> Twelve other chemical filters\n     are currently undergoing review for GRASE status, requiring additional\n     safety data.<\/li><li><strong>Banned Ingredients:<\/strong> PABA and trolamine salicylate\n     are deemed not safe and effective. <\/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\">FDA approved dosage forms of sunscreen\nare oils, lotions, creams, gels, butters, pastes, ointments, sticks are classified\nas GRASE.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For newly approved OTC monograph active\ningredients like Bemotrizinol, FDA limits this to pump sprays or bag-on-valve\nsystems to prevent propellant contact and minimize inhalation risks.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Wipes or Towelettes, body washes or\ncleansers and shampoos are not considered as GRASE so these forms cannot be\nsold without approved NDA.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Labeling and Claims Requirements<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Water Resistance: Manufacturers cannot\nuse terms like &#8220;waterproof,&#8221; &#8220;sweatproof,&#8221; or\n&#8220;sunblock&#8221;. Instead, labels must explicitly state if the product\nremains effective for 40 or 80 minutes while swimming or sweating.<\/li><li>Broad-Spectrum Protection: Sunscreens\nwith SPF 15 or higher would be required to provide broad-spectrum protection,\nmeaning they must protect against both UVA and UVB radiation. <\/li><li>Protection Limits: Sunscreens cannot\nclaim to provide protection for longer than 2 hours without reapplication.<\/li><li>The FDA proposed clearer labeling\nrequirements for sunscreen products to help consumers identify key product\ninformation such as effectiveness claim, Water resistance statements, statement\nof identity, indications of use, warnings, and direction of use.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">All <a href=\"https:\/\/www.fdahelp.us\/otc-drug-products.html\">OTC drug products<\/a>,\nincluding sunscreens, must have an expiration date unless stability testing\nshows they remain 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-drug-label-review.html\">label review<\/a> and <a href=\"https:\/\/www.fdahelp.us\/fda-registration-agent.html\">US agent service<\/a> 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\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>US FDA regulates sunscreens as OTC drugs not as cosmetics. The manufacturers of sunscreen products must comply with drug standards such as active ingredient requirements, specific SPF and broad-spectrum testing methods and Drug facts labeling. Apart from that, sunscreen manufacturers must comply with all drug registration requirements, including cGMP (Current Good Manufacturing Practice), Establishment registration,&nbsp;FDA &hellip; <a href=\"https:\/\/www.libertymanagement.us\/fda-news\/2026\/06\/23\/bemotrizinol-regulation\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;BEMOTRIZINOL REGULATION&#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":[6,37,42],"class_list":["post-324","post","type-post","status-publish","format-standard","hentry","category-fda-registration-drug","tag-fda-drug-labeling","tag-fda-drug-listing-renewal","tag-fda-drug-registration"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/324","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=324"}],"version-history":[{"count":1,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/324\/revisions"}],"predecessor-version":[{"id":325,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/324\/revisions\/325"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/media?parent=324"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/categories?post=324"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/tags?post=324"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}