{"id":9652,"date":"2026-07-29T15:41:14","date_gmt":"2026-07-29T07:41:14","guid":{"rendered":"https:\/\/www.zleygroup.com\/?p=9652"},"modified":"2026-09-22T15:41:02","modified_gmt":"2026-09-22T07:41:02","slug":"fda-approved-otc-acne-fighting-agent","status":"publish","type":"post","link":"https:\/\/www.zleygroup.com\/ja\/fda-approved-otc-acne-fighting-agent\/","title":{"rendered":"Resorcinol Monoacetate in U.S. OTC Acne Products: FDA M006 Requirements"},"content":{"rendered":"
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Resorcinol Monoacetate in U.S. OTC Acne Products: What FDA Monograph M006 Actually Says<\/h2>\n
\"ZLEY
<\/figcaption><\/figure>\n

ZLEY\u00ae RA is resorcinol acetate, also called resorcinol monoacetate<\/strong> or acetylresorcinol (CAS 102-29-4<\/strong>). The names refer to the same compound, as shown in \u30d1\u30d6\u30b1\u30e0<\/a>. It is different from 4-Butylresorcinol, which we discuss as a cosmetic brightening ingredient<\/a>.<\/p>\n

The U.S. OTC acne monograph requirement<\/h3>\n

FDA’s OTC Monograph M006<\/a> lists resorcinol monoacetate at 3%<\/strong> as an active ingredient for topical acne drug products only when combined with sulfur at 3\u20138%<\/strong>. The same monograph separately lists resorcinol at 2% with sulfur at 3\u20138%. These are specified combinations, not a general permission to market resorcinol monoacetate alone as an OTC acne active or to claim that any product containing it is FDA approved.<\/p>\n\n\n\n\n\n
M006 combination<\/th>\nSpecified concentration<\/th>\n<\/tr>\n
Resorcinol monoacetate<\/td>\n3%<\/td>\n<\/tr>\n
Sulfur in that combination<\/td>\n3\u20138%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Meeting ingredient concentrations alone is not sufficient: a finished U.S. OTC acne drug must meet the applicable monograph’s other conditions, including labeling, as well as relevant general drug requirements. Verify the current requirements for the intended product before making treatment claims.<\/p>\n

Cosmetic ingredient or acne drug?<\/h3>\n

FDA distinguishes products by intended use and claims. A product marketed to treat acne<\/em> is regulated as a drug; a cosmetic claim does not automatically make a product eligible for an OTC acne indication. FDA explains this distinction in its cosmetic-versus-drug guidance<\/a>. The M006 entry also does not establish approval to treat dandruff, seborrheic dermatitis or athlete’s foot. Those are different indications with their own requirements.<\/p>\n

Requirements outside the United States need a separate, market-specific review. A historical use level, supplier recommendation or ingredient listing should not be presented as a universal legal maximum or a completed safety assessment.<\/p>\n

Questions for ingredient buyers<\/h3>\n

For grade-specific information, see the ZLEY\u00ae RA resorcinol acetate product page<\/a>. Request the current COA, TDS and SDS and confirm identity, assay, impurities, solubility and batch specifications. Tell the ZLEY\u00ae team your target market, finished-product format and intended claims so your regulatory and formulation teams can assess the appropriate pathway. Contact services@zleygroup.com<\/a> for documentation and sample availability.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

FDA OTC Monograph M006 lists resorcinol monoacetate at 3% only with sulfur at 3\u20138%. Learn the combination rule and buyer checks for ZLEY\u00ae RA.<\/p>","protected":false},"author":1,"featured_media":9653,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[69],"tags":[],"class_list":["post-9652","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-active-ingredients"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.zleygroup.com\/ja\/wp-json\/wp\/v2\/posts\/9652","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.zleygroup.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.zleygroup.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.zleygroup.com\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.zleygroup.com\/ja\/wp-json\/wp\/v2\/comments?post=9652"}],"version-history":[{"count":0,"href":"https:\/\/www.zleygroup.com\/ja\/wp-json\/wp\/v2\/posts\/9652\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.zleygroup.com\/ja\/wp-json\/wp\/v2\/media\/9653"}],"wp:attachment":[{"href":"https:\/\/www.zleygroup.com\/ja\/wp-json\/wp\/v2\/media?parent=9652"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.zleygroup.com\/ja\/wp-json\/wp\/v2\/categories?post=9652"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.zleygroup.com\/ja\/wp-json\/wp\/v2\/tags?post=9652"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}