FDA承認の市販ニキビ治療薬

ZLEY® RA – Resorcinol Acetate (CAS 102-29-4):

FDA承認の市販ニキビ治療薬

製品概要

ZLEY® RA (INCI: Resorcinol Acetate), also known as Acetylresorcinol または Euresol, is a resorcinol derivative. It is recognized by the U.S. FDA as an approved active ingredient in over-the-counter (OTC) topical acne drug products and is listed in the U.S. OTC Drug Monograph for acne treatment. It offers antibacterial, post-acne spot-fading, and keratolytic properties. It is used to treat acne, seborrheic dermatitis, and tinea pedis, and is also effective as a mild, non-irritating anti-dandruff agent for the scalp.

ZLEY® is a professional supplier of Resorcinol Acetate (CAS 102-29-4), providing stable quality, technical support, and global delivery covering over 60 countries.

ZLEY® RA Product Information

Is ZLEY® RA Safe?

Yes. According to the U.S. FDA OTC Drug Monograph, Resorcinol Monoacetate (3%) is recognized as safe and effective (GRASE) for use in over-the-counter topical acne drug products when formulated according to established conditions . Safety assessments based on China’s “Information on the Use of Ingredients in Marketed Products” confirm that up to 1% in leave-on products is safe .

製品用途

In cosmetics and skincare, ZLEY® RA functions primarily as a 皮膚コンディショニング剤. Its key applications include

• Anti-acne products – Reduces blemishes, pimples, and blackheads 
• Anti-dandruff products – Mild, non-irritating scalp treatment
• Seborrheic dermatitis treatments
• Tinea pedis (athlete’s foot) treatments

Why Source ZLEY® RA from ZLEY®?

20年以上にわたる献身的な実績を積み重ねてきたZLEY®は、研究、生産、品質管理、販売を一体化した現代的な企業へと発展を遂げました。当社は、お客様の多様なニーズに応えるため、最高品質のパーソナルケア用原料、半製品、およびカスタマイズされた処方ソリューションの提供に尽力しています。当社のグローバルな配送ネットワークにより、60カ国以上のお客様に信頼性の高いサービスを提供しています。.

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どのようなテクニカルサポートが受けられますか？

専門サプライヤーとして、ZLEY®は製品そのものを超えた価値を提供しています：

• 処方サポート: 基本的な配合の推奨事項、配合の提案、および加工に関する指針
• 規制コンサルティング: Assistance with interpreting compliance requirements for target markets (U.S. OTC Monograph, EU regulations, etc.)
• 品質保証： 一貫した品質、競争力のある価格、そして信頼性の高いグローバル物流
• 市場情報： 最新の市場動向と原料の活用に関する知見

ZLEY® RA – Frequently Asked Questions (FAQ)

Q1: What is the FDA status of Resorcinol Acetate?

A: Resorcinol Acetate is listed as a Category I (GRASE – Generally Recognized as Safe and Effective) active ingredient for OTC topical acne drug products in the U.S. FDA regulations (21 CFR § 333.310). The monograph permits up to 3% Resorcinol Monoacetate (chemically equivalent to Resorcinol Acetate) in OTC acne products. It is also included in China’s “Inventory of Existing Cosmetic Ingredients (2021 Edition)”.

Q2: How does Resorcinol Acetate differ from Resorcinol?

A: Resorcinol Acetate is the esterified (acetylated) form of resorcinol. This structural modification reduces reactivity and irritation potential while maintaining effective acne-fighting properties, making it more suitable for controlled formulation use. Resorcinol itself is regulated in the EU for hair dye applications and cannot be used in leave-on cosmetics.

Q3: What are the regulatory concentration limits for different markets?

A:The concentration limits vary by market:

• U.S. (OTC Drug): Up to 3% 
• Canada: Up to 3% (permitted in OTC acne products).
• China (Cosmetics): Maximum historical use in leave-on products is 1% based on marketed product data. 
• EU： Resorcinol Acetate is not specifically listed in Annex V; formulators should verify compliance on a product-by-product basis

Q4: Is ZLEY® RA suitable for sensitive skin?

A: Resorcinol Acetate is generally considered milder than free resorcinol due to its esterified structure. However, individual skin tolerance may vary. For sensitive skin formulations, we recommend starting at lower concentrations (0.1–0.5%) and conducting patch testing. As with all OTC drug ingredients in the U.S., appropriate warnings and directions must be included on product labeling.