FDA-Approved OTC Acne-Fighting Agent

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

FDA-Approved OTC Acne-Fighting Agent

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FDA-Approved OTC Acne-Fighting Agent 3

Product Overview

ZLEY® RA (INCI: Resorcinol Acetate), also known as Acetylresorcinol or 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

ParameterSpecification
INCI NameResorcinol Acetate
CAS Number102-29-4
AppearanceColorless to pale yellow viscous liquid, characteristic odor
Recommended Usage0.1 – 1.0% [Note: Up to 3% in the U.S. and Canada under OTC drug rules]
SolubilityInsoluble in water; soluble in alcohol and oils
Suitable FormulationsAnti-acne products, anti-dandruff products
ProcessingEmulsion systems: Add at low temperature after emulsification and mix thoroughly.
Anhydrous oil systems: Add directly to the oil phase and dissolve.
Thickener CompatibilitySuitable for ion-tolerant systems.
Storage NotesAvoid prolonged heating; store in light-protected conditions.

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 .

Product Applications

In cosmetics and skincare, ZLEY® RA functions primarily as a skin conditioning agent. 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®?

With over 20 years of dedicated experience, ZLEY® has evolved into a modern enterprise integrating research, production, quality control, and sales. We are committed to providing the highest quality personal care raw materials, semi-finished products, and customized formulation solutions to meet diverse customer needs. Our global delivery network ensures reliable service to customers in over 60 countries.

Email: [email protected]

What Technical Support Can You Expect?

As a specialized supplier, ZLEY® offers value beyond the product itself:

  • Formulation Support: Basic formulation recommendations, combination suggestions, and processing guidance
  • Regulatory Consulting: Assistance with interpreting compliance requirements for target markets (U.S. OTC Monograph, EU regulations, etc.)
  • Quality Assurance: Consistent quality, competitive pricing, and reliable global logistics
  • Market Intelligence: Latest market trends and ingredient application insights

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.