Nonanedioic Acid (AZELAIC ACID)
Commonly Found In
Overview
AZELAIC ACID is a cosmetic ingredient primarily used for SKIN CONDITIONING and ANTIMICROBIAL properties. It is a saturated dicarboxylic acid that treats acne, rosacea, and hyperpigmentation through multiple mechanisms.
Also known as: Nonanedioic Acid, 1,7-Heptanedicarboxylic Acid, Azepur99, Skinoren (brand)
Key Benefits
Clinical evidence indicates that azelaic acid may help reduce acne lesions by inhibiting the growth of Cutibacterium acnes (formerly P. acnes) and normalizing keratinocyte differentiation. Studies suggest it also inhibits tyrosinase, which may contribute to improvements in post-inflammatory hyperpigmentation and melasma over several weeks of use.
Supporting Research
- โข Graupe et al. (1996) โ 20% azelaic acid cream compared favorably to tretinoin 0.05% for acne (JAAD)
- โข Breathnach (1999) โ review of azelaic acid's dual mechanism in acne and pigmentation (J Dermatol Treat)
- โข Fitton & Goa (1991) โ comprehensive review of azelaic acid in acne and rosacea (Drugs)
Skin Compatibility Ratings
Comedogenic Rating
Non-comedogenic; may actually help normalize follicular hyperkeratinization
Source: CIR Expert Panel; clinical literature consensus
Irritancy Rating
Mild transient burning, stinging, or tingling may occur at treatment initiation, particularly at prescription strengths (15โ20%), typically diminishing with continued use
Source: CIR Expert Panel; FDA prescribing information for Finacea/Azelex
Typical Use Concentration
Range
3โ20%
Optimal
10% (cosmetic); 15โ20% (prescription)
Up to 10% used in cosmetic products for brightening and skin conditioning. 15% gel (Finacea) and 20% cream (Azelex/Skinoren) are FDA/EMA-approved prescription formulations for acne and rosacea.
Works Well With / Avoid
Works Well With
Use With Caution
Water-soluble and stable at pH 4โ6. Works synergistically with niacinamide for combined anti-acne and brightening effects. Combining with benzoyl peroxide or retinol may increase dryness and irritation, particularly during initiation.
Commonly Found In
Global Regulation Summary
Overview of current status across major international markets.
Detailed Regional Status
| Region | Status | Max Conc. | Conditions | Source |
|---|---|---|---|---|
| ๐ช๐บ EU | Unknown | - | - | Official โ |
| ๐บ๐ธ USA | Unknown | - | - | Official โ |
| ๐ฏ๐ต Japan | Unknown | - | - | Official โ |
| ๐ฐ๐ท Korea | Unknown | - | - | Official โ |
| ๐ฌ๐ง UK | Unknown | - | - | Official โ |
๐ Why Regulations Differ
Azelaic acid holds dual cosmetic and pharmaceutical status in different markets. In the EU and US, high-concentration formulations (15โ20%) are classified as prescription drugs, while lower concentrations function as cosmetic active ingredients. No specific concentration cap applies to cosmetic use under EU Regulation 1223/2009.
Regulation Analysis
Category Comparison
97% of SKIN CONDITIONING ingredients (378 of 389) are banned in the EU, but this one is approved.
๐ฟ Natural Sources
Found in wheat, rye, and barley grains. Produced naturally by Malassezia furfur (Pityrosporum ovale), a yeast that lives on normal skin. First detected in rancid fats. Can be extracted from date palm vegetable oil.
๐ญ How It's Made
Industrially produced by ozonolysis of oleic acid; side product is nonanoic acid. Extraction involves oxidation synthesis of oleic acid from date palm vegetable oil followed by purification. Commercially available as cosmetic grade Azepur99ยฎ (99% minimum purity). Vegetable-based production uses sustainable sources.
๐ Uses in Cosmetics
Used at 3-20% depending on the product type. At 10% in cosmetics for brightening and smoothing skin; at 15-20% in prescription products for acne and rosacea. Often combined with niacinamide or other gentle acids for better results.
๐ฌ Other Applications
Used in food preservation, medical treatments for acne (20% cream) and rosacea (15% gel), both FDA-approved. Has been used clinically for nearly 40 years.
๐ก Fun Facts
- โข Discovered for skin use in the 1970s when a dermatologist in Rome noticed that a common skin condition caused lightening of the skin
- โข Some patients using it for dark spots accidentally discovered it also cleared up their acne, leading to its use for both purposes
- โข Naturally produced by yeast that lives on everyone's skin โ your body is already familiar with this ingredient
Related Skin Concerns
Data Sources
- โข FDA Prescribing Information โ Finacea Gel 15% and Azelex Cream 20%
- โข CIR Expert Panel Final Report on azelaic acid
- โข EU CosIng database
- โข Fitton & Goa, Drugs 1991;41(5):780-798
- โข Graupe et al., JAAD 1996;34:458-463
Last data verification: 2026-04-12
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CANNABIS SATIVA EXTRACT
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Learn More
Frequently Asked Questions
What is AZELAIC ACID used for in cosmetics?
AZELAIC ACID is primarily used for skin conditioning in cosmetic products. It also serves as antimicrobial, antioxidant. The ingredient is commonly found in moisturizers, lotions, and creams.
Which countries regulate AZELAIC ACID?
AZELAIC ACID is approved for cosmetic use in all major markets: , with no significant restrictions.
Where can I find official regulation information about AZELAIC ACID?
Official information about AZELAIC ACID regulations can be found on government websites: EU CosIng database, US FDA Cosmetics page, Japan MHLW cosmetics standards, UK Government cosmetics guidance, and Korea MFDS. Always verify regulatory status with these official sources before making formulation decisions.
Disclaimer
The information on this website is for educational and informational purposes only and is not intended as medical advice. While we strive for accuracy based on official government databases, cosmetic regulations change frequently. Always consult with a qualified professional or refer to the latest official regulatory documents for compliance. We are not responsible for any actions taken based on the information provided here.