CIS-RETINOIC ACID
Overview
CIS-RETINOIC ACID is a cosmetic ingredient primarily used for ANTI-SEBUM. It is commonly found in various cosmetic formulations and serves important functions in personal care products.
Also known as: Isotretinoin, 13-cis-Retinoic Acid, Accutane, Roaccutane
Key Benefits
Cis-retinoic acid (isotretinoin) is a potent retinoid that studies demonstrate may help normalize skin cell turnover and reduce sebum production. However, it is prohibited in cosmetics in the EU and UK, and classified as a prescription-only pharmaceutical in the US and Japan due to its potent activity and teratogenicity risk.
Skin Compatibility Ratings
Comedogenic Rating
Non-comedogenic; retinoid acid that normalizes follicular keratinization and reduces comedone formation.
Source: Kligman 1986; multiple clinical trials on tretinoin (all-trans-retinoic acid)
Irritancy Rating
Moderate-to-high irritancy; retinoic acid (both cis and trans isomers) causes retinoid dermatitis β erythema, peeling, dryness, and photosensitivity β especially during initial weeks. Categorized as a prescription drug in most countries, not a cosmetic ingredient.
Source: Kligman 1986; Leyden & Grove 2002 (Dermatology); FDA prescription drug classification
Typical Use Concentration
Range
N/A (prohibited in cosmetics)
Optimal
N/A
As a pharmaceutical, oral doses are 0.5β2 mg/kg/day. No cosmetic use is permitted.
Global Regulation Summary
Overview of current status across major international markets.
Detailed Regional Status
| Region | Status | Max Conc. | Conditions | Source |
|---|---|---|---|---|
| πͺπΊ EU | Banned | - | - | Official β |
| πΊπΈ USA | Allowed | - | - | Official β |
| π―π΅ Japan | Allowed | - | - | Official β |
| π°π· Korea | Unknown | - | - | Official β |
| π¬π§ UK | Banned | - | Follows EU regulations (II/375) | Official β |
π Why Regulations Differ
The EU prohibits cis-retinoic acid (isotretinoin) in all cosmetic products under Annex II/375 due to its severe teratogenic potential (causes birth defects) and the need for medical supervision. The US classifies it as Rx-only under the iPLEDGE program. Japan classifies it as a pharmaceutical.
Regulation Analysis
Regional Agreement
Banned in EU, UK but allowed in USA, Japan.
Category Comparison
There are 9 ingredients in the ANTI-SEBUM category. 100% are banned in at least one major market.
Strictness Ranking
πΏ Natural Sources
A naturally occurring metabolite of vitamin A in the human body. Present in small amounts in the blood and tissues. The body converts retinol (vitamin A) to various retinoic acid forms including this one.
π How It's Made
Produced synthetically by isomerization of all-trans retinoic acid, or by total chemical synthesis from beta-ionone. Pharmaceutical-grade production requires careful purification.
π Uses in Cosmetics
Used in cosmetic products primarily for anti-sebum.
π¬ Other Applications
Primarily used as a prescription medication (isotretinoin) for severe acne. Also used in cancer treatment (acute promyelocytic leukemia) and in dermatological research.
π‘ Fun Facts
- β’ 13-cis-retinoic acid is sold as Accutane/Isotretinoin β one of the most powerful and controversial acne medications ever created
- β’ It's so effective against severe acne that a single course of treatment (4-6 months) can permanently clear acne in about 85% of patients
- β’ It's one of the most strictly regulated medications in the world due to severe birth defect risks β in the US, both doctors and patients must register in a special program (iPLEDGE) to prescribe/receive it
Related Skin Concerns
Data Sources
- β’ EU CosIng database β Annex II/375
- β’ FDA iPLEDGE program documentation
- β’ PMDA (Japan) pharmaceutical classification
Last data verification: 2026-04-16
Related Ingredients
CANNABIDIOL - DERIVED FROM EXTRACT OR TINCTURE OR RESIN OF CANNABIS
CANNABIDIOL - SYNTHETICALLY PRODUCED
CANNABIS SATIVA EXTRACT
CANNABIS SATIVA FLOWER/LEAF/STEM EXTRACT
Learn More
Frequently Asked Questions
Why is CIS-RETINOIC ACID banned in the EU but allowed in the US?
The EU follows a precautionary principle, banning CIS-RETINOIC ACID under II/375 due to potential safety concerns. The US FDA has not found sufficient evidence to prohibit its use, allowing it under different safety assessment standards. This reflects differing regulatory philosophies between the two regions.
Why is CIS-RETINOIC ACID banned in the EU but allowed in Japan?
The EU prohibits CIS-RETINOIC ACID (II/375) based on their strict safety criteria. Japan's Ministry of Health, Labour and Welfare (MHLW) has evaluated the ingredient and permits its use, potentially with different safety data or usage conditions.
What is CIS-RETINOIC ACID used for in cosmetics?
CIS-RETINOIC ACID is primarily used for anti-sebum in cosmetic products. The ingredient is commonly found in various cosmetic and personal care products.
Which countries regulate CIS-RETINOIC ACID?
CIS-RETINOIC ACID is banned in EU, UK. The ingredient is freely allowed in JP, US.
Are there alternatives to CIS-RETINOIC ACID?
Due to regulatory restrictions on CIS-RETINOIC ACID, cosmetic manufacturers often use alternative ingredients with similar functions. For anti-sebum, alternatives may include other approved ingredients in the same category. Consult product labels for specific formulations, and look for products compliant with your region's regulations.
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.