UREA PEROXIDE
Commonly Found In
Overview
UREA PEROXIDE (carbamide peroxide) is a stable crystalline adduct of hydrogen peroxide and urea, used primarily as an oxidizing agent in tooth whitening products and hair bleaching formulations. It releases hydrogen peroxide gradually upon contact with moisture, providing controlled bleaching action. In cosmetic applications, it is primarily associated with dental use (tooth whitening), where it is regulated differently from skin-contact cosmetics. The EU bans it from cosmetics under Annex III/12 but permits it in oral hygiene products (dentist-applied: up to 6% hydrogen peroxide equivalent; for sale to the public: up to 0.1%). In the US and Japan, it is permitted in pharmaceutical and dental products. It is not typically used in skincare products and carries a higher irritancy profile than skin-contact cosmetic ingredients.
Also known as: Carbamide Peroxide, Urea Peroxide, Urea Hydrogen Peroxide, CO(NH2)2Β·H2O2
Key Benefits
Urea peroxide is not used as a skincare active ingredient. Its primary applications are tooth whitening and hair bleaching, where studies suggest it may provide effective oxidative bleaching through controlled hydrogen peroxide release. It does not provide skin-conditioning benefits.
Supporting Research
- β’ Li (1996) β clinical study on carbamide peroxide (urea peroxide) 10% for tooth whitening efficacy (Compend Contin Educ Dent)
Skin Compatibility Ratings
Comedogenic Rating
Non-comedogenic; oxidizing bleaching agent used in oral hygiene products.
Source: CIR Expert Panel; physicochemical properties
Irritancy Rating
Oxidizing agent with irritancy potential on soft tissue; causes transient gingival irritation in dental use. Skin contact may cause bleaching and irritation. Concentration-dependent.
Source: EU SCCS assessment; dental and dermatological literature
Typical Use Concentration
Range
10β35% in dental products
Optimal
10β16% (home use); 35% (professional dental)
EU Annex III/12: banned from cosmetics except oral hygiene products (β€0.1% H2O2 equivalent for consumer sale; up to 6% for dentist-supervised use). US: permitted in pharmaceutical dental products.
Commonly Found In
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 | Restricted | - | Follows EU regulations (III/12) | Official β |
π Why Regulations Differ
Urea peroxide is banned in EU cosmetics (Annex III/12) but permitted in oral hygiene products under concentration restrictions. The US and Japan permit it in pharmaceutical dental and ear care products. This significant divergence reflects its primary application domain (dental/pharmaceutical rather than skincare cosmetics) and the different risk-benefit frameworks applied to oxidizing agents in tooth whitening versus general cosmetics.
Regulation Analysis
Regional Agreement
Banned in EU but allowed in USA, Japan.
Category Comparison
There are 14 ingredients in the OXIDISING category. 100% are banned in at least one major market.
Strictness Ranking
πΏ Natural Sources
Synthetic compound, carbamide peroxide. Not found in nature. An adduct of hydrogen peroxide and urea.
π How It's Made
Synthesized by crystallization from a mixture of hydrogen peroxide and urea in aqueous solution. Chemical formula: CH6N2O3 or CO(NH2)2Β·H2O2.
π Uses in Cosmetics
Used as an oxidizing agent in tooth whitening products and hair bleaching formulations. Banned in EU (Annex III/12) and restricted in UK. Allowed in US and Japan. Releases hydrogen peroxide slowly, providing bleaching action. Typically used at 10-35% in dental whitening products.
π¬ Other Applications
Pharmaceutical applications: ear wax removal, antiseptic for minor wounds. Food industry: bleaching agent and oxidizer. Laboratory reagent.
π‘ Fun Facts
- β’ Also known as carbamide peroxide - the name 'carbamide' is an older term for urea
- β’ Releases about 35% of its weight as hydrogen peroxide, making it a safer, more stable alternative to pure H2O2 for consumer products
- β’ EU banned it in cosmetics but allows it in oral hygiene products under strict concentration limits
Related Skin Concerns
Data Sources
- β’ EU Cosmetics Regulation Annex III/12
- β’ EU SCCS opinion on hydrogen peroxide for tooth whitening
- β’ FDA 21 CFR dental product regulations
- β’ Japan MHLW pharmaceutical product regulations
Last data verification: 2026-04-16
Learn More
Frequently Asked Questions
Why is UREA PEROXIDE banned in the EU but allowed in the US?
The EU follows a precautionary principle, banning UREA PEROXIDE under III/12 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 UREA PEROXIDE banned in the EU but allowed in Japan?
The EU prohibits UREA PEROXIDE (III/12) 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 UREA PEROXIDE used for in cosmetics?
UREA PEROXIDE is primarily used for oxidising in cosmetic products. The ingredient is commonly found in various cosmetic and personal care products.
Which countries regulate UREA PEROXIDE?
UREA PEROXIDE is banned in EU. It has concentration limits or usage restrictions in UK. The ingredient is freely allowed in JP, US.
Are there alternatives to UREA PEROXIDE?
Due to regulatory restrictions on UREA PEROXIDE, cosmetic manufacturers often use alternative ingredients with similar functions. For oxidising, 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.