# UREA (urea) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/urea
- **Standard INCI**: `UREA`
- **KR MFDS Standard Name**: `우레아`
- **CAS No.**: `57-13-6`
- **EC / EINECS No.**: `200-315-5`
- **Origin**: `synthetic`
- **Functions**: 대전방지제, pH조절제, 보습제, 피부컨디셔닝제, 완충제
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 우레아 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | UREA |
| US (PCPC / MoCRA INCI) | UREA |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 尿素 |
| JP (JCIA / MHLW QD) | UREA  |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `restricted`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `noted` (Entry: `4827`)
- **JP (MHLW)**: `noted`
- **ASEAN (ACD)**: `none`

- **KR** [limited]: ≤ 10% —  (화장품 안전기준 등에 관한 규정 [별표2] 사용상의 제한이 필요한 원료)
- **CN** [noted]: — —  (化妆品安全技术规范(2015년판) — 전수 검색)
- **JP** [noted]: — —  (화장품기준(厚生省告示第331号) 별표1 배합금지 30종 — 전수 대조)

## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- Listed within general cosmetic GMP safety thresholds.

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 4 – 8
- **Max Process Temp**: ≤ 50°C
- **Synergy Pairings**: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL
- **Incompatibilities**: Verify phase compatibility under extreme pH or high electrolyte loads

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: UREA | CAS No.: 57-13-6 | EC No.: 200-315-5
  - Origin: SYNTHETIC | Functions: , pH, , , 
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: non-ionic | CosIng/MFDS 
  - Official Regional Label Names: US [UREA] · EU [UREA] · CN [尿素] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - UREA functions primarily as , pH, , ,  in dermatological and cosmetic formulations. Classified under origin 'synthetic', it acts within the cosmetic vehicle or stratum corneum to deliver , pH, , ,  performance and structural formulation stability.
■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)]
  - Regional Summary: KR: RESTRICTED | EU: NONE | US: NONE | CN: NOTED | JP: NOTED | ASEAN: NONE (CN IECIC (2025) Entry No. 4827 (尿素))
  - [KR / COMPOSITION / limited] (Max 10%): 
  - [JP / COMPOSITION / noted]: 
  - [CN / COMPOSITION / noted]: 
  - Official Safety & Historical Use Concentration (Layer 2): Quantum satis (QS) within standard cosmetic safety margins
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [emulsion_cream] Typical range: 0.1 ~ 10.0% (Median 2.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=8, EVONIK 6 · GRANT 2)) — Emulsion cream & lotion structural / conditioning agent
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Water Phase or Cool-down Phase (< 45°C)
  - Optimal pH Range: pH 4.0 ~ 8.0 | Max Process Temp: Max 50°C | Electrolyte Tolerance: MEDIUM
  - Incompatibility / Caution: Verify phase compatibility under extreme pH or high electrolyte loads
  - Synergy Pairings: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL | Reference Trade Names: UREA
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 42202589 (2026, Bioorg Chem): Antineoplastic multi-targeted spiroindoline-3,2'-pyrrolidines incorporating urea function: Rational design, synthesis an
  - PMID 42316302 (2026, Clin Chem Lab Med): Novel Specturi urine collector device demonstrating high measurement accuracy and proven clinical usability
  - PMID 42296001 (2026, ACS Appl Mater Interfaces): Ti(3)C(2)T(x) MXene Nanosheets: Bridging High-Performance Energy Storage and Comprehensive In Vivo Biocompatibility Asse

## 6. Linked PubMed Literature
- [PMID: 42202589] Antineoplastic multi-targeted spiroindoline-3,2'-pyrrolidines incorporating urea function: Rational design, synthesis and bio-properties studies — *Bioorg Chem* (2026)
- [PMID: 42316302] Novel Specturi urine collector device demonstrating high measurement accuracy and proven clinical usability — *Clin Chem Lab Med* (2026)
- [PMID: 42296001] Ti(3)C(2)T(x) MXene Nanosheets: Bridging High-Performance Energy Storage and Comprehensive In Vivo Biocompatibility Assessment — *ACS Appl Mater Interfaces* (2026)
- [PMID: 42269409] Multifunctional polyacrylamide-gelatin deep eutectic gel with integrated antibacterial, antifreezing, and conductive properties for wearable motion sensing — *Talanta* (2026)
- [PMID: 42254381] Efficacy and safety of MuShengshu in the treatment of mild-to-moderate atopic dermatitis: protocol for a randomized, double-blind, placebo-controlled trial — *Front Med (Lausanne)* (2026)
- [PMID: 42244234] Pathogenesis of Male Genital Lichen Sclerosus: Autoimmunity versus the Urine/Occlusion Hypothesis - A Narrative Review — *Clin Exp Dermatol* (2026)
- [PMID: 42241669] Systemic Vascular and Organ Functions in Transgender Women Receiving Feminizing Hormone Therapy — *J Appl Physiol (1985)* (2026)
- [PMID: 42236212] Expression of aquaporin 3 in squamous cell carcinoma in dogs and cats — *J Vet Med Sci* (2026)
- [PMID: 42225610] Skin health in oncology: evidence-based skin care for cancer patients — *Oncologist* (2026)
- [PMID: 42219233] Oclacitinib for Controlling Pruritus and Associated Skin Lesions in 16 Horses With Allergic Dermatitis — *Vet Dermatol* (2026)
- [PMID: 42207072] IS THERE A RELATIONSHIP BETWEEN INTESTINAL FRUCTOSE MALABSORPTION, GASTROINTESTINAL SYMPTOMS AFTER FRUCTOSE OVERLOAD, AND BODY ADIPOSITY IN ADOLESCENTS? — *Arq Gastroenterol* (2026)
- [PMID: 42179648] Fatal pediatric paraquat poisoning following scalp application for head lice treatment: Public health implications for pesticide regulation and emergency care - A case series — *Toxicol Rep* (2026)