# COCAMIDOPROPYL BETAINE (cocamidopropyl-betaine) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/cocamidopropyl-betaine
- **Standard INCI**: `COCAMIDOPROPYL BETAINE`
- **KR MFDS Standard Name**: `코카미도프로필베타인`
- **CAS No.**: `97862-59-4`
- **EC / EINECS No.**: `263-058-8`
- **Origin**: `synthetic`
- **Functions**: 대전방지제, 세정제, 모발컨디셔닝제, 거품증진제, 점도조절제, 피부컨디셔닝제
- **Molecular Formula / MW**: `C19H38N2O3` (342.52 g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 코카미도프로필베타인 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | COCAMIDOPROPYL BETAINE |
| US (PCPC / MoCRA INCI) | COCAMIDOPROPYL BETAINE |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 椰油酰胺丙基甜菜碱 |
| JP (JCIA / MHLW QD) | COCAMIDOPROPYL BETAINE  |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `7555`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **reported_use** (bath): 0.06~61% — 116_tent_capb.pdf (null)
- **reported_use** (eye): 0.005~3% — 116_tent_capb.pdf (null)
- **reported_use** (hair): 0.2~9% — 116_tent_capb.pdf (null)
- **reported_use** (hair_dye): 0.6~6% — 116_tent_capb.pdf (null)
- **cn_iecic_max** (leave_on): ≤ 2% — NMPA IECIC (2025) Entry 07605 (2025)
- **cn_iecic_max** (rinse_off): ≤ 30% — NMPA IECIC (2025) Entry 07605 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 4.5 – 8.5
- **Max Process Temp**: ≤ 80°C
- **Synergy Pairings**: SODIUM COCOYL ISETHIONATE, COCO-GLUCOSIDE, SODIUM CHLORIDE
- **Incompatibilities**: Select high-purity cosmetic grades with strictly controlled DMAPA and amidoamine trace impurities

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: COCAMIDOPROPYL BETAINE | CAS No.: 97862-59-4 | EC No.: 263-058-8
  - Origin: SYNTHETIC | Functions: , , , , , 
  - Physicochemical Profile: Formula C19H38N2O3 | MW 342.52 g/mol | /   | Ionic Nature: amphoteric | PubChem CID 20280
  - Official Regional Label Names: US [COCAMIDOPROPYL BETAINE] · EU [COCAMIDOPROPYL BETAINE] · CN [椰油酰胺丙基甜菜碱] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Cocamidopropyl Betaine is the zwitterion (inner salt) that conforms generally to the formula: Classified under origin 'synthetic', it acts within the cosmetic vehicle or stratum corneum to deliver , , , , ,  performance and structural formulation stability.
■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)]
  - Regional Summary: KR: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 7555 (椰油酰胺丙基甜菜碱))
  - No specific Annex prohibition or numeric restriction across the 6 major jurisdictions (Permitted under general GMP safety assessment).
  - Official Safety & Historical Use Concentration (Layer 2): cir (reported_use, bath): 0.06~61% / cir (reported_use, eye): 0.005~3% / cir (reported_use, hair): 0.2~9%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [cleanser_rinse] Typical range: 2.0 ~ 25.0% (Median 7.0%, Ref: Evonik TEGO Betain F 50 TDS & CIR Assessment) — Amphoteric co-surfactant for irritation reduction, foam boosting & salt-thickening
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Water / Surfactant Phase
  - Optimal pH Range: pH 4.5 ~ 8.5 | Max Process Temp: Max 80°C | Electrolyte Tolerance: HIGH
  - Incompatibility / Caution: Select high-purity cosmetic grades with strictly controlled DMAPA and amidoamine trace impurities
  - Synergy Pairings: SODIUM COCOYL ISETHIONATE, COCO-GLUCOSIDE, SODIUM CHLORIDE | Reference Trade Names: TEGO® Betain F 50, Dehyton® PK 45
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 41488827 (2026, Case Rep Dermatol Med): Two Cases of Allergic Contact Dermatitis Caused by Coco Betaine in Clobetasol Propionate Shampoo
  - PMID 41485899 (2026, J Oleo Sci): Infrared Spectroscopic Analysis Indicates That Cocamidopropyl Betaine Has Little Effect on the Stratum Corneum
  - PMID 41429426 (2026, Contact Dermatitis): Strengths and Limitations of Sodium Lauryl Sulfate as an Irritant Control in Patch Testing

## 6. Linked PubMed Literature
- [PMID: 41488827] Two Cases of Allergic Contact Dermatitis Caused by Coco Betaine in Clobetasol Propionate Shampoo — *Case Rep Dermatol Med* (2026)
- [PMID: 41485899] Infrared Spectroscopic Analysis Indicates That Cocamidopropyl Betaine Has Little Effect on the Stratum Corneum — *J Oleo Sci* (2026)
- [PMID: 41429426] Strengths and Limitations of Sodium Lauryl Sulfate as an Irritant Control in Patch Testing — *Contact Dermatitis* (2026)
- [PMID: 41417527] Children's soap pH analysis and its meaning in children's skin cleansing — *Rev Paul Pediatr* (2025)
- [PMID: 40422340] Application of a Dopa Derivative for the Formation of Gels in the Presence of Commercial Surfactants — *Gels* (2025)
- [PMID: 39501833] Allergic Contact Dermatitis Associated With Men's Personal Care Products: A Review of Allergens — *Dermatitis* (2025)
- [PMID: 40133141] Cocamidopropyl betaine: another possible oral healthcare chemical associated with plasma cell lesions of the oral cavity — *Oral Surg Oral Med Oral Pathol Oral Radiol* (2025)
- [PMID: 41685624] Preservative Kinetics and Influence of Surfactants on Gram-Negative Bacterial Membrane Partitioning — *Langmuir* (2026)
- [PMID: 41649178] Patterns of Sensitization and Cross-Reactivity in Hair Dye Allergy: An 18-Year Tertiary-Center Experience from Greece — *Dermatitis* (2026)
- [PMID: 41503492] Decyl glucoside as a sustainable surfactant for cosmetic formulations: environmental stability under hardness, pH, and temperature variations — *RSC Adv* (2026)
- [PMID: 41304500] From Safety Evaluation to Influencing Factors Analysis: A Comprehensive Investigation on Ocular Irritation of Baby Bath Products — *Toxics* (2025)
- [PMID: 39498636] Deposition of Nanometric Polymer-Surfactant Complexes Formed by Cationic Dextran: A Path to Sustainable Formulations — *Langmuir* (2024)