# CETYL ALCOHOL (cetyl-alcohol) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/cetyl-alcohol
- **Standard INCI**: `CETYL ALCOHOL`
- **KR MFDS Standard Name**: `세틸알코올`
- **CAS No.**: `36653-82-4`
- **EC / EINECS No.**: `253-149-0`
- **Origin**: `synthetic`
- **Functions**: 향료, 불투명화제, 에모리엔트, 유화제, 유화안정제, 거품증진제, 세정제, 점도조절제
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 세틸알코올 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | CETYL ALCOHOL |
| US (PCPC / MoCRA INCI) | CETYL ALCOHOL |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 鲸蜡醇 |
| JP (JCIA / MHLW QD) | セタノール (QD: セタノール) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `3526`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 15% — NMPA IECIC (2025) Entry 03495 (2025)
- **cn_iecic_max** (rinse_off): ≤ 10% — NMPA IECIC (2025) Entry 03495 (2025)

## 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: CETYL ALCOHOL | CAS No.: 36653-82-4 | EC No.: 253-149-0
  - Origin: SYNTHETIC | Functions: , , , , , , , 
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: non-ionic | CosIng/MFDS 
  - Official Regional Label Names: US [CETYL ALCOHOL] · EU [CETYL ALCOHOL] · CN [鲸蜡醇] · JP [セタノール] · JP Quasi-Drug [セタノール]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - CETYL ALCOHOL functions primarily as , , , , , , ,  in dermatological and cosmetic formulations. 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. 3526 (鲸蜡醇))
  - 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): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 15.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 10.0%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [aqueous_serum] Typical range: 0.2 ~ 2.0% (Median 1.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=7, GRANT 7)) — Aqueous serum, toner & hydrogel matrix formulation component
  - [emulsion_cream] Typical range: 0.5 ~ 1.2% (Median 0.6%, Ref: Global Starter Formulation Library Statistical Distribution (n=14, GRANT 13 · SEPPIC 1)) — Emulsion cream & lotion structural / conditioning agent
  - [sun_color] Typical range: 0.55 ~ 3.0% (Median 1.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=8, GRANT 6 · ELEMENTIS 1 · SEPPIC 1)) — Sun care & color cosmetics dispersion / sensory modifier
■ [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: CETYL ALCOHOL
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 40978887 (2025, Cureus): Clinical Evaluation of a Soap-Free Cleansing Lotion Containing Sodium Cocoyl Apple Amino Acids for Effective Impurity Re
  - PMID 40672672 (2025, ACS Pharmacol Transl Sci): Propolis-Loaded Niosomes for Dermopharmaceutic and Cosmetic Applications: Development, Stability, Safety, and In Vitro B
  - PMID 37836750 (2023, Molecules): Cannabidiol-Loaded Lipid-Stabilized Nanoparticles Alleviate Psoriasis Severity in Mice: A New Approach for Improved Topi

## 6. Linked PubMed Literature
- [PMID: 40978887] Clinical Evaluation of a Soap-Free Cleansing Lotion Containing Sodium Cocoyl Apple Amino Acids for Effective Impurity Removal and Skin Barrier Preservation in Healthy Adults With Diverse Skin Types — *Cureus* (2025)
- [PMID: 40672672] Propolis-Loaded Niosomes for Dermopharmaceutic and Cosmetic Applications: Development, Stability, Safety, and In Vitro Bioactivity Studies — *ACS Pharmacol Transl Sci* (2025)
- [PMID: 37836750] Cannabidiol-Loaded Lipid-Stabilized Nanoparticles Alleviate Psoriasis Severity in Mice: A New Approach for Improved Topical Drug Delivery — *Molecules* (2023)
- [PMID: 37164691] A Sucrose Fatty Acid Ester-mixed Emulsifier as Stabilizer of Emulsion Systems — *J Oleo Sci* (2023)
- [PMID: 37119885] Development and quality assessment of glutathione tripeptide loaded niosome containing carbopol emulgels as nanocosmeceutical formulations — *Int J Biol Macromol* (2023)
- [PMID: 36838759] The Fundamental Role of Lipids in Polymeric Nanoparticles: Dermal Delivery and Anti-Inflammatory Activity of Cannabidiol — *Molecules* (2023)
- [PMID: 36431860] Formulation of the Polysaccharide FucoPol into Novel Emulsified Creams with Improved Physicochemical Properties — *Molecules* (2022)
- [PMID: 35256558] Natural Is Not Always Better: The Prevalence of Allergenic Ingredients in "Clean" Beauty Products — *Dermatitis* (2022)
- [PMID: 35174533] Seven cases of contact dermatitis due to stearyl alcohol contained in topical medications — *J Dermatol* (2022)
- [PMID: 34714546] Investigating the influence of excipient batch variation on the structure, consistency and physical stability of polysorbate 60-based topical vehicles — *Int J Cosmet Sci* (2021)
- [PMID: 38460769] Development of solid lipid microparticles (SLMs) containing asiatic acid for topical treatment of acne: Characterization, stability, in vitro and in vivo anti-acne assessment — *Int J Pharm* (2024)
- [PMID: 37335816] Formulation, characterization of Quercus infectoria (Olivier) emulsions, and in vitro, in vivo evaluation as cosmeceutical formulation — *J Cosmet Dermatol* (2023)