# CETEARYL ALCOHOL (cetearyl-alcohol) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/cetearyl-alcohol
- **Standard INCI**: `CETEARYL ALCOHOL`
- **KR MFDS Standard Name**: `세테아릴알코올`
- **CAS No.**: `8005-44-5`
- **EC / EINECS No.**: `267-008-6`
- **Origin**: `synthetic`
- **Functions**: 불투명화제, 에모리엔트, 유화제, 유화안정제, 거품증진제, 세정제, 점도조절제
- **Molecular Formula / MW**: `C34H70O2` (498.9 g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 세테아릴알코올 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | CETEARYL ALCOHOL |
| US (PCPC / MoCRA INCI) | CETEARYL ALCOHOL |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 鲸蜡硬脂醇 |
| JP (JCIA / MHLW QD) | セテアリルアルコール (QD: セトステアリルアルコール) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `3580`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 15% — NMPA IECIC (2025) Entry 03505 (2025)
- **cn_iecic_max** (rinse_off): ≤ 12% — NMPA IECIC (2025) Entry 03505 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 2.5 – 10
- **Max Process Temp**: ≤ 85°C
- **Synergy Pairings**: CETEARYL GLUCOSIDE, GLYCERYL STEARATE, BEHENTRIMONIUM CHLORIDE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE
- **Incompatibilities**: Gradual cooling with moderate agitation recommended to allow stable α-crystalline gel network equilibration

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: CETEARYL ALCOHOL | CAS No.: 8005-44-5 | EC No.: 267-008-6
  - Origin: SYNTHETIC | Functions: , , , , , , 
  - Physicochemical Profile: Formula C34H70O2 | MW 498.9 g/mol | LogP 7.5 | Ionic Nature: non-ionic | PubChem CID 62238
  - Official Regional Label Names: US [CETEARYL ALCOHOL] · EU [CETEARYL ALCOHOL] · CN [鲸蜡硬脂醇] · JP [セテアリルアルコール] · JP Quasi-Drug [セトステアリルアルコール]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Alcohols, C16-18 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. 3580 (鲸蜡硬脂醇))
  - 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 12.0%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [emulsion_cream] Typical range: 0.5 ~ 6.0% (Median 2.5%, Ref: Evonik TEGO Alkanol 1618 / Sasol NAFOL 1618 TDS & CIR) — Lamellar gel-network structuring fatty alcohol & viscosity builder
  - [cleanser_rinse] Typical range: 1.0 ~ 8.0% (Median 4.0%, Ref: CIR Cetearyl Alcohol Safety Assessment) — Hair conditioner lamellar structuring agent
  - [anhydrous_balm] Typical range: 0.5 ~ 22.0% (Median 3.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=19, EVONIK 11 · ELEMENTIS 3 · GRANT 3 · SEPPIC 2)) — Anhydrous balm, oil & stick structural emollient
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Oil Phase (Heat to 70~75°C)
  - Optimal pH Range: pH 2.5 ~ 10.0 | Max Process Temp: Max 85°C | Electrolyte Tolerance: HIGH
  - Incompatibility / Caution: Gradual cooling with moderate agitation recommended to allow stable α-crystalline gel network equilibration
  - Synergy Pairings: CETEARYL GLUCOSIDE, GLYCERYL STEARATE, BEHENTRIMONIUM CHLORIDE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE | Reference Trade Names: TEGO® Alkanol 1618 MB, NAFOL® 1618, Lanette® O
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 39714014 (2025, Australas J Dermatol): Allergens in ophthalmic medicaments in New Zealand
  - PMID 38069640 (2024, Clin Exp Dermatol): Do hypoallergenic skincare products contain fewer potential contact allergens?
  - PMID 37119885 (2023, Int J Biol Macromol): Development and quality assessment of glutathione tripeptide loaded niosome containing carbopol emulgels as nanocosmeceu

## 6. Linked PubMed Literature
- [PMID: 39714014] Allergens in ophthalmic medicaments in New Zealand — *Australas J Dermatol* (2025)
- [PMID: 38069640] Do hypoallergenic skincare products contain fewer potential contact allergens? — *Clin Exp Dermatol* (2024)
- [PMID: 37119885] Development and quality assessment of glutathione tripeptide loaded niosome containing carbopol emulgels as nanocosmeceutical formulations — *Int J Biol Macromol* (2023)
- [PMID: 32464232] Residual film formation after emulsion application: Understanding the role and fate of excipients on skin surface — *Int J Pharm* (2020)
- [PMID: 31231804] Allergic contact dermatitis caused dexpanthenol-But is that all? — *Contact Dermatitis* (2019)
- [PMID: 29785791] Cetearyl isononanoate, an underestimated contact allergen? — *Contact Dermatitis* (2018)
- [PMID: 29775655] Confocal Raman microspectroscopy as an alternative to differential scanning calorimetry to detect the impact of emulsifiers and formulations on stratum corneum lipid conformation — *Eur J Pharm Sci* (2018)
- [PMID: 29464717] Allergic contact dermatitis caused by sodium cetearyl sulfate — *Contact Dermatitis* (2018)
- [PMID: 28338538] Allergenic Ingredients in Facial Wet Wipes — *Dermatitis* (2017)
- [PMID: 28194803] The current spectrum of contact sensitization in patients with chronic leg ulcers or stasis dermatitis - new data from the Information Network of Departments of Dermatology (IVDK) — *Contact Dermatitis* (2017)
- [PMID: 42072063] Grape Pomace Extract-Loaded Liposomes Enriched Cream Formulations for Skincare — *Antioxidants (Basel)* (2026)
- [PMID: 41768678] Spontaneous Emulsification as a Low-Energy Strategy for Designing and Optimizing Resveratrol-Loaded Nanostructured Lipid Carriers — *ACS Omega* (2026)