# STEARYL ALCOHOL (stearyl-alcohol) — Global Cosmetic Regulatory & Formulation Monograph - **Canonical URL**: https://www.inciname.com/en/ingredients/stearyl-alcohol - **Standard INCI**: `STEARYL ALCOHOL` - **KR MFDS Standard Name**: `스테아릴알코올` - **CAS No.**: `112-92-5` - **EC / EINECS No.**: `204-017-6` - **Origin**: `synthetic` - **Functions**: 향료, 불투명화제, 에모리엔트, 유화제, 유화안정제, 거품증진제, 재지방화제, 세정제, 점도조절제 - **Molecular Formula / MW**: `—` (— g/mol) ## 1. 7-Track Official Regulatory Label Names | Track | Official Label Nomenclature | | :--- | :--- | | KR (MFDS Standard) | 스테아릴알코올 | | KR (Former Names) | — | | EU (CosIng 1223/2009) | STEARYL ALCOHOL | | US (PCPC / MoCRA INCI) | STEARYL ALCOHOL | | US (FDA OTC Monograph) | — | | CN (NMPA IECIC) | 硬脂醇 | | JP (JCIA / MHLW QD) | ステアリルアルコール (QD: 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: `7972`) - **JP (MHLW)**: `none` - **ASEAN (ACD)**: `none` ## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations - **cn_iecic_max** (leave_on): ≤ 15% — NMPA IECIC (2025) Entry 07921 (2025) - **cn_iecic_max** (rinse_off): ≤ 10% — NMPA IECIC (2025) Entry 07921 (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: STEARYL ALCOHOL | CAS No.: 112-92-5 | EC No.: 204-017-6 - Origin: SYNTHETIC | Functions: , , , , , , , , - Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS - Official Regional Label Names: US [STEARYL ALCOHOL] · EU [STEARYL ALCOHOL] · CN [硬脂醇] · JP [ステアリルアルコール] · JP Quasi-Drug [ステアリルアルコール] ■ [2. Dermatological Mechanism of Action & Functional Role] - STEARYL 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. 7972 (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 10.0% ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [cleanser_rinse] Typical range: 0.5 ~ 15.6% (Median 1.25%, Ref: Global Starter Formulation Library Statistical Distribution (n=6, GRANT 6)) — Rinse-off cleanser & surfactant system modifier - [emulsion_cream] Typical range: 0.5 ~ 5.0% (Median 1.5%, Ref: Global Starter Formulation Library Statistical Distribution (n=50, EVONIK 40 · GRANT 10)) — Emulsion cream & lotion structural / conditioning agent - [sun_color] Typical range: 0.3 ~ 2.0% (Median 1.5%, Ref: Global Starter Formulation Library Statistical Distribution (n=6, GRANT 4 · EVONIK 2)) — 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: STEARYL ALCOHOL ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 42242705 (2026, Contact Dermatitis): Dupilumab Facial Redness Due to Allergic Contact Dermatitis and Malassezia Hypersensitivity: A Case Report - PMID 41400362 (2026, Drug Dev Ind Pharm): An in vitro release test method with Immersion Cells for evaluation of drug release performance of butenafine hydrochlor - PMID 40739062 (2025, AAPS PharmSciTech): Rational QbD-based Assessment of Formulation Ingredients' Impact on Sustainable Sunscreen Physical Stability ## 6. Linked PubMed Literature - [PMID: 42242705] Dupilumab Facial Redness Due to Allergic Contact Dermatitis and Malassezia Hypersensitivity: A Case Report — *Contact Dermatitis* (2026) - [PMID: 41400362] An in vitro release test method with Immersion Cells for evaluation of drug release performance of butenafine hydrochloride cream — *Drug Dev Ind Pharm* (2026) - [PMID: 40739062] Rational QbD-based Assessment of Formulation Ingredients' Impact on Sustainable Sunscreen Physical Stability — *AAPS PharmSciTech* (2025) - [PMID: 38379124] Effect of stearyl alcohol on imiquimod-induced psoriasis-like skin inflammation in mice — *Basic Clin Pharmacol Toxicol* (2024) - [PMID: 36855538] Development and Optimization of Imiquimod-Loaded Nanostructured Lipid Carriers Using a Hybrid Design of Experiments Approach — *Int J Nanomedicine* (2023) - [PMID: 36705648] Potential Allergens in Wound Care Products — *Dermatitis* (2023) - [PMID: 35174533] Seven cases of contact dermatitis due to stearyl alcohol contained in topical medications — *J Dermatol* (2022) - [PMID: 34214318] Development, characterization, molecular docking, and in vivo skin penetration of coenzyme Q10 nanostructured lipid carriers using tristearin and stearyl alcohol for dermal delivery — *J Basic Clin Physiol Pharmacol* (2021) - [PMID: 32835910] In vivo characterization of the structures of films of a fatty acid and an alcohol adsorbed on the skin surface — *Biophys Chem* (2020) - [PMID: 32063795] Allergic contact dermatitis of adjacent normal skin from 5-fluorouracil for the treatment of flat facial warts — *Proc (Bayl Univ Med Cent)* (2020) - [PMID: 31711663] Effect of the ratio between behenyl alcohol and behenic acid on the oleogel properties — *J Colloid Interface Sci* (2020) - [PMID: 38435100] Preparation of Transdermal Gel Containing l-Theanine for the Potential Treatment of Premenstrual Syndrome: A Preclinical Study — *Womens Health Rep (New Rochelle)* (2024)