# STEARIC ACID (stearic-acid) — Global Cosmetic Regulatory & Formulation Monograph - **Canonical URL**: https://www.inciname.com/en/ingredients/stearic-acid - **Standard INCI**: `STEARIC ACID` - **KR MFDS Standard Name**: `스테아릭애씨드` - **CAS No.**: `57-11-4` - **EC / EINECS No.**: `200-313-4` - **Origin**: `synthetic` - **Functions**: 세정제, 향료, 유화제, 유화안정제, 재지방화제 - **Molecular Formula / MW**: `—` (— g/mol) ## 1. 7-Track Official Regulatory Label Names | Track | Official Label Nomenclature | | :--- | :--- | | KR (MFDS Standard) | 스테아릭애씨드 | | KR (Former Names) | — | | EU (CosIng 1223/2009) | STEARIC ACID | | US (PCPC / MoCRA INCI) | STEARIC ACID | | US (FDA OTC Monograph) | — | | CN (NMPA IECIC) | 硬脂酸 | | JP (JCIA / MHLW QD) | ステアリン酸 (QD: ステアリン酸) | ## 2. Layer 1 — Global 6-Region Statutory Summary - **KR (MFDS)**: `none` - **EU (1223/2009)**: `none` - **US (FDA/MoCRA)**: `none` - **CN (NMPA IECIC)**: `allowed` (Entry: `8028`) - **JP (MHLW)**: `none` - **ASEAN (ACD)**: `none` ## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations - **cn_iecic_max** (leave_on): ≤ 20% — NMPA IECIC (2025) Entry 07918 (2025) - **cn_iecic_max** (rinse_off): ≤ 15% — NMPA IECIC (2025) Entry 07918 (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: STEARIC ACID | CAS No.: 57-11-4 | EC No.: 200-313-4 - Origin: SYNTHETIC | Functions: , , , , - Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS - Official Regional Label Names: US [STEARIC ACID] · EU [STEARIC ACID] · CN [硬脂酸] · JP [ステアリン酸] · JP Quasi-Drug [ステアリン酸] ■ [2. Dermatological Mechanism of Action & Functional Role] - STEARIC ACID 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. 8028 (硬脂酸)) - 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 20.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 15.0% ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [emulsion_cream] Typical range: 0.5 ~ 16.5% (Median 2.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=15, EVONIK 9 · GRANT 3 · SEPPIC 3)) — Emulsion cream & lotion structural / conditioning agent - [sun_color] Typical range: 0.6 ~ 11.0% (Median 2.95%, Ref: Global Starter Formulation Library Statistical Distribution (n=12, EVONIK 6 · GRANT 5 · 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: STEARIC ACID ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 42142203 (2026, Discov Nano): Development and preclinical evaluation of quiniodochlor-loaded nanostructured lipid carrier-chitosan gel for topical ant - PMID 41844721 (2026, Sci Rep): Bioactive-fat engineered nanostructured lipid carriers from Illipe butter: optimized design and enhanced in vitro anti-i - PMID 41556321 (2026, Pharm Dev Technol): Clobetasol propionate loaded nanostructured lipid carrier gel: formulation strategy and in vitro performance evaluation ## 6. Linked PubMed Literature - [PMID: 42142203] Development and preclinical evaluation of quiniodochlor-loaded nanostructured lipid carrier-chitosan gel for topical antifungal therapy — *Discov Nano* (2026) - [PMID: 41844721] Bioactive-fat engineered nanostructured lipid carriers from Illipe butter: optimized design and enhanced in vitro anti-inflammatory performance — *Sci Rep* (2026) - [PMID: 41556321] Clobetasol propionate loaded nanostructured lipid carrier gel: formulation strategy and in vitro performance evaluation — *Pharm Dev Technol* (2026) - [PMID: 41552988] Comparative in vivo assessment of hair-growth efficacy using nanostructured lipid carriers individually loaded with lavender oil or tea seed oil — *Pharm Dev Technol* (2026) - [PMID: 41355606] Broad-Spectrum Antibacterial Activity of Postbiotic From Lacticaseibacillus paracasei BGP1 Against Multidrug-Resistant Skin Wound Pathogens — *Microbiologyopen* (2025) - [PMID: 41303974] Guerbet Alcohols, Ideal Substrates for the Sustainable Production of Branched Esters — *Materials (Basel)* (2025) - [PMID: 41291000] Development and optimization of Moxifloxacin solid lipid nanoparticles via double emulsion organic solvent free technique applying Box-Behnken experimental design — *Sci Rep* (2025) - [PMID: 41149379] Development and Evaluation of Nystatin-Loaded Novasomal Gel for the Treatment of Candida albicans Infection: In Vitro Microbiological and Skin Compatibility Study — *Gels* (2025) - [PMID: 41033243] Structural color generation in lipid-based cosmetics: Lamellar nanosheets from skin-identical fatty acids — *Colloids Surf B Biointerfaces* (2026) - [PMID: 42218358] Dual-drug nanostructured lipid carriers of spironolactone and 2-deoxy-D-ribose for targeted follicular delivery in androgenetic alopecia — *Drug Deliv Transl Res* (2026) - [PMID: 41599160] Emulsome-Based Nanocarrier System for Controlled 4-Phenylbutyric Acid Delivery and Mechanistic Mitigation of Arsenical-Induced Skin Injury via Foam Application — *Pharmaceutics* (2025) - [PMID: 41334231] Fatty Acids Pattern, Essential Oil Content and Constituents of Some Sage Species (Salvia sp.) Native to Iran: Usable in Food Industry — *Food Sci Nutr* (2025)