# GLYCERYL STEARATE (glyceryl-stearate) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/glyceryl-stearate
- **Standard INCI**: `GLYCERYL STEARATE`
- **KR MFDS Standard Name**: `글리세릴스테아레이트`
- **CAS No.**: `31566-31-1`
- **EC / EINECS No.**: `250-705-4`
- **Origin**: `synthetic`
- **Functions**: 에모리엔트, 유화제
- **Molecular Formula / MW**: `C21H42O4` (358.56 g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 글리세릴스테아레이트 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | GLYCERYL STEARATE |
| US (PCPC / MoCRA INCI) | GLYCERYL STEARATE |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 甘油硬脂酸酯 |
| JP (JCIA / MHLW QD) | ステアリン酸グリセリル (QD: モノステアリン酸グリセリル) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `2490`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 15% — NMPA IECIC (2025) Entry 02375 (2025)
- **cn_iecic_max** (rinse_off): ≤ 10% — NMPA IECIC (2025) Entry 02375 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 4 – 9
- **Max Process Temp**: ≤ 85°C
- **Synergy Pairings**: PEG-100 STEARATE, CETEARYL ALCOHOL, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE
- **Incompatibilities**: Do not confuse pure non-ionic Glyceryl Stearate (HLB ~3.8) with Glyceryl Stearate SE (contains potassium/sodium stearate soap; breaks at pH < 6.8)

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: GLYCERYL STEARATE | CAS No.: 31566-31-1 | EC No.: 250-705-4
  - Origin: SYNTHETIC | Functions: , 
  - Physicochemical Profile: Formula C21H42O4 | MW 358.56 g/mol | LogP 6.9 | Ionic Nature: non-ionic | PubChem CID 24699
  - Official Regional Label Names: US [GLYCERYL STEARATE] · EU [GLYCERYL STEARATE] · CN [甘油硬脂酸酯] · JP [ステアリン酸グリセリル] · JP Quasi-Drug [モノステアリン酸グリセリル]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Stearic acid, monoester with glycerol 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. 2490 (甘油硬脂酸酯))
  - 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)]
  - [emulsion_cream] Typical range: 0.5 ~ 5.0% (Median 2.0%, Ref: Evonik TEGIN M / Arlacel 165 TDS & CIR Reported Use) — O/W co-emulsifier, consistency factor & lamellar body builder
  - [anhydrous_balm] Typical range: 0.5 ~ 5.0% (Median 3.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=11, EVONIK 7 · SEPPIC 2 · ELEMENTIS 1 · GRANT 1)) — Anhydrous balm, oil & stick structural emollient
  - [aqueous_serum] Typical range: 0.5 ~ 6.0% (Median 1.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=11, EVONIK 7 · ELEMENTIS 3 · GRANT 1)) — Aqueous serum, toner & hydrogel matrix formulation component
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Oil Phase (Heat to 75~80°C)
  - Optimal pH Range: pH 4.0 ~ 9.0 | Max Process Temp: Max 85°C | Electrolyte Tolerance: HIGH
  - Incompatibility / Caution: Do not confuse pure non-ionic Glyceryl Stearate (HLB ~3.8) with Glyceryl Stearate SE (contains potassium/sodium stearate soap; breaks at pH < 6.8)
  - Synergy Pairings: PEG-100 STEARATE, CETEARYL ALCOHOL, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE | Reference Trade Names: Arlacel™ 165 (with PEG-100 Stearate), SIMULSOL™ 165, TEGIN® M, Cutina® GMS V
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 41235541 (2026, Int J Cosmet Sci): Minimalist, bioinspired and sensorial emulsion based on a Ca(2+) double cone vector system using Design of Experiment (D
  - PMID 40739062 (2025, AAPS PharmSciTech): Rational QbD-based Assessment of Formulation Ingredients' Impact on Sustainable Sunscreen Physical Stability
  - PMID 40603073 (2025, J Oleo Sci): Preparation and Characterization of Emulsifier-free, Submicron-sized Monodisperse Rice Bran Wax Particles and their Appl

## 6. Linked PubMed Literature
- [PMID: 41235541] Minimalist, bioinspired and sensorial emulsion based on a Ca(2+) double cone vector system using Design of Experiment (DoE) — *Int J Cosmet Sci* (2026)
- [PMID: 40739062] Rational QbD-based Assessment of Formulation Ingredients' Impact on Sustainable Sunscreen Physical Stability — *AAPS PharmSciTech* (2025)
- [PMID: 40603073] Preparation and Characterization of Emulsifier-free, Submicron-sized Monodisperse Rice Bran Wax Particles and their Applicability — *J Oleo Sci* (2025)
- [PMID: 39586762] Falsely elevated triglyceride and lipase levels due to hyperglycerolemia in a burn patient treated with topical silver sulfadiazine — *J Clin Lipidol* (2025)
- [PMID: 37751399] Glyceryl Diesters — *Int J Toxicol* (2023)
- [PMID: 35610393] Development of Artificial-Sebum-Containing Leeming and Notman Agar Medium to Enhance the Growth of Malassezia — *Mycopathologia* (2022)
- [PMID: 31900792] Application of Factorial Design and Rheology to the Development of Photoprotective Formulations — *AAPS PharmSciTech* (2020)
- [PMID: 28559707] Formulation and evaluation of a water-in-oil cream containing herbal active ingredients and ferulic acid — *Clujul Med* (2017)
- [PMID: 28338538] Allergenic Ingredients in Facial Wet Wipes — *Dermatitis* (2017)
- [PMID: 39619544] Ultra-micro Liquid Crystal in Cosmetic Emulsion with Excellent Moisture Retention and Delivery Selectivity — *ACS Omega* (2024)
- [PMID: 39599220] Double Hydrophilic Hyperbranched Copolymer-Based Lipomer Nanoparticles: Copolymer Synthesis and Co-Assembly Studies — *Polymers (Basel)* (2024)
- [PMID: 38272417] Preparation and characterization of glyceryl stearate/cassava starch composite for wax therapy — *Int J Biol Macromol* (2024)