# PEG-100 STEARATE (peg-100-stearate) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/peg-100-stearate
- **Standard INCI**: `PEG-100 STEARATE`
- **KR MFDS Standard Name**: `피이지-100스테아레이트`
- **CAS No.**: `9004-99-3`
- **EC / EINECS No.**: `N/A`
- **Origin**: `synthetic`
- **Functions**: 세정제
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 피이지-100스테아레이트 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | PEG-100 STEARATE |
| US (PCPC / MoCRA INCI) | PEG-100 STEARATE |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | PEG-100 硬脂酸酯 |
| JP (JCIA / MHLW QD) | PEG-100 STEARATE  |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `494`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 10% — NMPA IECIC (2025) Entry 00548 (2025)
- **cn_iecic_max** (rinse_off): ≤ 6% — NMPA IECIC (2025) Entry 00548 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 4.5 – 7.5
- **Max Process Temp**: ≤ 70°C
- **Synergy Pairings**: —
- **Incompatibilities**: —

## 5. Academic Monograph
PEG-100 stearate was investigated as a component in emulsion formulations used together with sorbitan monostearate emulsifier.
Formulations containing this ingredient exhibited gel-like viscoelastic behavior with viscosity in the same order of magnitude as marketed products.
Skin damage caused by sodium lauryl sulfate was compensated by treatment with the developed formulation, and trans-epidermal water loss (TEWL) values showed clear decreasing values, evidencing improved skin barrier function.
Formulations containing this ingredient can potentially improve deficient skin barrier function as part of basic therapy of skin diseases and act as a superior alternative to marketed products comprising a minimum of well-chosen ingredients.

## 6. Linked PubMed Literature
- [PMID: 39282719] Development and characterization of topical formulation for maintenance therapy containing sorbitan monostearate with and without PEG-100-stearate — *Int J Cosmet Sci* (2025)