Ingredient Dictionary/peg-100-stearate/PEG-100 STEARATE
Tier 2 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
Synthetic

PEG-100 STEARATE

Cleansing
[EU CosIng Official Definition] Poly(oxy-1,2-ethanediyl), .alpha.-(1-oxooctadecyl)-.omega.-hydroxy- (100 mol EO average molar ratio)
Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR

What is PEG-100 STEARATE (CAS 9004-99-3) in cosmetics and what are its global regulatory limits?

PEG-100 STEARATE (CAS No. 9004-99-3) is a verified cosmetic ingredient primarily functioning as Cleansing in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 0.1–5.0% within an optimal stability window of pH 4.5–7.5.

7-Track Official Regulatory Label Names Matrix

Primary Statutory Gazette Only · Zero Machine Translation
7-Track Official Statutory Label Names for PEG-100 STEARATE
Jurisdiction TrackOfficial Statutory Label NameOne-Click Copy
1. Korea (MFDS Standard Name)PEG-100 STEARATE (KR MFDS Registered)
2. Korea Former Nomenclature History——
3. European Union (EU CosIng Glossary)PEG-100 STEARATE
4. United States (US PCPC / MoCRA INCI)PEG-100 STEARATE
5. US FDA OTC Monograph Active Name— (Cosmetic Inactive / Non-OTC)—
6. China (NMPA IECIC Standard Name)PEG-100 硬脂酸酯
7. Japan (JCIA Standard / MHLW Quasi-Drug)PEG-100 STEARATE (Standard INCI Reference)

Layer 1 — Statutory Regulatory Limits Across 6 Regions

Layer 1 Statutory Regulatory Limits Across 6 Regions for PEG-100 STEARATE
RegionStatusMax LimitConditions & Statutory Source
Korea (MFDS)UnregulatedGMPListed in official cosmetic inventory
Europe (EU)UnregulatedGMPListed in official cosmetic inventory
United States (FDA)UnregulatedGMPListed in official cosmetic inventory
China (NMPA)Listed / AllowedGMPIECIC Entry #494
Japan (MHLW)UnregulatedGMPListed in official cosmetic inventory
ASEAN (ACD)UnregulatedGMPListed in official cosmetic inventory

Layer 2 — Toxicological & Historical Safe Use Concentrations (CIR / SCCS / CN IECIC / IFRA)

“EU SCCS Safe Opinion Limit” is the toxicological safe threshold (MoS≥100), whereas “US CIR Reported Max Use” and “CN IECIC Historical Max Use” represent historical maximum concentrations in commercial products.

Layer 2 Toxicological & Historical Safe Use Concentrations for PEG-100 STEARATE
Assessment BasisApplication ScopeConcentration RangeVerdict & Dossier Reference
CN IECIC Historical Max Useleave_on≤ 10%Safe (MoS≥100)NMPA IECIC (2025) Entry 00548 (2025)
CN IECIC Historical Max Userinse_off≤ 6%Safe (MoS≥100)NMPA IECIC (2025) Entry 00548 (2025)
⚠️ Reference Only (Legal Disclaimer): The regulatory limits, ingredient names, and formulation ranges in this dictionary are provided for R&D reference only. Because official notices may be amended or data discrepancies may exist, users must verify the latest statutory text from the competent authority before product formulation, labeling, or commercialization. UNIZ LAB assumes no legal liability for the use of this information.
Cutaneous Permeation Science (500 Dalton Rule)MW: Macro/Complex · LogP: N/A

Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery

Stratum Corneum (Brick & Mortar Barrier · 10–20 µm)500 Da Molecular Weight Cutoff BarrierViable Epidermis (Keratinocytes & Melanocytes · 50–100 µm)Target for Brightening (Tyrosinase/Melanosome) & Barrier LipidsPapillary Dermis (Fibroblasts & ECM Collagen · 150–300 µm)Target for Collagen I/III Synthesis, Peptides, PDRN & ExosomesEpidermal Passive Permeation (<500 Da)
Molecular Weight & LogP Permeation Diagnosis
Low Molecular Weight (320 Da ≤ 500 Da) — Passive Permeation Feasible

Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.

Estimated Target Depth
40–90 µm
Optimal Delivery System
Polyol Enhancer / Serum
Colloid Interface, pH Spectrum & Thermal Stability

pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior

Optimal Formulation pH Stability Window (0–14)pH 4.5 – 7.5
0245.5791114

Outside pH 4.5–7.5, risk of hydrolysis, viscosity loss, or ionic dissociation increases.

Maximum Thermal Processing Limit (°C)≤ 70°C
25°C45°C60°C75°C85°C100°C

Thermally stable up to 70°C during standard emulsification.

HLB Scale (0–20) & Colloidal Micelle / Lamellar Phase Simulator
O/W Oil-in-Water Micelle Emulsion (Lotion / Cream)
HLB 11.5
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)O/W Droplet
Biochemical Signaling & Mechanism Pathway

Cellular & Molecular Target Mechanism Flow

1. Epidermal Interaction→ Upregulation / Activation
Intercellular Lipid & Hydration Matrix
→
TEWL Reduction & Barrier Conditioning
2. Homeostasis Modulation⊣ Inhibition / Blockade
Oxidative Stress (ROS) & Irritant Cascade
⊣
Cutaneous Soothing & Homeostasis

Academic & Toxicological Synthesis

Tier 2 Synthesis

Synthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.

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.

Linked Peer-Reviewed Literature (NIH PubMed) (1)

Development and characterization of topical formulation for maintenance therapy containing sorbitan monostearate with and without PEG-100-stearate [PMID: 39282719 · 2025]
Schoenfelder H, Wiedemann Y, Lunter DJ · Int J Cosmet Sci (2025)

Basic therapy is an integral part of the treatment of chronic skin diseases. However, the formulation of skin products should be analysed with respect to the physical stability and tolerance by the patients before applying them to diseased skin. In particular, the suitability of the formulation for use on damaged skin should be taken into consideration so that no exacerbation of the condition is caused. The following approach investigated two formulations with the emulsifier sorbitan monostearate and one with the addition of polyethylene glycol 100 stearyl ether. The characterization included rheology, macroscopic and microscopic cream analysis compared to marketed products for basic therapy. Pyranine staining of stratum corneum (SC) and trans-epidermal water loss (TEWL) measurements were performed with ex&#xa0;vivo porcine SC to asses skin barrier function. The rheological characterization showed a gel-like, viscoelastic behaviour of the formulations and a viscosity in the same order of magnitude as the marketed products. Staining with pyranine revealed that skin damage caused by sodium lauryl sulfate was compensated by treatment with the developed formulations. Following the same trend, TEWL results clearly showed decreasing values, which evidence improved skin barrier function. In conclusion, the developed sorbitan monostearate formulations can potentially improve deficient skin barrier function as a part of basic therapy of skin diseases and act as a superior alternative to market products comprising a minimum of well-chosen ingredients. la th&#xe9;rapie de base fait partie int&#xe9;grante du traitement des maladies chroniques de la peau. Cependant, la formulation des produits pour la peau doit &#xea;tre analys&#xe9;e en termes de stabilit&#xe9; physique et de tol&#xe9;rance par les patients avant de les appliquer sur la peau malade. En particulier, il convient de prendre en compte l'ad&#xe9;quation de la formulation &#xe0; &#xea;tre utilis&#xe9;e sur une peau l&#xe9;s&#xe9;e afin d'&#xe9;viter toute exacerbation de l'affection. M&#xc9;THODES: l'approche suivante a &#xe9;tudi&#xe9; deux formulations avec l'&#xe9;mulsifiant monost&#xe9;arate de sorbitane et une autre avec l'ajout d'&#xe9;ther de st&#xe9;aryle de poly&#xe9;thyl&#xe8;ne glycol 100. La caract&#xe9;risation comprenait la rh&#xe9;ologie, l'analyse macroscopique et microscopique de la cr&#xe8;me par rapport aux produits commercialis&#xe9;s pour la th&#xe9;rapie de base. Une coloration &#xe0; la pyranine de la couche corn&#xe9;e et des mesures de la perte d'eau trans&#xe9;pidermique ont &#xe9;t&#xe9; effectu&#xe9;es avec des couches corn&#xe9;es ex&#xa0;vivo de porc pour &#xe9;valuer la fonction de barri&#xe8;re cutan&#xe9;e. R&#xc9;SULTATS: la caract&#xe9;risation rh&#xe9;ologique a montr&#xe9; un comportement visco&#xe9;lastique de type gel des formulations et une viscosit&#xe9; du m&#xea;me ordre de grandeur que les produits commercialis&#xe9;s. La coloration &#xe0; la pyranine a r&#xe9;v&#xe9;l&#xe9; que les l&#xe9;sions cutan&#xe9;es caus&#xe9;es par le laurylsulfate de sodium &#xe9;taient compens&#xe9;es par le traitement avec les formulations d&#xe9;velopp&#xe9;es. Suivant la m&#xea;me tendance, les r&#xe9;sultats de la perte d'eau trans&#xe9;pidermique ont clairement montr&#xe9; des valeurs en baisse, ce qui t&#xe9;moigne de l'am&#xe9;lioration de la fonction de barri&#xe8;re cutan&#xe9;e. en conclusion, les formulations de monost&#xe9;arate de sorbitane d&#xe9;velopp&#xe9;es peuvent potentiellement am&#xe9;liorer la fonction de barri&#xe8;re cutan&#xe9;e d&#xe9;ficiente dans le cadre d'une th&#xe9;rapie de base des maladies de la peau et constituer une alternative sup&#xe9;rieure.

Frequently Asked Questions (AEO Position 0)

Q1. What are the official 7-track regulatory label names for PEG-100 STEARATE?
Standard label names are US PCPC INCI: 'PEG-100 STEARATE', EU CosIng: 'PEG-100 STEARATE', KR MFDS: 'PEG-100 STEARATE (KR MFDS Registered)', CN NMPA IECIC: 'PEG-100 硬脂酸酯', and JP JCIA: 'PEG-100 STEARATE'.
Q2. Is PEG-100 STEARATE restricted or permitted in EU, US, KR, CN, and JP cosmetics?
Regulatory status summary across 6 jurisdictions — KR: none, EU: none, US: none, CN: allowed, JP: none, ASEAN: none.
Q3. What is the typical formulation concentration and optimal pH window for PEG-100 STEARATE?
Formulate within pH 4.5–7.5 and max process temperature ≤70°C.
Q4. What are the known formulation incompatibilities and synergy pairings for PEG-100 STEARATE?
Recommended synergy pairings include Panthenol, Ceramide NP, Hydrolyzed Sponge. Key incompatibilities to avoid: Extreme pH or strong oxidizing agents.