Synthetic
POLYGLYCERYL-6 STEARATE
Emollient
[EU CosIng Official Definition] ester of hexaglycerol and stearic acid
Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR
What is POLYGLYCERYL-6 STEARATE (CAS 95461-65-7) in cosmetics and what are its global regulatory limits?
POLYGLYCERYL-6 STEARATE (CAS No. 95461-65-7) is a verified cosmetic ingredient primarily functioning as Emollient in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 1.5–4% within an optimal stability window of pH 4–8.5.
7-Track Official Regulatory Label Names Matrix
Primary Statutory Gazette Only · Zero Machine Translation| Jurisdiction Track | Official Statutory Label Name | One-Click Copy |
|---|---|---|
| 1. Korea (MFDS Standard Name) | POLYGLYCERYL-6 STEARATE (KR MFDS Registered) | |
| 2. Korea Former Nomenclature History | — | — |
| 3. European Union (EU CosIng Glossary) | POLYGLYCERYL-6 STEARATE | |
| 4. United States (US PCPC / MoCRA INCI) | POLYGLYCERYL-6 STEARATE | |
| 5. US FDA OTC Monograph Active Name | — (Cosmetic Inactive / Non-OTC) | — |
| 6. China (NMPA IECIC Standard Name) | 聚甘油-6 硬脂酸酯 | |
| 7. Japan (JCIA Standard / MHLW Quasi-Drug) | POLYGLYCERYL-6 STEARATE (Standard INCI Reference) |
Layer 1 — Statutory Regulatory Limits Across 6 Regions
| Region | Status | Max Limit | Conditions & Statutory Source |
|---|---|---|---|
| Korea (MFDS) | Unregulated | GMP | Listed in official cosmetic inventory |
| Europe (EU) | Unregulated | GMP | Listed in official cosmetic inventory |
| United States (FDA) | Unregulated | GMP | Listed in official cosmetic inventory |
| China (NMPA) | Listed / Allowed | GMP | IECIC Entry #3875 |
| Japan (MHLW) | Unregulated | GMP | Listed in official cosmetic inventory |
| ASEAN (ACD) | Unregulated | GMP | Listed in official cosmetic inventory |
⚠️ 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.
Interactive Quartile Box-Plot (Min–Q1–Median–Q3–Max)
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
Emulsion / Creamn=82
Min 1.5% · Q1 2% · Median 2.5% · Q3 3.2% · Max 4%
Sunscreen / Colorn=46
Min 1.5% · Q1 2% · Median 2.8% · Q3 3.5% · Max 4%
Emulsion / Cream — Low-viscosity milky toner & lotion PEG-free O/W emulsifier
Verified Source: Evonik TEGO Care PBS 6 TDS & Formulation Library (cir_safety) · Evonik 76 · Croda 6
Typical Median: 2.5%
Layer 3 — Formulation Usage Guide (Quartiles n≥5) & Physicochemical Compatibility
| Formulation Group | Min – Q1 – Median – Q3 – Max (%) | Role & Mechanism | Source ID |
|---|---|---|---|
| Group B — O/W & W/O Emulsion / Lotion / Cream | 1.5% · 2% · 2.5% · 3.2% · 4% | Low-viscosity milky toner & lotion PEG-free O/W emulsifier | Evonik TEGO Care PBS 6 TDS & Formulation Library |
| Group D — Sunscreen (UV) / Color Cosmetics / Foundation | 1.5% · 2% · 2.8% · 3.5% · 4% | O/W sun-serum & high-UV-load emulsifier | Evonik TEGO Care PBS 6 Technical Dossier |
Cutaneous Permeation Science (500 Dalton Rule)MW: Macro/Complex · LogP: N/A
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
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
Oil phase (melts at ~55°C)pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Optimal Formulation pH Stability Window (0–14)pH 4.0 – 8.5
Outside pH 4–8.5, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Maximum Thermal Processing Limit (°C)≤ 85°C
Thermally stable up to 85°C during standard emulsification.
HLB Scale (0–20) & Colloidal Micelle / Lamellar Phase Simulator
O/W Oil-in-Water Micelle Emulsion (Lotion / Cream)
HLB 13.0
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
Formulation Ontology Radial Graph
Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)
Interactive Node Guide
Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.
Nominative Trade Name References (Trademark Act Art. 90(1)(2))
TEGO® Care PBS 6
Trade names are provided strictly for descriptive identification of polymer/emulsifier grades under Article 90(1)(2) of the Trademark Act. All trademarks belong to their respective owners.
Academic & Toxicological Synthesis
Tier 1 SynthesisSynthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.
■ [1. Chemical Identity & International Labeling Nomenclature]
- INCI Name: POLYGLYCERYL-6 STEARATE | CAS No.: 95461-65-7 | EC No.: N/A
- Origin: SYNTHETIC | Functions:
- Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS
- Official Regional Label Names: US [POLYGLYCERYL-6 STEARATE] · EU [POLYGLYCERYL-6 STEARATE] · CN [聚甘油-6 硬脂酸酯] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
- ester of hexaglycerol and stearic acid 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. 3875 (聚甘油-6 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): Quantum satis (QS) within standard cosmetic safety margins
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
- [emulsion_cream] Typical range: 1.5 ~ 4.0% (Median 2.5%, Ref: Evonik TEGO Care PBS 6 TDS & Formulation Library) — Low-viscosity milky toner & lotion PEG-free O/W emulsifier
- [sun_color] Typical range: 1.5 ~ 4.0% (Median 2.8%, Ref: Evonik TEGO Care PBS 6 Technical Dossier) — O/W sun-serum & high-UV-load emulsifier
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
- Addition Phase: Oil Phase (Heat to 75~80°C with Polyglyceryl-6 Behenate)
- Optimal pH Range: pH 4.0 ~ 8.5 | Max Process Temp: Max 85°C | Electrolyte Tolerance: HIGH
- Incompatibility / Caution: Highly resilient to organic acid preservatives and water-soluble UV filters
- Synergy Pairings: POLYGLYCERYL-6 BEHENATE, CETEARYL ALCOHOL, GLYCERYL STEARATE | Reference Trade Names: TEGO® Care PBS 6
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
- Validated against official regulatory compendia (MFDS/CosIng/CIR/SCCS) and physicochemical standards.
Linked Peer-Reviewed Literature (NIH PubMed) (0)
Statutory toxicology dossier verified via CosIng / MFDS / CIR compendia.
Frequently Asked Questions (AEO Position 0)
- Q1. What are the official 7-track regulatory label names for POLYGLYCERYL-6 STEARATE?
- Standard label names are US PCPC INCI: 'POLYGLYCERYL-6 STEARATE', EU CosIng: 'POLYGLYCERYL-6 STEARATE', KR MFDS: 'POLYGLYCERYL-6 STEARATE (KR MFDS Registered)', CN NMPA IECIC: '聚甘油-6 硬脂酸酯', and JP JCIA: 'POLYGLYCERYL-6 STEARATE'.
- Q2. Is POLYGLYCERYL-6 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 POLYGLYCERYL-6 STEARATE?
- In emulsion_cream systems, POLYGLYCERYL-6 STEARATE is typically formulated between 1.5% and 4% (median 2.5%), with an optimal stability window of pH 4–8.5.
- Q4. What are the known formulation incompatibilities and synergy pairings for POLYGLYCERYL-6 STEARATE?
- Recommended synergy pairings include POLYGLYCERYL-6 BEHENATE, CETEARYL ALCOHOL, GLYCERYL STEARATE. Key incompatibilities to avoid: Highly resilient to organic acid preservatives and water-soluble UV filters.