What are the official 7-track regulatory label names for POLYMETHYLSILSESQUIOXANE?

Standard label names are US PCPC INCI: 'POLYMETHYLSILSESQUIOXANE', EU CosIng: 'POLYMETHYLSILSESQUIOXANE', KR MFDS: 'POLYMETHYLSILSESQUIOXANE (KR MFDS Registered)', CN NMPA IECIC: '聚甲基倍半硅氧烷', and JP JCIA: 'POLYMETHYLSILSESQUIOXANE'.

Is POLYMETHYLSILSESQUIOXANE 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.

What is the typical formulation concentration and optimal pH window for POLYMETHYLSILSESQUIOXANE?

In aqueous_serum systems, POLYMETHYLSILSESQUIOXANE is typically formulated between 2% and 15% (median 5%), with an optimal stability window of pH 4–8.

What are the known formulation incompatibilities and synergy pairings for POLYMETHYLSILSESQUIOXANE?

Recommended synergy pairings include GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL. Key incompatibilities to avoid: Verify phase compatibility under extreme pH or high electrolyte loads.

Synthetic

POLYMETHYLSILSESQUIOXANE

Opacifying

[EU CosIng Official Definition] Polymer formed by hydrolysis and condensation of methyltrimethoxysilane

Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR

What is POLYMETHYLSILSESQUIOXANE (CAS 68554-70-1) in cosmetics and what are its global regulatory limits?

POLYMETHYLSILSESQUIOXANE (CAS No. 68554-70-1) is a verified cosmetic ingredient primarily functioning as Opacifying in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 2–15% within an optimal stability window of pH 4–8.

7-Track Official Regulatory Label Names Matrix

Primary Statutory Gazette Only · Zero Machine Translation

7-Track Official Statutory Label Names for POLYMETHYLSILSESQUIOXANE
Jurisdiction Track	Official Statutory Label Name	One-Click Copy
1. Korea (MFDS Standard Name)	POLYMETHYLSILSESQUIOXANE (KR MFDS Registered)
2. Korea Former Nomenclature History	Former KR Nomenclature Redirect Active	—
3. European Union (EU CosIng Glossary)	POLYMETHYLSILSESQUIOXANE
4. United States (US PCPC / MoCRA INCI)	POLYMETHYLSILSESQUIOXANE
5. US FDA OTC Monograph Active Name	— (Cosmetic Inactive / Non-OTC)	—
6. China (NMPA IECIC Standard Name)	聚甲基倍半硅氧烷
7. Japan (JCIA Standard / MHLW Quasi-Drug)	POLYMETHYLSILSESQUIOXANE (Standard INCI Reference)

Layer 1 — Statutory Regulatory Limits Across 6 Regions

Layer 1 Statutory Regulatory Limits Across 6 Regions for POLYMETHYLSILSESQUIOXANE
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 #3962
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

Aqueous Serum / Ampoulen=19

Min 2% · Q1 4% · Median 5% · Q3 5% · Max 15%

Emulsion / Creamn=33

Min 2% · Q1 2% · Median 4% · Q3 5% · Max 10%

Sunscreen / Colorn=47

Min 1% · Q1 3% · Median 5% · Q3 5.85% · Max 12%

Aqueous Serum / Ampoule — Aqueous serum, toner & hydrogel matrix formulation component

Verified Source: Global Starter Formulation Library Statistical Distribution (n=19, GRANT 19) (cir_safety) · GRANT 19

Typical Median: 5%

Layer 3 — Formulation Usage Guide (Quartiles n≥5) & Physicochemical Compatibility

Layer 3 Formulation Concentration Quartiles by Product Category for POLYMETHYLSILSESQUIOXANE
Formulation Group	Min – Q1 – Median – Q3 – Max (%)	Role & Mechanism	Source ID
Group A — Aqueous Toner / Serum / Ampoule	2% · 4% · 5% · 5% · 15%	Aqueous serum, toner & hydrogel matrix formulation component	Global Starter Formulation Library Statistical Distribution (n=19, GRANT 19)
Group B — O/W & W/O Emulsion / Lotion / Cream	2% · 2% · 4% · 5% · 10%	Emulsion cream & lotion structural / conditioning agent	Global Starter Formulation Library Statistical Distribution (n=33, GRANT 33)
Group D — Sunscreen (UV) / Color Cosmetics / Foundation	1% · 3% · 5% · 5.85% · 12%	Sun care & color cosmetics dispersion / sensory modifier	Global Starter Formulation Library Statistical Distribution (n=47, GRANT 47)

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

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

Water or glycol phase soluble/dispersible

Optimal Formulation pH Stability Window (0–14)pH 4.0 – 8.0

Outside pH 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.

Maximum Thermal Processing Limit (°C)≤ 50°C

Thermally stable up to 50°C during standard emulsification.

HLB Scale (0–20) & Colloidal Micelle / Lamellar Phase Simulator

O/W Oil-in-Water Micelle Emulsion (Lotion / Cream)

Simulate HLB:HLB 11.5

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.

+ GLYCERIN + CAPRYLIC/CAPRIC TRIGLYCERIDE + TOCOPHEROL

Nominative Trade Name References (Trademark Act Art. 90(1)(2))

POLYMETHYLSILSESQUIOXANE

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 Synthesis

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

■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: POLYMETHYLSILSESQUIOXANE | CAS No.: 68554-70-1 | EC No.: N/A - Origin: SYNTHETIC | Functions: - Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS - Official Regional Label Names: US [POLYMETHYLSILSESQUIOXANE] · EU [POLYMETHYLSILSESQUIOXANE] · CN [聚甲基倍半硅氧烷] · JP [-] · JP Quasi-Drug [-] ■ [2. Dermatological Mechanism of Action & Functional Role] - Polymer formed by hydrolysis and condensation of methyltrimethoxysilane 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. 3962 (聚甲基倍半硅氧烷)) - 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)] - [aqueous_serum] Typical range: 2.0 ~ 15.0% (Median 5.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=19, GRANT 19)) — Aqueous serum, toner & hydrogel matrix formulation component - [emulsion_cream] Typical range: 2.0 ~ 10.0% (Median 4.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=33, GRANT 33)) — Emulsion cream & lotion structural / conditioning agent - [sun_color] Typical range: 1.0 ~ 12.0% (Median 5.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=47, GRANT 47)) — 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: POLYMETHYLSILSESQUIOXANE ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 25427646 (2014, Biofabrication): Novel preparation of controlled porosity particle/fibre loaded scaffolds using a hybrid micro-fluidic and electrohydrody

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

Novel preparation of controlled porosity particle/fibre loaded scaffolds using a hybrid micro-fluidic and electrohydrodynamic technique. [PMID: 25427646 · 2014]

Parhizkar M, Sofokleous P, Stride E, Edirisinghe M · Biofabrication (2014)

The purpose of this research was to produce multi-dimensional scaffolds containing biocompatible particles and fibres. To achieve this, two techniques were combined and used: T-Junction microfluidics and electrohydrodynamic (EHD) processing. The former was used to form layers of monodispersed bovine serum albumin (BSA) bubbles, which upon drying formed porous scaffolds. By altering the T-Junction processing parameters, bubbles with different diameters were produced and hence the scaffold porosity could be controlled. EHD processing was used to spray or spin poly(lactic-co-glycolic) (PLGA), polymethysilsesquioxane (PMSQ) and collagen particles/fibres onto the scaffolds during their production and after drying. As a result, multifunctional BSA scaffolds with controlled porosity containing PLGA, PMSQ and collagen particles/fibres were obtained. Product morphology was studied by optical and scanning electron microscopy. These products have potential applications in many advanced biomedical, pharmaceutical and cosmetic fields e.g. bone regeneration, drug delivery, cosmetic cream lathers, facial scrubbing creams etc.

Frequently Asked Questions (AEO Position 0)

Q1. What are the official 7-track regulatory label names for POLYMETHYLSILSESQUIOXANE?: Standard label names are US PCPC INCI: 'POLYMETHYLSILSESQUIOXANE', EU CosIng: 'POLYMETHYLSILSESQUIOXANE', KR MFDS: 'POLYMETHYLSILSESQUIOXANE (KR MFDS Registered)', CN NMPA IECIC: '聚甲基倍半硅氧烷', and JP JCIA: 'POLYMETHYLSILSESQUIOXANE'.
Q2. Is POLYMETHYLSILSESQUIOXANE 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 POLYMETHYLSILSESQUIOXANE?: In aqueous_serum systems, POLYMETHYLSILSESQUIOXANE is typically formulated between 2% and 15% (median 5%), with an optimal stability window of pH 4–8.
Q4. What are the known formulation incompatibilities and synergy pairings for POLYMETHYLSILSESQUIOXANE?: Recommended synergy pairings include GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL. Key incompatibilities to avoid: Verify phase compatibility under extreme pH or high electrolyte loads.