# BIS-PEG-12 DIMETHICONE (bis-peg-12-dimethicone) — Global Cosmetic Regulatory & Formulation Monograph - **Canonical URL**: https://www.inciname.com/en/ingredients/bis-peg-12-dimethicone - **Standard INCI**: `BIS-PEG-12 DIMETHICONE` - **KR MFDS Standard Name**: `비스-피이지-12다이메티콘` - **CAS No.**: `102783-01-7` - **EC / EINECS No.**: `N/A` - **Origin**: `synthetic` - **Functions**: 모발컨디셔닝제, 피부컨디셔닝제, 에모리엔트 - **Molecular Formula / MW**: `—` (— g/mol) ## 1. 7-Track Official Regulatory Label Names | Track | Official Label Nomenclature | | :--- | :--- | | KR (MFDS Standard) | 비스-피이지-12다이메티콘 | | KR (Former Names) | — | | EU (CosIng 1223/2009) | BIS-PEG-12 DIMETHICONE | | US (PCPC / MoCRA INCI) | BIS-PEG-12 DIMETHICONE | | US (FDA OTC Monograph) | — | | CN (NMPA IECIC) | 双-PEG-12 聚二甲基硅氧烷 | | JP (JCIA / MHLW QD) | BIS-PEG-12 DIMETHICONE | ## 2. Layer 1 — Global 6-Region Statutory Summary - **KR (MFDS)**: `none` - **EU (1223/2009)**: `none` - **US (FDA/MoCRA)**: `none` - **CN (NMPA IECIC)**: `allowed` (Entry: `6210`) - **JP (MHLW)**: `none` - **ASEAN (ACD)**: `none` ## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations - Listed within general cosmetic GMP safety thresholds. ## 4. Layer 3 — Formulation Quartiles & Compatibility - **Optimal pH Window**: 4 – 8 - **Max Process Temp**: ≤ 50°C - **Synergy Pairings**: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL - **Incompatibilities**: Verify phase compatibility under extreme pH or high electrolyte loads ## 5. Academic Monograph ■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: BIS-PEG-12 DIMETHICONE | CAS No.: 102783-01-7 | EC No.: N/A - Origin: SYNTHETIC | Functions: , , - Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS - Official Regional Label Names: US [BIS-PEG-12 DIMETHICONE] · EU [BIS-PEG-12 DIMETHICONE] · CN [双-PEG-12 聚二甲基硅氧烷] · JP [-] · JP Quasi-Drug [-] ■ [2. Dermatological Mechanism of Action & Functional Role] - Bis-PEG-12 Dimethicone is Dimethicone end-blocked with average of 12 moles of ethylene oxide 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. 6210 (双-PEG-12 聚二甲基硅氧烷)) - 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: 3.0 ~ 20.0% (Median 4.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=6, GRANT 6)) — Aqueous serum, toner & hydrogel matrix formulation component - [cleanser_rinse] Typical range: 1.0 ~ 10.0% (Median 2.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=7, GRANT 7)) — Rinse-off cleanser & surfactant system 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: BIS-PEG-12 DIMETHICONE ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 42019729 (2026, J Am Acad Dermatol): Plastic in dermatology: Impacts on human health, skin disease, and the contribution of personal care product use to envi - PMID 41835609 (2026, ACS Omega): Tailoring the Stability of W/O/W Liquid Foundations: A Comparative Study of Polyglycerol-Based W/O Emulsifiers - PMID 41373051 (2025, J Dent Child (Chic)): Fluoride Release, Enamel Fluoride Uptake and Dentin Tubule Occlusion From A Novel Dimethicone-Based Fluoride Varnish ## 6. Linked PubMed Literature - [PMID: 42019729] Plastic in dermatology: Impacts on human health, skin disease, and the contribution of personal care product use to environmental pollution — *J Am Acad Dermatol* (2026) - [PMID: 41835609] Tailoring the Stability of W/O/W Liquid Foundations: A Comparative Study of Polyglycerol-Based W/O Emulsifiers — *ACS Omega* (2026) - [PMID: 41373051] Fluoride Release, Enamel Fluoride Uptake and Dentin Tubule Occlusion From A Novel Dimethicone-Based Fluoride Varnish — *J Dent Child (Chic)* (2025) - [PMID: 40643063] Skin cleansers and leave-on product interventions for preventing incontinence-associated dermatitis in adults — *Cochrane Database Syst Rev* (2025) - [PMID: 40333845] Cleansing Mechanisms and Efficacy on Artificial Skin — *Molecules* (2025) - [PMID: 39741562] The Role of Moisturizer Containing Anti-inflammatory on Skin Hydration in Mild-Moderate Atopic Dermatitis Patients — *Dermatol Res Pract* (2024) - [PMID: 39684059] Structural Similarity-Induced Inter-Component Interaction in Silicone Polymer-Based Composite Sunscreen Film for Enhanced UV Protection — *Polymers (Basel)* (2024) - [PMID: 39588819] Characteristics of Diaper Dermatitis in Patients Aged 0-24 Months After Congenital Heart Disease and the Effects of a Diaper Dermatitis Care Bundle: A Comparison of 2 Groups — *J Wound Ostomy Continence Nurs* (2024) - [PMID: 39564575] A New Prescription Emollient Device (PED) For Psoriasis of Sensitive Areas and Folds: A Randomized Prospective Open Trial — *Psoriasis (Auckl)* (2024) - [PMID: 39349693] Impact of Different Packaging Configurations on A Topical Cream Product — *Pharm Res* (2024) - [PMID: 39045851] Safety Assessment of Vinylpyrrolidone Polymers as Used in Cosmetics — *Int J Toxicol* (2024) - [PMID: 39042700] A pilot study of dimeticone oils versus sodium carbonate treatment for tungiasis: A randomized cohort trial in Homa Bay County, Kenya — *PLoS Negl Trop Dis* (2024)