# DIMETHICONE (dimethicone) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/dimethicone
- **Standard INCI**: `DIMETHICONE`
- **KR MFDS Standard Name**: `다이메티콘`
- **CAS No.**: `63148-62-9`
- **EC / EINECS No.**: `N/A`
- **Origin**: `synthetic`
- **Functions**: 피부컨디셔닝제, 피부보호제, 소포제, 에모리엔트
- **Molecular Formula / MW**: `(C2H6OSi)n` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 다이메티콘 |
| KR (Former Names) | 디메치콘 |
| EU (CosIng 1223/2009) | DIMETHICONE |
| US (PCPC / MoCRA INCI) | DIMETHICONE |
| US (FDA OTC Monograph) | DIMETHICONE |
| CN (NMPA IECIC) | 聚二甲基硅氧烷 |
| JP (JCIA / MHLW QD) | ジメチコン (QD: メチルポリシロキサン) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `3732`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 85% — NMPA IECIC (2025) Entry 03477 (2025)
- **cn_iecic_max** (rinse_off): ≤ 30% — NMPA IECIC (2025) Entry 03477 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 2 – 12
- **Max Process Temp**: ≤ 95°C
- **Synergy Pairings**: CETEARYL OLIVATE, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE, C15-19 ALKANE
- **Incompatibilities**: High-viscosity grades require sufficient emulsifier structure to prevent silicone-oil phase separation

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: DIMETHICONE | CAS No.: 63148-62-9 | EC No.: N/A
  - Origin: SYNTHETIC | Functions: Skin Conditioning, , , 
  - Physicochemical Profile: Formula (C2H6OSi)n | MW /(Polymer/Complex) | /   | Ionic Nature: non-ionic | PubChem CID 24759
  - Official Regional Label Names: US [DIMETHICONE] · EU [DIMETHICONE] · CN [聚二甲基硅氧烷] · JP [ジメチコン] · JP Quasi-Drug [メチルポリシロキサン]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - DIMETHICONE functions primarily as , , ,  in dermatological and cosmetic formulations. 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. 3732 (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): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 85.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 30.0%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [emulsion_cream] Typical range: 0.5 ~ 10.0% (Median 2.0%, Ref: Dow XIAMETER PMX-200 100cSt TDS & CIR Assessment) — Anti-soaping agent, silky slip modifier & breathable skin protectant
  - [sun_color] Typical range: 1.0 ~ 20.0% (Median 5.0%, Ref: US FDA OTC Skin Protectant Monograph (1~30%) & CIR) — Water-repellent sunscreen & primer sensory modifier
  - [anhydrous_balm] Typical range: 0.5 ~ 65.0% (Median 7.5%, Ref: Global Starter Formulation Library Statistical Distribution (n=8, GRANT 5 · ELEMENTIS 2 · EVONIK 1)) — Anhydrous balm, oil & stick structural emollient
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Oil / Silicone Phase
  - Optimal pH Range: pH 2.0 ~ 12.0 | Max Process Temp: Max 95°C | Electrolyte Tolerance: HIGH
  - Incompatibility / Caution: High-viscosity grades require sufficient emulsifier structure to prevent silicone-oil phase separation
  - Synergy Pairings: CETEARYL OLIVATE, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE, C15-19 ALKANE | Reference Trade Names: XIAMETER™ PMX-200 Fluid (6cSt ~ 1000cSt), Belsil® DM
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 41373051 (2025, J Dent Child (Chic)): Fluoride Release, Enamel Fluoride Uptake and Dentin Tubule Occlusion From A Novel Dimethicone-Based Fluoride Varnish
  - PMID 39042700 (2024, PLoS Negl Trop Dis): A pilot study of dimeticone oils versus sodium carbonate treatment for tungiasis: A randomized cohort trial in Homa Bay 
  - 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

## 6. Linked PubMed Literature
- [PMID: 41373051] Fluoride Release, Enamel Fluoride Uptake and Dentin Tubule Occlusion From A Novel Dimethicone-Based Fluoride Varnish — *J Dent Child (Chic)* (2025)
- [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)
- [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: 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)