# SILICA (silica) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/silica
- **Standard INCI**: `SILICA`
- **KR MFDS Standard Name**: `실리카`
- **CAS No.**: `7631-86-9`
- **EC / EINECS No.**: `231-545-4`
- **Origin**: `mineral`
- **Functions**: 연마제, 흡수제, 불투명화제, 고결방지제, 증량제, 점도조절제
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 실리카 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | SILICA |
| US (PCPC / MoCRA INCI) | SILICA |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 硅石 |
| JP (JCIA / MHLW QD) | SILICA  |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `2648`)
- **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: SILICA | CAS No.: 7631-86-9 | EC No.: 231-545-4
  - Origin: MINERAL | Functions: , , , , , 
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: non-ionic | CosIng/MFDS 
  - Official Regional Label Names: US [SILICA] · EU [SILICA] · CN [硅石] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Silicon dioxide Classified under origin 'mineral', 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. 2648 (硅石))
  - 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: 0.2 ~ 2.0% (Median 2.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=5, SEPPIC 3 · GRANT 2)) — Aqueous serum, toner & hydrogel matrix formulation component
  - [emulsion_cream] Typical range: 0.2 ~ 5.0% (Median 1.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=16, GRANT 7 · SEPPIC 6 · EVONIK 2 · ELEMENTIS 1)) — Emulsion cream & lotion structural / conditioning agent
  - [sun_color] Typical range: 0.1 ~ 15.0% (Median 0.625%, Ref: Global Starter Formulation Library Statistical Distribution (n=42, GRANT 36 · EVONIK 5 · SEPPIC 1)) — 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: SILICA
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 42284667 (2026, J Chromatogr A): A deep eutectic solvent-assisted green synthesis of advanced three-dimensional covalent organic framework based stationa
  - PMID 42177389 (2026, Chem Asian J): Nature-Inspired Hybrid Photocatalytic System for Degradation of Persistent Organic Pollutants, Including Pharmaceutical 
  - PMID 42168491 (2026, Sci Rep): Examining the immunomodulatory role of nanoparticles on mast cell activation

## 6. Linked PubMed Literature
- [PMID: 42284667] A deep eutectic solvent-assisted green synthesis of advanced three-dimensional covalent organic framework based stationary phase for dual-mode liquid chromatography — *J Chromatogr A* (2026)
- [PMID: 42177389] Nature-Inspired Hybrid Photocatalytic System for Degradation of Persistent Organic Pollutants, Including Pharmaceutical Remains Using Solar-Driven Continuous Flow Reactor — *Chem Asian J* (2026)
- [PMID: 42168491] Examining the immunomodulatory role of nanoparticles on mast cell activation — *Sci Rep* (2026)
- [PMID: 42153630] Engineered 3D-Lattice Microneedle Array Patches for Enhanced Nanovaccine Delivery to Dendritic Cells in Cancer Immunotherapy — *ACS Nano* (2026)
- [PMID: 42124425] Tailorable Janus Silica Particles with Morphological and Functional Anisotropy for Enhanced Oil-Water Emulsion Stability — *Langmuir* (2026)
- [PMID: 42272942] Synergistic and multi-targeting efficacy of Acalypha wilkesiana and Mirabilis jalapa: an integrated in-vitro and in-silico investigation against Staphylococcus aureus and Pseudomonas aeruginosa — *In Silico Pharmacol* (2026)
- [PMID: 42256885] A BAI1-PSTB-Hydrogel promotes diabetic wound healing by targeting mtDNA leakage and the cGAS-STING axis to alleviate endothelial senescence — *Bioact Mater* (2026)
- [PMID: 42252931] Emerging trends of nanotechnology-based drug delivery for wound healing — *J Drug Target* (2026)
- [PMID: 42214520] pH-responsive alginate/gelatin-based hydrogel with antibacterial and antioxidant properties for enhanced infected wound healing — *Int J Biol Macromol* (2026)
- [PMID: 42201084] Vehicle Cabins as Hotspots of Brominated Flame Retardants: Legacy-Replacement Profiles, Sources, and Human Exposure in a Hot-Climate Environment — *J Xenobiot* (2026)
- [PMID: 42093738] A multifunctional nano-hydrogel attenuates skin photoaging via regulating ECM microenvironment homeostasis — *Mater Today Bio* (2026)
- [PMID: 42078001] From Silicosis to Systemic Sclerosis: Erasmus Syndrome in a Young Galamseyer-Case Report — *Case Rep Dermatol Med* (2026)