# KAOLIN (kaolin) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/kaolin
- **Standard INCI**: `KAOLIN`
- **KR MFDS Standard Name**: `카올린`
- **CAS No.**: `1332-58-7`
- **EC / EINECS No.**: `310-194-1`
- **Origin**: `mineral`
- **Functions**: 연마제, 흡수제, 색소, 고결방지제, 증량제, 불투명화제
- **Molecular Formula / MW**: `—` (— g/mol)

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

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `noted`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `2534`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`

- **EU** [noted]: — —  (Regulation (EC) No 1223/2009 Annex IV — via CosIng (EU Commission))

## 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: KAOLIN | CAS No.: 1332-58-7 | EC No.: 310-194-1
  - Origin: MINERAL | Functions: , , , , , 
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: non-ionic | CosIng/MFDS 
  - Official Regional Label Names: US [KAOLIN] · EU [KAOLIN] · CN [高岭土] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Naturally occurring substances, kaolin (CI 77004) 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: NOTED | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 2534 (高岭土))
  - [EU / COMPOSITION / noted]: 
  - 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)]
  - [cleanser_rinse] Typical range: 7.0 ~ 60.0% (Median 20.15%, Ref: Global Starter Formulation Library Statistical Distribution (n=6, GRANT 4 · EVONIK 1 · SEPPIC 1)) — Rinse-off cleanser & surfactant system modifier
  - [emulsion_cream] Typical range: 2.0 ~ 19.0% (Median 7.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=7, SEPPIC 4 · GRANT 3)) — Emulsion cream & lotion structural / conditioning agent
  - [sun_color] Typical range: 1.5 ~ 5.5% (Median 1.9%, Ref: Global Starter Formulation Library Statistical Distribution (n=5, GRANT 5)) — 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: KAOLIN
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 28943206 (2017, Int J Pharm): Kaolinite in pharmaceutics and biomedicine.
  - PMID 36460116 (2023, Sci Total Environ): Sorption of cosmetic and personal care polymer ingredients to iron oxides, clay minerals and soil clays: An environmenta
  - PMID 35458768 (2022, Molecules): Preparation of Chitosan/Clay Composites for Safe and Effective Hemorrhage Control.

## 6. Linked PubMed Literature
- [PMID: 28943206] Kaolinite in pharmaceutics and biomedicine. — *Int J Pharm* (2017)
- [PMID: 36460116] Sorption of cosmetic and personal care polymer ingredients to iron oxides, clay minerals and soil clays: An environmental perspective. — *Sci Total Environ* (2023)
- [PMID: 35458768] Preparation of Chitosan/Clay Composites for Safe and Effective Hemorrhage Control. — *Molecules* (2022)
- [PMID: 42313106] Amended Safety Assessment of Naturally-Sourced Clays as Used in Cosmetics — *Int J Toxicol* (2026)
- [PMID: 41887151] Integrated γ/α spectrometry of natural radioactivity and PHITS Monte Carlo dosimetric assessment of Balengou kaolin, Cameroon — *J Environ Radioact* (2026)
- [PMID: 41867590] Kaolin-Gallic Acid Functionalized Gamma-Chitosan/Alginate Beads: A Novel Material for Chlorhexidine and Cetylpyridinium Elimination from Dental Effluents — *ACS Omega* (2026)
- [PMID: 41478157] Regulating Sepia melanin agglomerates using tailored kaolinite to accelerate skin wound healing — *Colloids Surf B Biointerfaces* (2026)
- [PMID: 39684902] Antimicrobial Mixture Based on Micronized Kaolinite and Ziziphora Essential Oil as a Promising Formulation for the Management of Infected Wounds — *Int J Mol Sci* (2024)
- [PMID: 39340383] Management of trihalomethanes in water by ZnO@kaolinite composite: integrated experimental and modeling studies — *J Water Health* (2024)
- [PMID: 42076771] Multimodal Topical Formulations Combining Synthetic Anti-Inflammatory Agents, Levofloxacin, and Plant Extracts for Veterinary Wound and Inflammation Care: In Vivo Efficacy — *Vet Sci* (2026)
- [PMID: 40399375] Removal of methylene blue from synthetic industrial wastewater by using geopolymer prepared from partially dealuminated metakaolin — *Sci Rep* (2025)
- [PMID: 40216795] Preparation and characterization of nano-silver/graphene oxide antibacterial skin dressing — *Sci Rep* (2025)
- [PMID: 38348937] Development of toothpaste formulations containing mineral clays as abrasive agents and their effects on the physical properties of dental enamel — *J Esthet Restor Dent* (2024)
- [PMID: 38009030] Comprehensive assessment of the efficacy and safety of a clay mask in oily and acne skin — *Skin Res Technol* (2023)
- [PMID: 37775628] Induction of systemic resistance in Solanum lycopersicum and Capsicum annum seedlings against Fusarium wilt by Streptomyces bioformulations — *Environ Sci Pollut Res Int* (2023)