# DISTEARDIMONIUM HECTORITE (disteardimonium-hectorite) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/disteardimonium-hectorite
- **Standard INCI**: `DISTEARDIMONIUM HECTORITE`
- **KR MFDS Standard Name**: `다이스테아다이모늄헥토라이트`
- **CAS No.**: `97280-96-1`
- **EC / EINECS No.**: `306-493-1`
- **Origin**: `mineral`
- **Functions**: 점도조절제, 광안정제
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 다이스테아다이모늄헥토라이트 |
| KR (Former Names) | 디스테아디모늄헥토라이트 |
| EU (CosIng 1223/2009) | DISTEARDIMONIUM HECTORITE |
| US (PCPC / MoCRA INCI) | DISTEARDIMONIUM HECTORITE |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 二硬脂二甲铵锂蒙脱石 |
| JP (JCIA / MHLW QD) | DISTEARDIMONIUM HECTORITE  |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `2240`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **reported_use** (total): 0.04~28% — AH_build_w_tabs.pdf (null)
- **reported_use** (leave_on): 0.04~28% — AH_build_w_tabs.pdf (null)
- **reported_use** (rinse_off): 0.7~4% — AH_build_w_tabs.pdf (null)
- **reported_use** (eye): 0.02~15% — AH_build_w_tabs.pdf (null)
- **reported_use** (ingestion): 0.04~9% — AH_build_w_tabs.pdf (null)
- **reported_use** (spray): 0.1~2% — AH_build_w_tabs.pdf (null)
- **reported_use** (dermal): 0.07~28% — AH_build_w_tabs.pdf (null)
- **reported_use** (deodorant): 0.5~21% — AH_build_w_tabs.pdf (null)
- **reported_use** (hair): 0.3~0.3% — AH_build_w_tabs.pdf (null)
- **reported_use** (mucous): 0.04~9% — AH_build_w_tabs.pdf (null)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 4 – 10
- **Max Process Temp**: ≤ 85°C
- **Synergy Pairings**: PROPYLENE CARBONATE, ZINC OXIDE, TITANIUM DIOXIDE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE
- **Incompatibilities**: Fails to build yield value without high-shear dispersion and polar activator (e.g., Propylene Carbonate)

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: DISTEARDIMONIUM HECTORITE | CAS No.: 97280-96-1 | EC No.: 306-493-1
  - Origin: MINERAL | Functions: , 
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: cationic | CosIng/MFDS 
  - Official Regional Label Names: US [DISTEARDIMONIUM HECTORITE] · EU [DISTEARDIMONIUM HECTORITE] · CN [二硬脂二甲铵锂蒙脱石] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - 1-Octadecanaminium, N,N-dimethyl-N-octadecyl-, chloride, reaction products with hectorite 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. 2240 (二硬脂二甲铵锂蒙脱石))
  - 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): cir (reported_use, total): 0.04~28% / cir (reported_use, leave_on): 0.04~28% / cir (reported_use, rinse_off): 0.7~4%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [sun_color] Typical range: 0.3 ~ 3.0% (Median 1.2%, Ref: Elementis Bentone 38 / Bentone Gel TDS & CIR) — W/O sunscreen & color cosmetic thixotropic suspending agent
  - [anhydrous_balm] Typical range: 0.5 ~ 4.0% (Median 1.5%, Ref: Elementis Bentone Technical Guide) — Anhydrous oil-phase gelling & anti-sweating agent
  - [aqueous_serum] Typical range: 0.3 ~ 15.0% (Median 4.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=11, ELEMENTIS 10 · GRANT 1)) — Aqueous serum, toner & hydrogel matrix formulation component
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Oil Phase (High-shear homogenization + Polar Activator such as Propylene Carbonate or Ethanol)
  - Optimal pH Range: pH 4.0 ~ 10.0 | Max Process Temp: Max 85°C | Electrolyte Tolerance: HIGH
  - Incompatibility / Caution: Fails to build yield value without high-shear dispersion and polar activator (e.g., Propylene Carbonate)
  - Synergy Pairings: PROPYLENE CARBONATE, ZINC OXIDE, TITANIUM DIOXIDE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE | Reference Trade Names: Bentone® 38 V, Bentone Gel® VS-5PC V, Bentone Gel® MIO V
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 24335966 (2013, Int J Toxicol): Safety assessment of ammonium hectorites as used in cosmetics.

## 6. Linked PubMed Literature
- [PMID: 24335966] Safety assessment of ammonium hectorites as used in cosmetics. — *Int J Toxicol* (2013)