Mineral / Inorganic
DISTEARDIMONIUM HECTORITE
Viscosity ControllingLight Stabilizer
[EU CosIng Official Definition] 1-Octadecanaminium, N,N-dimethyl-N-octadecyl-, chloride, reaction products with hectorite
Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR
What is DISTEARDIMONIUM HECTORITE (CAS 97280-96-1) in cosmetics and what are its global regulatory limits?
DISTEARDIMONIUM HECTORITE (CAS No. 97280-96-1) is a verified cosmetic ingredient primarily functioning as Viscosity Controlling, Light Stabilizer in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 0.3–3% within an optimal stability window of pH 4–10.
7-Track Official Regulatory Label Names Matrix
Primary Statutory Gazette Only · Zero Machine Translation| Jurisdiction Track | Official Statutory Label Name | One-Click Copy |
|---|---|---|
| 1. Korea (MFDS Standard Name) | DISTEARDIMONIUM HECTORITE (KR MFDS Registered) | |
| 2. Korea Former Nomenclature History | Former KR Nomenclature Redirect Active | — |
| 3. European Union (EU CosIng Glossary) | DISTEARDIMONIUM HECTORITE | |
| 4. United States (US PCPC / MoCRA INCI) | DISTEARDIMONIUM HECTORITE | |
| 5. US FDA OTC Monograph Active Name | — (Cosmetic Inactive / Non-OTC) | — |
| 6. China (NMPA IECIC Standard Name) | 二硬脂二甲铵锂蒙脱石 | |
| 7. Japan (JCIA Standard / MHLW Quasi-Drug) | DISTEARDIMONIUM HECTORITE (Standard INCI Reference) |
Layer 1 — Statutory Regulatory Limits Across 6 Regions
| Region | Status | Max Limit | Conditions & Statutory Source |
|---|---|---|---|
| Korea (MFDS) | Unregulated | GMP | Listed in official cosmetic inventory |
| Europe (EU) | Unregulated | GMP | Listed in official cosmetic inventory |
| United States (FDA) | Unregulated | GMP | Listed in official cosmetic inventory |
| China (NMPA) | Listed / Allowed | GMP | IECIC Entry #2240 |
| Japan (MHLW) | Unregulated | GMP | Listed in official cosmetic inventory |
| ASEAN (ACD) | Unregulated | GMP | Listed in official cosmetic inventory |
Layer 2 — Toxicological & Historical Safe Use Concentrations (CIR / SCCS / CN IECIC / IFRA)
“EU SCCS Safe Opinion Limit” is the toxicological safe threshold (MoS≥100), whereas “US CIR Reported Max Use” and “CN IECIC Historical Max Use” represent historical maximum concentrations in commercial products.
| Assessment Basis | Application Scope | Concentration Range | Verdict & Dossier Reference |
|---|---|---|---|
| US CIR Reported Max Use | total | 0.04~28% | Safe (MoS≥100)AH_build_w_tabs.pdf () |
| US CIR Reported Max Use | leave_on | 0.04~28% | Safe (MoS≥100)AH_build_w_tabs.pdf () |
| US CIR Reported Max Use | rinse_off | 0.7~4% | Safe (MoS≥100)AH_build_w_tabs.pdf () |
| US CIR Reported Max Use | eye | 0.02~15% | Safe (MoS≥100)AH_build_w_tabs.pdf () |
| US CIR Reported Max Use | ingestion | 0.04~9% | Safe (MoS≥100)AH_build_w_tabs.pdf () |
| US CIR Reported Max Use | spray | 0.1~2% | Safe (MoS≥100)AH_build_w_tabs.pdf () |
| US CIR Reported Max Use | dermal | 0.07~28% | Safe (MoS≥100)AH_build_w_tabs.pdf () |
| US CIR Reported Max Use | deodorant | 0.5~21% | Safe (MoS≥100)AH_build_w_tabs.pdf () |
| US CIR Reported Max Use | hair | 0.3~0.3% | Safe (MoS≥100)AH_build_w_tabs.pdf () |
| US CIR Reported Max Use | mucous | 0.04~9% | Safe (MoS≥100)AH_build_w_tabs.pdf () |
⚠️ Reference Only (Legal Disclaimer): The regulatory limits, ingredient names, and formulation ranges in this dictionary are provided for R&D reference only. Because official notices may be amended or data discrepancies may exist, users must verify the latest statutory text from the competent authority before product formulation, labeling, or commercialization. UNIZ LAB assumes no legal liability for the use of this information.
Interactive Quartile Box-Plot (Min–Q1–Median–Q3–Max)
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
Sunscreen / Colorn=168
Min 0.3% · Q1 0.75% · Median 1.2% · Q3 1.8% · Max 3%
Anhydrous Balm / Oiln=44
Min 0.5% · Q1 1% · Median 1.5% · Q3 2.5% · Max 4%
Aqueous Serum / Ampoulen=11
Min 0.3% · Q1 2% · Median 4% · Q3 9.5% · Max 15%
Sunscreen / Color — W/O sunscreen & color cosmetic thixotropic suspending agent
Verified Source: Elementis Bentone 38 / Bentone Gel TDS & CIR (cir_safety) · Elementis 88 · Grant 52 · Evonik 28
Typical Median: 1.2%
Layer 3 — Formulation Usage Guide (Quartiles n≥5) & Physicochemical Compatibility
| Formulation Group | Min – Q1 – Median – Q3 – Max (%) | Role & Mechanism | Source ID |
|---|---|---|---|
| Group D — Sunscreen (UV) / Color Cosmetics / Foundation | 0.3% · 0.75% · 1.2% · 1.8% · 3% | W/O sunscreen & color cosmetic thixotropic suspending agent | Elementis Bentone 38 / Bentone Gel TDS & CIR |
| Group E — Anhydrous Oil / Stick Balm / Lip Care | 0.5% · 1% · 1.5% · 2.5% · 4% | Anhydrous oil-phase gelling & anti-sweating agent | Elementis Bentone Technical Guide |
| Group A — Aqueous Toner / Serum / Ampoule | 0.3% · 2% · 4% · 9.5% · 15% | Aqueous serum, toner & hydrogel matrix formulation component | Global Starter Formulation Library Statistical Distribution (n=11, ELEMENTIS 10 · GRANT 1) |
Cutaneous Permeation Science (500 Dalton Rule)MW: Macro/Complex · LogP: N/A
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
Molecular Weight & LogP Permeation Diagnosis
Low Molecular Weight (320 Da ≤ 500 Da) — Passive Permeation Feasible
Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.
Estimated Target Depth
40–90 µm
Optimal Delivery System
Polyol Enhancer / Serum
Colloid Interface, pH Spectrum & Thermal Stability
Dispersible in oils/esters/silicones with polar activatorpH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Optimal Formulation pH Stability Window (0–14)pH 4.0 – 10.0
Outside pH 4–10, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Maximum Thermal Processing Limit (°C)≤ 85°C
Thermally stable up to 85°C during standard emulsification.
HLB Scale (0–20) & Colloidal Micelle / Lamellar Phase Simulator
O/W Oil-in-Water Micelle Emulsion (Lotion / Cream)
HLB 11.5
Biochemical Signaling & Mechanism Pathway
Cellular & Molecular Target Mechanism Flow
1. Epidermal Interaction→ Upregulation / Activation
Intercellular Lipid & Hydration Matrix
→TEWL Reduction & Barrier Conditioning
2. Homeostasis Modulation⊣ Inhibition / Blockade
Oxidative Stress (ROS) & Irritant Cascade
⊣Cutaneous Soothing & Homeostasis
Formulation Ontology Radial Graph
Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)
Interactive Node Guide
Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.
Nominative Trade Name References (Trademark Act Art. 90(1)(2))
Bentone® 38 VBentone Gel® VS-5PC VBentone Gel® MIO V
Trade names are provided strictly for descriptive identification of polymer/emulsifier grades under Article 90(1)(2) of the Trademark Act. All trademarks belong to their respective owners.
Academic & Toxicological Synthesis
Tier 1 SynthesisSynthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.
■ [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.
Linked Peer-Reviewed Literature (NIH PubMed) (1)
Safety assessment of ammonium hectorites as used in cosmetics. [PMID: 24335966 · 2013]
Becker LC, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG, Shank RC, Slaga TJ, Snyder PW, Andersen FA · Int J Toxicol (2013)
The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 4 ammonium hectorite compounds used in cosmetics: disteardimonium hectorite, dihydrogenated tallow benzylmonium hectorite, stearalkonium hectorite, and quaternium-18 hectorite. These ingredients function in cosmetics mainly as nonsurfactant suspending agents. The Panel reviewed available animal and human data and concluded that these ammonium hectorite compounds were safe as cosmetic ingredients in the practices of use and concentration as given in this safety assessment.
Frequently Asked Questions (AEO Position 0)
- Q1. What are the official 7-track regulatory label names for DISTEARDIMONIUM HECTORITE?
- Standard label names are US PCPC INCI: 'DISTEARDIMONIUM HECTORITE', EU CosIng: 'DISTEARDIMONIUM HECTORITE', KR MFDS: 'DISTEARDIMONIUM HECTORITE (KR MFDS Registered)', CN NMPA IECIC: '二硬脂二甲铵锂蒙脱石', and JP JCIA: 'DISTEARDIMONIUM HECTORITE'.
- Q2. Is DISTEARDIMONIUM HECTORITE restricted or permitted in EU, US, KR, CN, and JP cosmetics?
- Regulatory status summary across 6 jurisdictions — KR: none, EU: none, US: none, CN: allowed, JP: none, ASEAN: none.
- Q3. What is the typical formulation concentration and optimal pH window for DISTEARDIMONIUM HECTORITE?
- In sun_color systems, DISTEARDIMONIUM HECTORITE is typically formulated between 0.3% and 3% (median 1.2%), with an optimal stability window of pH 4–10.
- Q4. What are the known formulation incompatibilities and synergy pairings for DISTEARDIMONIUM HECTORITE?
- Recommended synergy pairings include PROPYLENE CARBONATE, ZINC OXIDE, TITANIUM DIOXIDE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE. Key incompatibilities to avoid: Fails to build yield value without high-shear dispersion and polar activator (e.g., Propylene Carbonate).