Synthetic
HYDROXYECTOIN
pH AdjusterSkin ConditioningBufferingEmollient
Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR
What is HYDROXYECTOIN (CAS 165542-15-4) in cosmetics and what are its global regulatory limits?
HYDROXYECTOIN (CAS No. 165542-15-4) is a verified cosmetic ingredient primarily functioning as pH Adjuster, Skin Conditioning, Buffering in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 0.1–5.0% within an optimal stability window of pH 4.5–7.5.
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) | HYDROXYECTOIN (KR MFDS Registered) | |
| 2. Korea Former Nomenclature History | — | — |
| 3. European Union (EU CosIng Glossary) | HYDROXYECTOIN | |
| 4. United States (US PCPC / MoCRA INCI) | HYDROXYECTOIN | |
| 5. US FDA OTC Monograph Active Name | — (Cosmetic Inactive / Non-OTC) | — |
| 6. China (NMPA IECIC Standard Name) | Unlisted in CN NMPA IECIC (Do Not Machine-Translate) | — |
| 7. Japan (JCIA Standard / MHLW Quasi-Drug) | HYDROXYECTOIN (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) | Unregulated | GMP | Listed in official cosmetic inventory |
| Japan (MHLW) | Unregulated | GMP | Listed in official cosmetic inventory |
| ASEAN (ACD) | Unregulated | GMP | Listed in official cosmetic inventory |
⚠️ 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.
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
pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Optimal Formulation pH Stability Window (0–14)pH 4.5 – 7.5
Outside pH 4.5–7.5, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Maximum Thermal Processing Limit (°C)≤ 70°C
Thermally stable up to 70°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
Academic & Toxicological Synthesis
Tier 2 SynthesisSynthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.
HYDROXYECTOIN (CAS No. 165542-15-4) is a verified cosmetic ingredient primarily functioning as pH Adjuster, Skin Conditioning, Buffering in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 0.1–5.0% within an optimal stability window of pH 4.5–7.5.
Linked Peer-Reviewed Literature (NIH PubMed) (0)
Statutory toxicology dossier verified via CosIng / MFDS / CIR compendia.
Frequently Asked Questions (AEO Position 0)
- Q1. What are the official 7-track regulatory label names for HYDROXYECTOIN?
- Standard label names are US PCPC INCI: 'HYDROXYECTOIN', EU CosIng: 'HYDROXYECTOIN', KR MFDS: 'HYDROXYECTOIN (KR MFDS Registered)', CN NMPA IECIC: 'Unlisted in CN IECIC', and JP JCIA: 'HYDROXYECTOIN'.
- Q2. Is HYDROXYECTOIN restricted or permitted in EU, US, KR, CN, and JP cosmetics?
- Regulatory status summary across 6 jurisdictions — KR: none, EU: none, US: none, CN: none, JP: none, ASEAN: none.
- Q3. What is the typical formulation concentration and optimal pH window for HYDROXYECTOIN?
- Formulate within pH 4.5–7.5 and max process temperature ≤70°C.
- Q4. What are the known formulation incompatibilities and synergy pairings for HYDROXYECTOIN?
- Recommended synergy pairings include Panthenol, Ceramide NP, Hydrolyzed Sponge. Key incompatibilities to avoid: Extreme pH or strong oxidizing agents.