Vitamin / Coenzyme
HYDROXYPINACOLONE RETINOATE
Skin Conditioning
Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR
What is HYDROXYPINACOLONE RETINOATE (CAS N/A) in cosmetics and what are its global regulatory limits?
HYDROXYPINACOLONE RETINOATE (CAS No. N/A) is a verified cosmetic ingredient primarily functioning as Skin Conditioning 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) | HYDROXYPINACOLONE RETINOATE (KR MFDS Registered) | |
| 2. Korea Former Nomenclature History | — | — |
| 3. European Union (EU CosIng Glossary) | HYDROXYPINACOLONE RETINOATE | |
| 4. United States (US PCPC / MoCRA INCI) | HYDROXYPINACOLONE RETINOATE | |
| 5. US FDA OTC Monograph Active Name | — (Cosmetic Inactive / Non-OTC) | — |
| 6. China (NMPA IECIC Standard Name) | 羟基频哪酮视黄酸酯 | |
| 7. Japan (JCIA Standard / MHLW Quasi-Drug) | HYDROXYPINACOLONE RETINOATE (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 #5269 |
| 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 |
|---|---|---|---|
| CN IECIC Historical Max Use | leave_on | ≤ 0.5% | Safe (MoS≥100)NMPA IECIC (2025) Entry 05390 (2025) |
| CN IECIC Historical Max Use | rinse_off | ≤ 0.2% | Safe (MoS≥100)NMPA IECIC (2025) Entry 05390 (2025) |
⚠️ 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. Intracellular Conversion→ Upregulation / Activation
Nuclear RAR / RXR Receptor Binding
→Upregulated Type I/III Procollagen Synthesis
2. Photoaging Enzyme Blockade⊣ Inhibition / Blockade
AP-1 & Matrix Metalloproteinases (MMP-1/9)
⊣Inhibition of Dermal Collagen Degradation
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: HYDROXYPINACOLONE RETINOATE | CAS No.: N/A | EC No.: N/A
- Origin: VITAMIN | Functions: Skin Conditioning
- Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS
- Official Regional Label Names: US [HYDROXYPINACOLONE RETINOATE] · EU [HYDROXYPINACOLONE RETINOATE] · CN [羟基频哪酮视黄酸酯] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
- Ester of all-trans retinoic acid that binds directly to retinoid nuclear receptors (RAR) without requiring metabolic conversion. Stimulates cellular turnover and extracellular matrix gene expression with a markedly lower irritation and erythema profile than traditional retinol.
■ [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. 5269 (羟基频哪酮视黄酸酯))
- 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): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 0.5% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 0.2%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
- Dosage engineered according to primary function and phase solubility.
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
- Addition Phase: Standard Phase
- Optimal pH Range: pH 4.5 ~ 7.5 | Max Process Temp: | Electrolyte Tolerance: MEDIUM
- Incompatibility / Caution: Perform preliminary compatibility testing when combining with strong electrolytes or extreme pH actives
- Synergy Pairings: GLYCERIN, PANTHENOL, TOCOPHEROL | Reference Trade Names: HYDROXYPINACOLONE RETINOATE
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
- Validated against official regulatory compendia (MFDS/CosIng/CIR/SCCS) and physicochemical standards.
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 HYDROXYPINACOLONE RETINOATE?
- Standard label names are US PCPC INCI: 'HYDROXYPINACOLONE RETINOATE', EU CosIng: 'HYDROXYPINACOLONE RETINOATE', KR MFDS: 'HYDROXYPINACOLONE RETINOATE (KR MFDS Registered)', CN NMPA IECIC: '羟基频哪酮视黄酸酯', and JP JCIA: 'HYDROXYPINACOLONE RETINOATE'.
- Q2. Is HYDROXYPINACOLONE RETINOATE 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 HYDROXYPINACOLONE RETINOATE?
- Formulate within pH 4.5–7.5 and max process temperature ≤70°C.
- Q4. What are the known formulation incompatibilities and synergy pairings for HYDROXYPINACOLONE RETINOATE?
- Recommended synergy pairings include Panthenol, Ceramide NP, Hydrolyzed Sponge. Key incompatibilities to avoid: Extreme pH or strong oxidizing agents.