Synthetic
CETYL PALMITATE
FragranceSkin ConditioningEmollient
Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR
What is CETYL PALMITATE (CAS 540-10-3) in cosmetics and what are its global regulatory limits?
CETYL PALMITATE (CAS No. 540-10-3) is a verified cosmetic ingredient primarily functioning as Fragrance, Skin Conditioning, Emollient 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) | CETYL PALMITATE (KR MFDS Registered) | |
| 2. Korea Former Nomenclature History | — | — |
| 3. European Union (EU CosIng Glossary) | CETYL PALMITATE | |
| 4. United States (US PCPC / MoCRA INCI) | CETYL PALMITATE | |
| 5. US FDA OTC Monograph Active Name | — (Cosmetic Inactive / Non-OTC) | — |
| 6. China (NMPA IECIC Standard Name) | 鲸蜡醇棕榈酸酯 | |
| 7. Japan (JCIA Standard / MHLW Quasi-Drug) | CETYL PALMITATE (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 #3567 |
| 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.
CETYL PALMITATE (CAS No. 540-10-3) is a verified cosmetic ingredient primarily functioning as Fragrance, Skin Conditioning, Emollient 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 CETYL PALMITATE?
- Standard label names are US PCPC INCI: 'CETYL PALMITATE', EU CosIng: 'CETYL PALMITATE', KR MFDS: 'CETYL PALMITATE (KR MFDS Registered)', CN NMPA IECIC: '鲸蜡醇棕榈酸酯', and JP JCIA: 'CETYL PALMITATE'.
- Q2. Is CETYL PALMITATE 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 CETYL PALMITATE?
- Formulate within pH 4.5–7.5 and max process temperature ≤70°C.
- Q4. What are the known formulation incompatibilities and synergy pairings for CETYL PALMITATE?
- Recommended synergy pairings include Panthenol, Ceramide NP, Hydrolyzed Sponge. Key incompatibilities to avoid: Extreme pH or strong oxidizing agents.