What are the official 7-track regulatory label names for CANDELILLA CERA?

Standard label names are US PCPC INCI: 'CANDELILLA CERA', EU CosIng: 'CANDELILLA CERA', KR MFDS: 'CANDELILLA CERA (KR MFDS Registered)', CN NMPA IECIC: '小烛树(EUPHORBIA CERIFERA)蜡', and JP JCIA: 'CANDELILLA CERA'.

Is CANDELILLA CERA 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.

What is the typical formulation concentration and optimal pH window for CANDELILLA CERA?

In sun_color systems, CANDELILLA CERA is typically formulated between 2% and 10% (median 2.8%), with an optimal stability window of pH 4–8.

What are the known formulation incompatibilities and synergy pairings for CANDELILLA CERA?

Recommended synergy pairings include GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL. Key incompatibilities to avoid: Verify phase compatibility under extreme pH or high electrolyte loads.

Plant / Botanical

CANDELILLA CERA

Film FormingEmollient

[EU CosIng Official Definition] Candelilla Cera is the extract of the wax obtained from the candelilla, Euphorbia cerifera, Euphorbiaceae

Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR

What is CANDELILLA CERA (CAS 8006-44-8) in cosmetics and what are its global regulatory limits?

CANDELILLA CERA (CAS No. 8006-44-8) is a verified cosmetic ingredient primarily functioning as Film Forming, Emollient in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 2–10% within an optimal stability window of pH 4–8.

7-Track Official Regulatory Label Names Matrix

Primary Statutory Gazette Only · Zero Machine Translation

7-Track Official Statutory Label Names for CANDELILLA CERA
Jurisdiction Track	Official Statutory Label Name	One-Click Copy
1. Korea (MFDS Standard Name)	CANDELILLA CERA (KR MFDS Registered)
2. Korea Former Nomenclature History	—	—
3. European Union (EU CosIng Glossary)	CANDELILLA CERA
4. United States (US PCPC / MoCRA INCI)	CANDELILLA CERA
5. US FDA OTC Monograph Active Name	— (Cosmetic Inactive / Non-OTC)	—
6. China (NMPA IECIC Standard Name)	小烛树(EUPHORBIA CERIFERA)蜡
7. Japan (JCIA Standard / MHLW Quasi-Drug)	CANDELILLA CERA (Standard INCI Reference)

Layer 1 — Statutory Regulatory Limits Across 6 Regions

Layer 1 Statutory Regulatory Limits Across 6 Regions for CANDELILLA CERA
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 #7144
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.

Interactive Quartile Box-Plot (Min–Q1–Median–Q3–Max)

Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit

Sunscreen / Colorn=6

Min 2% · Q1 2.525% · Median 2.8% · Q3 8.25% · Max 10%

Sunscreen / Color — Sun care & color cosmetics dispersion / sensory modifier

Verified Source: Global Starter Formulation Library Statistical Distribution (n=6, EVONIK 6) (cir_safety) · EVONIK 6

Typical Median: 2.8%

Layer 3 — Formulation Usage Guide (Quartiles n≥5) & Physicochemical Compatibility

Layer 3 Formulation Concentration Quartiles by Product Category for CANDELILLA CERA
Formulation Group	Min – Q1 – Median – Q3 – Max (%)	Role & Mechanism	Source ID
Group D — Sunscreen (UV) / Color Cosmetics / Foundation	2% · 2.525% · 2.8% · 8.25% · 10%	Sun care & color cosmetics dispersion / sensory modifier	Global Starter Formulation Library Statistical Distribution (n=6, EVONIK 6)

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

Water or glycol phase soluble/dispersible

Optimal Formulation pH Stability Window (0–14)pH 4.0 – 8.0

Outside pH 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.

Maximum Thermal Processing Limit (°C)≤ 50°C

Thermally stable up to 50°C during standard emulsification.

HLB Scale (0–20) & Colloidal Micelle / Lamellar Phase Simulator

O/W Oil-in-Water Micelle Emulsion (Lotion / Cream)

Simulate HLB: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.

+ GLYCERIN + CAPRYLIC/CAPRIC TRIGLYCERIDE + TOCOPHEROL

Nominative Trade Name References (Trademark Act Art. 90(1)(2))

CANDELILLA CERA

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 Synthesis

Synthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.

■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: CANDELILLA CERA | CAS No.: 8006-44-8 | EC No.: 232-347-0 - Origin: PLANT | Functions: , - Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS - Official Regional Label Names: US [CANDELILLA CERA] · EU [CANDELILLA CERA] · CN [小烛树(EUPHORBIA CERIFERA)蜡] · JP [-] · JP Quasi-Drug [-] ■ [2. Dermatological Mechanism of Action & Functional Role] - Candelilla Cera is the extract of the wax obtained from the candelilla, Euphorbia cerifera, Euphorbiaceae Classified under origin 'plant', 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. 7144 (小烛树(EUPHORBIA CERIFERA)蜡)) - 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): Quantum satis (QS) within standard cosmetic safety margins ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [sun_color] Typical range: 2.0 ~ 10.0% (Median 2.8%, Ref: Global Starter Formulation Library Statistical Distribution (n=6, EVONIK 6)) — Sun care & color cosmetics dispersion / sensory modifier ■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)] - Addition Phase: Water Phase or Cool-down Phase (< 45°C) - Optimal pH Range: pH 4.0 ~ 8.0 | Max Process Temp: Max 50°C | Electrolyte Tolerance: MEDIUM - Incompatibility / Caution: Verify phase compatibility under extreme pH or high electrolyte loads - Synergy Pairings: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL | Reference Trade Names: CANDELILLA CERA ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 36582047 (2023, Contact Dermatitis): Severe contact cheilitis from cera alba and other cosmetic oils, fats and waxes in lip balms - PMID 31400015 (2020, Contact Dermatitis): A peculiar case of sensitization to Candelilla Cera and sucrose (di)stearate in a toddler

Linked Peer-Reviewed Literature (NIH PubMed) (2)

Severe contact cheilitis from cera alba and other cosmetic oils, fats and waxes in lip balms [PMID: 36582047 · 2023]

Aerts O, Pyl J, Mangodt E, Dendooven E · Contact Dermatitis (2023)

A peculiar case of sensitization to Candelilla Cera and sucrose (di)stearate in a toddler [PMID: 31400015 · 2020]

Darrigade AS, Dendooven E, Mangodt E, Vermander E, Hagendorens M, Aerts O · Contact Dermatitis (2020)

Frequently Asked Questions (AEO Position 0)

Q1. What are the official 7-track regulatory label names for CANDELILLA CERA?: Standard label names are US PCPC INCI: 'CANDELILLA CERA', EU CosIng: 'CANDELILLA CERA', KR MFDS: 'CANDELILLA CERA (KR MFDS Registered)', CN NMPA IECIC: '小烛树(EUPHORBIA CERIFERA)蜡', and JP JCIA: 'CANDELILLA CERA'.
Q2. Is CANDELILLA CERA 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 CANDELILLA CERA?: In sun_color systems, CANDELILLA CERA is typically formulated between 2% and 10% (median 2.8%), with an optimal stability window of pH 4–8.
Q4. What are the known formulation incompatibilities and synergy pairings for CANDELILLA CERA?: Recommended synergy pairings include GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL. Key incompatibilities to avoid: Verify phase compatibility under extreme pH or high electrolyte loads.