Ingredient Dictionary/zinc-gluconate/ZINC GLUCONATE
Tier 1 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
Synthetic

ZINC GLUCONATE

AntimicrobialDeodorantSkin ConditioningOral Care
[EU CosIng Official Definition] Zinc Gluconate is the zinc salt of gluconic acid that conforms to the formula:
Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR

What is ZINC GLUCONATE (CAS 4468-02-4) in cosmetics and what are its global regulatory limits?

ZINC GLUCONATE (CAS No. 4468-02-4) is a verified cosmetic ingredient primarily functioning as Antimicrobial, Deodorant, Skin Conditioning in topical formulations. Regulated under KR MFDS (Restricted) and EU 1223/2009 CosIng (Restricted) statutory frameworks, it is typically formulated at 1–1% 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 ZINC GLUCONATE
Jurisdiction TrackOfficial Statutory Label NameOne-Click Copy
1. Korea (MFDS Standard Name)ZINC GLUCONATE (KR MFDS Registered)
2. Korea Former Nomenclature History——
3. European Union (EU CosIng Glossary)ZINC GLUCONATE
4. United States (US PCPC / MoCRA INCI)ZINC GLUCONATE
5. US FDA OTC Monograph Active Name— (Cosmetic Inactive / Non-OTC)—
6. China (NMPA IECIC Standard Name)葡糖酸锌
7. Japan (JCIA Standard / MHLW Quasi-Drug)ZINC GLUCONATE (Standard INCI Reference)

Layer 1 — Statutory Regulatory Limits Across 6 Regions

Layer 1 Statutory Regulatory Limits Across 6 Regions for ZINC GLUCONATE
RegionStatusMax LimitConditions & Statutory Source
Korea (MFDS)RestrictedGMPListed in official cosmetic inventory
Europe (EU)RestrictedGMPListed in official cosmetic inventory
United States (FDA)UnregulatedGMPListed in official cosmetic inventory
China (NMPA)Listed / AllowedGMPIECIC Entry #5125
Japan (MHLW)UnregulatedGMPListed in official cosmetic inventory
ASEAN (ACD)UnregulatedGMPListed 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

Aqueous Serum / Ampoulen=6
Min 1% · Q1 1% · Median 1% · Q3 1% · Max 1%
Aqueous Serum / Ampoule — Aqueous serum, toner & hydrogel matrix formulation component
Verified Source: Global Starter Formulation Library Statistical Distribution (n=6, SEPPIC 6) (cir_safety) · SEPPIC 6
Typical Median: 1%

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

Layer 3 Formulation Concentration Quartiles by Product Category for ZINC GLUCONATE
Formulation GroupMin – Q1 – Median – Q3 – Max (%)Role & MechanismSource ID
Group A — Aqueous Toner / Serum / Ampoule1% · 1% · 1% · 1% · 1%Aqueous serum, toner & hydrogel matrix formulation componentGlobal Starter Formulation Library Statistical Distribution (n=6, SEPPIC 6)
Cutaneous Permeation Science (500 Dalton Rule)MW: Macro/Complex · LogP: N/A

Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery

Stratum Corneum (Brick & Mortar Barrier · 10–20 µm)500 Da Molecular Weight Cutoff BarrierViable Epidermis (Keratinocytes & Melanocytes · 50–100 µm)Target for Brightening (Tyrosinase/Melanosome) & Barrier LipidsPapillary Dermis (Fibroblasts & ECM Collagen · 150–300 µm)Target for Collagen I/III Synthesis, Peptides, PDRN & ExosomesEpidermal Passive Permeation (<500 Da)
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
0245.5791114

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

Maximum Thermal Processing Limit (°C)≤ 50°C
25°C45°C60°C75°C85°C100°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)
HLB 11.5
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)O/W Droplet
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)

+ GLYCERIN+ CAPRYLIC/CAPRIC TR…+ TOCOPHEROL✕ Verify phase compati…ZINC GLUCONATE
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))
ZINC GLUCONATE

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: ZINC GLUCONATE | CAS No.: 4468-02-4 | EC No.: 224-736-9 - Origin: SYNTHETIC | Functions: , , , - Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS - Official Regional Label Names: US [ZINC GLUCONATE] · EU [ZINC GLUCONATE] · CN [葡糖酸锌] · JP [-] · JP Quasi-Drug [-] ■ [2. Dermatological Mechanism of Action & Functional Role] - Zinc Gluconate is the zinc salt of gluconic acid that conforms to the formula: Classified under origin 'synthetic', 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: RESTRICTED | EU: RESTRICTED | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 5125 (葡糖酸锌)) - [KR / COMPOSITION / limited] (Max 1%): - [EU / COMPOSITION / limited] (Max 1%): - 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)] - [aqueous_serum] Typical range: 1.0 ~ 1.0% (Median 1.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=6, SEPPIC 6)) — Aqueous serum, toner & hydrogel matrix formulation component ■ [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: ZINC GLUCONATE ■ [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 ZINC GLUCONATE?
Standard label names are US PCPC INCI: 'ZINC GLUCONATE', EU CosIng: 'ZINC GLUCONATE', KR MFDS: 'ZINC GLUCONATE (KR MFDS Registered)', CN NMPA IECIC: '葡糖酸锌', and JP JCIA: 'ZINC GLUCONATE'.
Q2. Is ZINC GLUCONATE restricted or permitted in EU, US, KR, CN, and JP cosmetics?
Regulatory status summary across 6 jurisdictions — KR: restricted, EU: restricted, US: none, CN: allowed, JP: none, ASEAN: none.
Q3. What is the typical formulation concentration and optimal pH window for ZINC GLUCONATE?
In aqueous_serum systems, ZINC GLUCONATE is typically formulated between 1% and 1% (median 1%), with an optimal stability window of pH 4–8.
Q4. What are the known formulation incompatibilities and synergy pairings for ZINC GLUCONATE?
Recommended synergy pairings include GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL. Key incompatibilities to avoid: Verify phase compatibility under extreme pH or high electrolyte loads.