# ZINC OXIDE (zinc-oxide) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/zinc-oxide
- **Standard INCI**: `ZINC OXIDE`
- **KR MFDS Standard Name**: `징크옥사이드`
- **CAS No.**: `1314-13-2`
- **EC / EINECS No.**: `215-222-5`
- **Origin**: `mineral`
- **Functions**: 항균제, 증량제, 색소, 구강관리제, 피부보호제, 광안정제, 자외선차단제
- **Molecular Formula / MW**: `ZnO` (81.38 g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 징크옥사이드 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | ZINC OXIDE |
| US (PCPC / MoCRA INCI) | ZINC OXIDE |
| US (FDA OTC Monograph) | ZINC OXIDE |
| CN (NMPA IECIC) | 氧化锌 |
| JP (JCIA / MHLW QD) | 酸化亜鉛 (QD: 酸化亜鉛) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `restricted`
- **EU (1223/2009)**: `restricted`
- **US (FDA/MoCRA)**: `restricted`
- **CN (NMPA IECIC)**: `restricted` (Entry: `7475`)
- **JP (MHLW)**: `noted`
- **ASEAN (ACD)**: `restricted`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- Listed within general cosmetic GMP safety thresholds.

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 6.5 – 8.2
- **Max Process Temp**: ≤ 85°C
- **Synergy Pairings**: TITANIUM DIOXIDE, POLYHYDROXYSTEARIC Acid, TRIETHOXYCAPRYLYLSILANE, DISTEARDIMONIUM HECTORITE, BUTYLOCTYL SALICYLATE
- **Incompatibilities**: CRITICAL FORMULATION HAZARD: Below pH 6.5, ZnO dissolves into Zn2+ ions, causing upward pH drift (>8.0), severe agglomeration, whitening, and immediate cross-linking/collapse of acrylic polymers (Carbomer)! Always use hydrophobic surface-coated grades (Triethoxycaprylylsilane) + Polyhydroxystearic Acid dispersant and maintain pH 7.0~8.0 or formulate as W/O

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: ZINC OXIDE | CAS No.: 1314-13-2 | EC No.: 215-222-5
  - Origin: MINERAL | Functions: , , , , , , 
  - Physicochemical Profile: Formula ZnO | MW 81.38 g/mol | /   | Ionic Nature: amphoteric | PubChem CID 14806
  - Official Regional Label Names: US [ZINC OXIDE] · EU [ZINC OXIDE] · CN [氧化锌] · JP [酸化亜鉛] · JP Quasi-Drug [酸化亜鉛]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Zinc Oxide is the inorganic oxide.
To identify the colourant meeting the requirements for labelling purposes in the EU, the INCI Name CI 77947 must be used.  
It conforms generally to the formula: Classified under origin 'mineral', 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: RESTRICTED | CN: RESTRICTED | JP: NOTED | ASEAN: RESTRICTED (CN IECIC (2025) Entry No. 7475 (氧化锌))
  - [KR / COMPOSITION / limited] (Max 25%): 
  - [JP / COMPOSITION / noted]: 
  - [US / COMPOSITION / noted]: 
  - 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: 3.0 ~ 25.0% (Median 15.0%, Ref: US FDA OTC Monograph M020, EU Annex VI #30 & KR MFDS Annex 2) — Broad-spectrum mineral UV filter & skin protectant (Global max 25.0%, US FDA GRASE Category I)
  - [emulsion_cream] Typical range: 10.0 ~ 20.0% (Median 10.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=5, EVONIK 4 · ELEMENTIS 1)) — Emulsion cream & lotion structural / conditioning agent
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Oil / Dispersion Phase (High-shear homogenization with Polyhydroxystearic Acid and Disteardimonium Hectorite)
  - Optimal pH Range: pH 6.5 ~ 8.2 | Max Process Temp: Max 85°C | Electrolyte Tolerance: NONE
  - Incompatibility / Caution: CRITICAL FORMULATION HAZARD: Below pH 6.5, ZnO dissolves into Zn2+ ions, causing upward pH drift (>8.0), severe agglomeration, whitening, and immediate cross-linking/collapse of acrylic polymers (Carbomer)! Always use hydrophobic surface-coated grades (Triethoxycaprylylsilane) + Polyhydroxystearic Acid dispersant and maintain pH 7.0~8.0 or formulate as W/O
  - Synergy Pairings: TITANIUM DIOXIDE, POLYHYDROXYSTEARIC Acid, TRIETHOXYCAPRYLYLSILANE, DISTEARDIMONIUM HECTORITE, BUTYLOCTYL SALICYLATE | Reference Trade Names: Z-COTE® HP1 (BASF), Microno® Zinc
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 30444533 (2019, Photodermatol Photoimmunol Photomed): A review of inorganic UV filters zinc oxide and titanium dioxide
  - PMID 28509652 (2017, J Toxicol Environ Health B Crit Rev): Risk assessment of zinc oxide, a cosmetic ingredient used as a UV filter of sunscreens
  - PMID 20795900 (2010, Nanotoxicology): Zinc oxide nanoparticles in modern sunscreens: an analysis of potential exposure and hazard

## 6. Linked PubMed Literature
- [PMID: 30444533] A review of inorganic UV filters zinc oxide and titanium dioxide — *Photodermatol Photoimmunol Photomed* (2019)
- [PMID: 28509652] Risk assessment of zinc oxide, a cosmetic ingredient used as a UV filter of sunscreens — *J Toxicol Environ Health B Crit Rev* (2017)
- [PMID: 20795900] Zinc oxide nanoparticles in modern sunscreens: an analysis of potential exposure and hazard — *Nanotoxicology* (2010)
- [PMID: 22591031] In vitro testing of zinc oxide sunscreens — *Int J Cosmet Sci* (2012)
- [PMID: 24198489] Titanium dioxide and zinc oxide nanoparticles in sunscreens: focus on their safety and effectiveness — *Nanotechnol Sci Appl* (2011)
- [PMID: 42315566] Successive nitric oxide and lipoic acid priming mitigates ZnONPs toxicity in wheat: experimental and DFT insights — *Sci Rep* (2026)
- [PMID: 42310896] Enhancing Photoprotection: Assessing Visible Light Photoprotection in Tinted Inorganic Sunscreens — *Photodermatol Photoimmunol Photomed* (2026)
- [PMID: 42304407] Green-synthesized quantum dots from quercus brantii for infected polymicrobial wound healing: mechanisms and biocompatibility — *BMC Biotechnol* (2026)
- [PMID: 42297993] Polyacrylamide hybridized double networks with polysaccharides and zinc oxide nanoparticles as a Novel approach for removing animal glue stain from paper manuscripts — *Sci Rep* (2026)
- [PMID: 42297939] Biosynthesis of ecofriendly antibacterial nanoparticles with healing effects in a murine diabetic skin infection model — *Sci Rep* (2026)
- [PMID: 42295518] Effect of zinc oxide nanoparticle supplementation in Santa Inês ewes during the transition period — *Trop Anim Health Prod* (2026)
- [PMID: 42292040] ZnO Nanocrystals Inhibit Escherichia coli Biofilms by Suppressing glgA- and gltB-Dependent EPS Biosynthesis — *Int J Nanomedicine* (2026)
- [PMID: 42286977] Lead Borate Glass Series for Radiation Shielding Applications: The Influence of CaO, BaO and ZnO on Optical, Mechanical, and Radiation Shielding Properties — *Luminescence* (2026)
- [PMID: 42273339] Electrospun Poly(caprolactone)/Poly(ethylene oxide) Membranes Incorporating Green-Synthesized Zinc Oxide Nanoparticles for Enhanced Wound Healing Applications — *Small Sci* (2026)
- [PMID: 42270820] Biosynthesis of antibacterial zinc oxide nanoparticles from endophytic Streptomyces werraensis — *Sci Rep* (2026)
- [PMID: 42255438] Zinc oxide nanoparticles mitigate insulin resistance in a D-galactose-induced C57BL/6 mouse model — *Front Endocrinol (Lausanne)* (2026)
- [PMID: 42316333] Swiss Practice Recommendations for Chronic Prurigo Including Prurigo Nodularis — *Int J Dermatol* (2026)