# TITANIUM DIOXIDE (titanium-dioxide) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/titanium-dioxide
- **Standard INCI**: `TITANIUM DIOXIDE`
- **KR MFDS Standard Name**: `티타늄디옥사이드`
- **CAS No.**: `13463-67-7`
- **EC / EINECS No.**: `236-675-5`
- **Origin**: `mineral`
- **Functions**: 색소, 불투명화제, 자외선차단제
- **Molecular Formula / MW**: `TiO2` (79.87 g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 티타늄디옥사이드 |
| KR (Former Names) | 티타늄다이옥사이드 |
| EU (CosIng 1223/2009) | TITANIUM DIOXIDE |
| US (PCPC / MoCRA INCI) | TITANIUM DIOXIDE |
| US (FDA OTC Monograph) | TITANIUM DIOXIDE |
| CN (NMPA IECIC) | 二氧化钛 |
| JP (JCIA / MHLW QD) | 酸化チタン (QD: 酸化チタン) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `restricted`
- **EU (1223/2009)**: `restricted`
- **US (FDA/MoCRA)**: `restricted`
- **CN (NMPA IECIC)**: `restricted` (Entry: `2210`)
- **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**: 4.5 – 9
- **Max Process Temp**: ≤ 90°C
- **Synergy Pairings**: ZINC OXIDE, ALUMINA, TRIETHOXYCAPRYLYLSILANE, POLYHYDROXYSTEARIC ACID, C15-19 ALKANE
- **Incompatibilities**: Uncoated TiO2 exhibits photocatalytic free-radical generation under UV light; must use Alumina/Silica/Dimethicone surface-coated grades and high-shear dispersants to prevent agglomeration and SPF loss

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: TITANIUM DIOXIDE | CAS No.: 13463-67-7 | EC No.: 236-675-5
  - Origin: MINERAL | Functions: , , 
  - Physicochemical Profile: Formula TiO2 | MW 79.87 g/mol | /   | Ionic Nature: non-ionic | PubChem CID 26042
  - Official Regional Label Names: US [TITANIUM DIOXIDE] · EU [TITANIUM DIOXIDE] · CN [二氧化钛] · JP [酸化チタン] · JP Quasi-Drug [酸化チタン]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Titanium Dioxide is the inorganic oxide.
To identify the colourant meeting the requirements for labelling purposes in the EU, the INCI Name 77891 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. 2210 (二氧化钛))
  - [KR / COMPOSITION / limited] (Max 25%): 
  - [JP / COMPOSITION / noted]: 
  - [US / COMPOSITION / noted]: 
  - [EU / COMPOSITION / limited] (Max 1.4%): 
  - 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: 1.0 ~ 25.0% (Median 8.0%, Ref: US FDA OTC Monograph M020, EU Annex IV/VI & KR MFDS Annex 2) — Mineral UVB/UVA2 sunscreen filter & white pigment (CI 77891, Global max 25.0%)
  - [emulsion_cream] Typical range: 0.4 ~ 25.0% (Median 1.25%, Ref: Global Starter Formulation Library Statistical Distribution (n=15, EVONIK 7 · SEPPIC 6 · ELEMENTIS 2)) — Emulsion cream & lotion structural / conditioning agent
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Oil or Water Dispersion Phase (High-shear milling/homogenization with wetting dispersants)
  - Optimal pH Range: pH 4.5 ~ 9.0 | Max Process Temp: Max 90°C | Electrolyte Tolerance: HIGH
  - Incompatibility / Caution: Uncoated TiO2 exhibits photocatalytic free-radical generation under UV light; must use Alumina/Silica/Dimethicone surface-coated grades and high-shear dispersants to prevent agglomeration and SPF loss
  - Synergy Pairings: ZINC OXIDE, ALUMINA, TRIETHOXYCAPRYLYLSILANE, POLYHYDROXYSTEARIC ACID, C15-19 ALKANE | Reference Trade Names: PARSOL® TX (DSM), Eusolex® T-2000, T-Lite™ SF
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 42310896 (2026, Photodermatol Photoimmunol Photomed): Enhancing Photoprotection: Assessing Visible Light Photoprotection in Tinted Inorganic Sunscreens
  - PMID 42300198 (2026, J Mater Chem B): Localised Al(OH)(3) quantum dot passivation for safe-by-design rutile TiO(2) nanomaterials for UV protection
  - PMID 42260063 (2026, Am J Clin Dermatol): What's New in Photoprotection?

## 6. Linked PubMed Literature
- [PMID: 42310896] Enhancing Photoprotection: Assessing Visible Light Photoprotection in Tinted Inorganic Sunscreens — *Photodermatol Photoimmunol Photomed* (2026)
- [PMID: 42300198] Localised Al(OH)(3) quantum dot passivation for safe-by-design rutile TiO(2) nanomaterials for UV protection — *J Mater Chem B* (2026)
- [PMID: 42260063] What's New in Photoprotection? — *Am J Clin Dermatol* (2026)
- [PMID: 42252931] Emerging trends of nanotechnology-based drug delivery for wound healing — *J Drug Target* (2026)
- [PMID: 42246454] Encapsulating TiO(2) Nanoparticles in Chitosan-Based Porous Microspheres as Multifunctional UV Filters — *Langmuir* (2026)
- [PMID: 42168491] Examining the immunomodulatory role of nanoparticles on mast cell activation — *Sci Rep* (2026)
- [PMID: 42117953] TiO(2) Nanocomposite GelMA Film as Wound Dressing: Physicochemical, Structural, Mechanical Properties and Antibacterial Activity Against Staphylococcus aureus — *Nanomaterials (Basel)* (2026)
- [PMID: 42084842] Natural photoprotection under scrutiny: an in vitro evaluation — *Photochem Photobiol Sci* (2026)
- [PMID: 42067042] Pending Food and Drug Administration approval of bemotrizinol: A potential turning point for United States sunscreen formulation — *J Am Acad Dermatol* (2026)
- [PMID: 42029092] 3D-Printed lesion-conformal light-guiding patches for precise and personalized psoriasis phototherapy — *Biomater Sci* (2026)
- [PMID: 42251220] Significance of oscillatory TiO(2)-water nanofluid and heat transfer performance over vertical magnetized flat plate using artificial neural network — *Discov Nano* (2026)
- [PMID: 42113082] Numerical investigation of MHD flow and heat transfer of hybrid nanofluid over a Darcy-Forchheimer shrinking sheet using the Reiner-Philippoff model with significant viscous dissipation and Joule heating effects — *Discov Nano* (2026)