# TITANIUM DIOXIDE

URL: https://app.greenveil.ai/ingredients/ingredient_cas_13463_67_7
Categories: beauty, cleaning, industrial, pharma
Functions: colorant, uv filter, Binder, Brightener, Deodorizer, Dye, Filler, Masking agent, Opacifer, Pigment, Solid state components, UV stabilizer, aggregate, paint
Identifier: 13463-67-7

> TITANIUM DIOXIDE is used as colorant / uv filter. Greenveil chemical-concern score: 70/100 — High concern based on regulatory listings.. Assessed from 49 sources.

## Safety assessment

- Chemical concern score: 70/100 — High concern based on regulatory listings.
- Confidence: 4
- Rationale: Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm is restricted in cosmetic products under Annex III of the EU Cosmetics Regulation (EC) 1223/2009.

## Regulatory status

- EU: restricted — Annex III of EU Cosmetics Regulation (EC) 1223/2009: substances which cosmetic products must not contain except subject to the restrictions laid down. Product types: (a) face products in loose powder form (b) hair aerosol spray pro­ducts (c) other products Maximum concentration: (a) 25 %; (b) 1,4 % for general consu­mers, and 1.1 % for pro­fessional use. Other conditions: a) (b) Only in the pigmentary form (c) Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation
- EU: allowed_listed — Annex IV of EU Cosmetics Regulation (EC) 1223/2009: colorants allowed in cosmetic products. Conditions of use and warnings: — Purity criteria as set out in Commission Directive 95/45/E (E 171) — Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm, to be used in compliance with Annex III, No 321 (For use as a UV filter, see Annex VI, No 27)
- EU: allowed_listed — Annex VI of EU Cosmetics Regulation (EC) 1223/2009: UV filters allowed in cosmetic products. Maximum concentration: 25%* *: In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g (Maximum concen­tration in ready for use preparation) Other conditions: Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm, to be used in compliance with Annex III, No 321. For the product types under letter (c) of column (f) in Annex III, No 321, the maximum concentration in ready for use preparation provided in column (g) of this entry applies. (For use as a colourant, see Annex IV, No 143)
- US: commercial use observed — EPA CPDat observed this chemical in 41617 composition records across product categories including Construction and building materials, Raw materials, Furniture and furnishings. EPA CPDat classifies this chemical for functional uses including Pigment, Dye, Brightener.
- US: inactive ingredient database — Route: BUCCAL; Dosage form: FILM; Maximum daily exposure: 3 mg
- US: inactive ingredient database — Route: BUCCAL; Dosage form: FILM, SOLUBLE; Maximum daily exposure: 11 mg
- US: inactive ingredient database — Route: BUCCAL; Dosage form: GUM, CHEWING; Maximum daily exposure: 182 mg
- US: inactive ingredient database — Route: DENTAL; Dosage form: PASTE; Potency: 0.5 %w/w
- US: inactive ingredient database — Route: DENTAL; Dosage form: PASTE, DENTIFRICE; Potency: 0.4 %w/w
- US: inactive ingredient database — Route: INTRAUTERINE; Dosage form: SUPPOSITORY, EXTENDED RELEASE; Potency: 1 mg
- US: inactive ingredient database — Route: OPHTHALMIC; Dosage form: INSERT, EXTENDED RELEASE; Potency: 0.4 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE; Maximum daily exposure: 72 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, COATED; Maximum daily exposure: 17 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, COATED PELLETS; Potency: 4.4 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, COATED, EXTENDED RELEASE; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, DELAYED RELEASE; Maximum daily exposure: 55 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, DELAYED RELEASE PELLETS; Maximum daily exposure: 24 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, EXTENDED RELEASE; Maximum daily exposure: 67 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, LIQUID FILLED; Maximum daily exposure: 12 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: DROPS; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: FILM, SOLUBLE; Maximum daily exposure: 2 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: GRANULE, FOR SUSPENSION; Maximum daily exposure: 143 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: POWDER; Potency: 2 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: POWDER, FOR SUSPENSION; Maximum daily exposure: 297 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SUSPENSION; Maximum daily exposure: 113 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET; Maximum daily exposure: 232 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, COATED; Maximum daily exposure: 49 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, DELAYED RELEASE; Maximum daily exposure: 66 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, EXTENDED RELEASE; Maximum daily exposure: 90 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, FILM COATED; Maximum daily exposure: 36 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, FILM COATED, EXTENDED RELEASE; Maximum daily exposure: 11 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, ORALLY DISINTEGRATING; Maximum daily exposure: 6 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE; Maximum daily exposure: 42 mg
- US: inactive ingredient database — Route: RESPIRATORY (INHALATION); Dosage form: CAPSULE; Potency: NA
- US: inactive ingredient database — Route: RESPIRATORY (INHALATION); Dosage form: POWDER; Potency: 2 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: CREAM; Maximum daily exposure: 80 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: GEL; Potency: 0.06 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: LOTION; Potency: NA
- US: inactive ingredient database — Route: TOPICAL; Dosage form: OINTMENT; Potency: 5 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SHAMPOO, SUSPENSION; Potency: 3 %w/v
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SOAP; Potency: 1 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SYSTEM; Maximum daily exposure: 420 mg
- US: inactive ingredient database — Route: TRANSDERMAL; Dosage form: FILM, EXTENDED RELEASE; Potency: NA
- US: inactive ingredient database — Route: VAGINAL; Dosage form: SUPPOSITORY; Potency: NA
- US: marketed drug occurrence — FDA NDC lists this ingredient in 1 active drug products and 1 total products.
- US: marketed drug occurrence — FDA NDC lists this ingredient in 2721 active drug products and 2777 total products.
- US: listed in openFDA substance — openFDA substance registry classifies this ingredient as chemical.

_Assessed by Greenveil._