Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 269986f7-4a7d-4cbb-8a8b-8502012fcbf0
Route
CUTANEOUS
Published
Effective Date 2010-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (1.68 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-06-01
Description

Active Ingredient: TITANIUM DIOXIDE

Medication Information

Description

Warnings:

When using this product

    Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

    Rash or irritation develops and lasts.





Directions:

    Apply evenly before sun exposure and as needed.

    Children under 6months of age; ask a doctor.



Section 51727-6

Inactive Ingredients:

MICA, TALC, SILICA, NYLON-12, DIISOSTEARYL MALATE, PENTAERYTHRITYL TETRAISOSTEARATE, HYDROGENATED POLY(C6-14 OLEFIN), ETHYLHEXYL METHOXYCINNAMATE,

IRON OXIDES(CI77492), METHICONE, DIMETHICONE, CAPRYLIC/CAPRIC TRIGLYCERIDE, IRON OXIDES(CI77491), HYDROGENATED LECITHIN, DEA-C8-18 PERFLUOROALKYLETHYL PHOSPHATE, METHYLPARABEN, FRAGRANCE, IRON OXIDES(CI77499), PROPYLPARABEN, HEXYL CINNAMAL, MONTMORILLONITE, ALUMINUM STARCH OCTENYLSUCCINATE,

HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, BUTYLPHENYL METHYLPROPIONAL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, HYDROXYCITRONELLAL



Section 51945-4

Section 55106-9

Active Ingredient: TITANIUM DIOXIDE

Structured Label Content

Description (34089-3)

Warnings:

When using this product

    Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

    Rash or irritation develops and lasts.





Directions:

    Apply evenly before sun exposure and as needed.

    Children under 6months of age; ask a doctor.



Section 51727-6 (51727-6)

Inactive Ingredients:

MICA, TALC, SILICA, NYLON-12, DIISOSTEARYL MALATE, PENTAERYTHRITYL TETRAISOSTEARATE, HYDROGENATED POLY(C6-14 OLEFIN), ETHYLHEXYL METHOXYCINNAMATE,

IRON OXIDES(CI77492), METHICONE, DIMETHICONE, CAPRYLIC/CAPRIC TRIGLYCERIDE, IRON OXIDES(CI77491), HYDROGENATED LECITHIN, DEA-C8-18 PERFLUOROALKYLETHYL PHOSPHATE, METHYLPARABEN, FRAGRANCE, IRON OXIDES(CI77499), PROPYLPARABEN, HEXYL CINNAMAL, MONTMORILLONITE, ALUMINUM STARCH OCTENYLSUCCINATE,

HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, BUTYLPHENYL METHYLPROPIONAL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, HYDROXYCITRONELLAL



Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active Ingredient: TITANIUM DIOXIDE

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:08.556193 · Updated: 2026-03-14T22:52:29.225907