Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 03382d4f-0241-43c6-b6b6-b6c6ccd05b50
Route
CUTANEOUS
Published
Effective Date 2010-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (4.48 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2008-07-01
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:



WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, CYCLOHEXASILOXANE, GLYCERIN, ALCOHOL DENAT., DIMETHICONE, TALC, NEOPENTYL GLYCOL DIETHYLHEXANOATE,

PEG-10 DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SODIUM CHLORIDE, SORBITAN SESQUIOLEATE, METHYLPARABEN, PEG-7 DIMETHICONE, FRAGRANCE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, IRON OXIDES(CI 77491), IRON OXIDES(CI 77492), STEARIC ACID, IRON OXIDES(CI 77499), PROPYLPARABEN, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, PORTULACA OLERACEA EXTRACT, OENOTHERA BIENNIS (EVENING PRIMROSE) FLOWER EXTRACT, ALOE FEROX LEAF EXTRACT



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:



WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, CYCLOHEXASILOXANE, GLYCERIN, ALCOHOL DENAT., DIMETHICONE, TALC, NEOPENTYL GLYCOL DIETHYLHEXANOATE,

PEG-10 DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SODIUM CHLORIDE, SORBITAN SESQUIOLEATE, METHYLPARABEN, PEG-7 DIMETHICONE, FRAGRANCE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, IRON OXIDES(CI 77491), IRON OXIDES(CI 77492), STEARIC ACID, IRON OXIDES(CI 77499), PROPYLPARABEN, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, PORTULACA OLERACEA EXTRACT, OENOTHERA BIENNIS (EVENING PRIMROSE) FLOWER EXTRACT, ALOE FEROX LEAF EXTRACT



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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:05.770849 · Updated: 2026-03-14T22:52:25.436081