Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 98353060-b0c1-4828-a621-77cbf8669a08
Route
CUTANEOUS
Published
Effective Date 2010-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (2.59 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-01-01
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, ETHYLHEXYL METHOXYCINNAMATE, GLYCERIN, DIPROPYLENE GLYCOL, PEG-10 DIMETHICONE, HEXYL LAURATE, CYCLOTETRASILOXANE,

DIMETHICONE/VINYL DIMETHICONE, CROSSPOLYMER, DISTEARDIMONIUM, HECTORITE, TALC, MAGNESIUM SULFATE, ALUMINUM HYDROXIDE, ALUMINUM STEARATE,

IMIDAZOLIDINYL UREA, METHYLPARABEN, ALOE BARBADENSIS LEAF JUICE, BETULA ALBA BARK EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT,

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, FRAGRANCE, PROPYLPARABEN, BUTYLPARABEN, DIMETHICONE, CAPRYLIC/CAPRIC GLYCERIDES

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, ETHYLHEXYL METHOXYCINNAMATE, GLYCERIN, DIPROPYLENE GLYCOL, PEG-10 DIMETHICONE, HEXYL LAURATE, CYCLOTETRASILOXANE,

DIMETHICONE/VINYL DIMETHICONE, CROSSPOLYMER, DISTEARDIMONIUM, HECTORITE, TALC, MAGNESIUM SULFATE, ALUMINUM HYDROXIDE, ALUMINUM STEARATE,

IMIDAZOLIDINYL UREA, METHYLPARABEN, ALOE BARBADENSIS LEAF JUICE, BETULA ALBA BARK EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT,

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, FRAGRANCE, PROPYLPARABEN, BUTYLPARABEN, DIMETHICONE, CAPRYLIC/CAPRIC GLYCERIDES

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: 2026-02-15T11:55:05.766541 · Updated: 2026-03-14T22:52:25.436081