Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID aff0f6e9-6d9f-4b78-a33b-ff8aa4cf0f79
Route
CUTANEOUS
Published
Effective Date 2010-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (1.23 mL) Zinc Cation (0.93 mL)

Identifiers & Packaging

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

Description

Active Ingredients: TITANIUM DIOXIDE, ZINC OXIDE


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, GLYCERIN, ETHYLHEXYL METHOXYCINNAMATE, PEG-10 DIMETHICONE, HEXYL LAURATE, TALC, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, DIMETHICONE, ULTRAMARINES, SORBITAN SESQUIOLEATE, OZOKERITE, CALCIUM STEARATE, CETYL PEG/PPG-10/1 DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, TRIMETHYLSILOXYSILICATE, GLYCERYL, BEHENATE/EICOSADIOATE, METHYLPARABEN, CHLORPHENESIN, FRAGRANCE, TRIETHOXYCAPRYLYLSILANE, PROPYLPARABEN, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, LIMONENE, HONEY EXTRACT, BETA GLUCAN, BUTYLENE GLYCOL, PORTULACA OLERACEA EXTRACT, DIOSPYROS KAKI LEAF EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, GINKGO BILOBA LEAF EXTRACT



Section 51945-4

Section 55106-9

Active Ingredients:

TITANIUM DIOXIDE, ZINC OXIDE


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, GLYCERIN, ETHYLHEXYL METHOXYCINNAMATE, PEG-10 DIMETHICONE, HEXYL LAURATE, TALC, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, DIMETHICONE, ULTRAMARINES, SORBITAN SESQUIOLEATE, OZOKERITE, CALCIUM STEARATE, CETYL PEG/PPG-10/1 DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, TRIMETHYLSILOXYSILICATE, GLYCERYL, BEHENATE/EICOSADIOATE, METHYLPARABEN, CHLORPHENESIN, FRAGRANCE, TRIETHOXYCAPRYLYLSILANE, PROPYLPARABEN, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, LIMONENE, HONEY EXTRACT, BETA GLUCAN, BUTYLENE GLYCOL, PORTULACA OLERACEA EXTRACT, DIOSPYROS KAKI LEAF EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, GINKGO BILOBA LEAF EXTRACT



Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active Ingredients:

TITANIUM DIOXIDE, ZINC OXIDE


Advanced Ingredient Data


Raw Label Data

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