Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 41e058ac-2230-4047-8f6e-3054167a881b
Route
CUTANEOUS
Published
Effective Date 2010-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (5.5 mL) Titanium (2.25 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-04-01

Description

Active Ingredients: ZINC OXIDE, 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, ETHYLHEXYL METHOXYCINNAMATE, PEG-10 DIMETHICONE, DIPROPYLENE GLYCOL, DIMETHICONE, CETYL ETHYLHEXANOATE, MAGNESIUM SULFATE, QUATERNIUM-18 HECTORITE, DIMETHICONE CROSSPOLYMER, DIMETHICONE/PEG-10/15 CROSSPOLYMER, PANTHENOL, PONCIRUS TRIFOLIATA FRUIT EXTRACT, PORTULACA OLERACEA EXTRACT, SORBITAN SESQUIOLEATE, ZINC STEARATE, DIMETHICONE/METHICONE COPOLYMER, ALUMINUM HYDROXIDE, STEARIC ACID, METHYLPARABEN, FRAGRANCE, DISTEARYLDIMONIUM CHLORIDE, VP/EICOSENE COPOLYMER, MICA, ACRYLATES/DIMETHICONE COPOLYMER, NYLON-12, DIPOTASSIUM GLYCYRRHIZATE, ETHYLPARABEN, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, IRON OXIDES(CI 77492), VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, IRON OXIDES(CI 77491), TOCOPHERYL ACETATE, METHICONE, IRON OXIDES(CI 77499), TRIETHOXYCAPRYLYLSILANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ALCOHOL, GLYCERIN, ARGANIA SPINOSA KERNEL EXTRACT, RHEUM UNDULATUM ROOT/STALK/STEM EXTRACT, SODIUM COCOYL GLUTAMATE, CARBOMER, COPTIS CHINENSIS ROOT EXTRACT, CRAMBE MARITIMA EXTRACT



Section 51945-4

Section 55106-9

Active Ingredients: ZINC OXIDE, 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, ETHYLHEXYL METHOXYCINNAMATE, PEG-10 DIMETHICONE, DIPROPYLENE GLYCOL, DIMETHICONE, CETYL ETHYLHEXANOATE, MAGNESIUM SULFATE, QUATERNIUM-18 HECTORITE, DIMETHICONE CROSSPOLYMER, DIMETHICONE/PEG-10/15 CROSSPOLYMER, PANTHENOL, PONCIRUS TRIFOLIATA FRUIT EXTRACT, PORTULACA OLERACEA EXTRACT, SORBITAN SESQUIOLEATE, ZINC STEARATE, DIMETHICONE/METHICONE COPOLYMER, ALUMINUM HYDROXIDE, STEARIC ACID, METHYLPARABEN, FRAGRANCE, DISTEARYLDIMONIUM CHLORIDE, VP/EICOSENE COPOLYMER, MICA, ACRYLATES/DIMETHICONE COPOLYMER, NYLON-12, DIPOTASSIUM GLYCYRRHIZATE, ETHYLPARABEN, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, IRON OXIDES(CI 77492), VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, IRON OXIDES(CI 77491), TOCOPHERYL ACETATE, METHICONE, IRON OXIDES(CI 77499), TRIETHOXYCAPRYLYLSILANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ALCOHOL, GLYCERIN, ARGANIA SPINOSA KERNEL EXTRACT, RHEUM UNDULATUM ROOT/STALK/STEM EXTRACT, SODIUM COCOYL GLUTAMATE, CARBOMER, COPTIS CHINENSIS ROOT EXTRACT, CRAMBE MARITIMA EXTRACT



Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active Ingredients: ZINC OXIDE, TITANIUM DIOXIDE


Advanced Ingredient Data


Raw Label Data

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