Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 49948094-0050-46a0-8848-967f81d5b797
Route
CUTANEOUS
Published
Effective Date 2010-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (3.25 mL)

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:

WATER, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, BUTYLENE GLYCOL, PEG-10 DIMETHICONE, IRON OXIDES(CI77492), ORYZA SATIVA (RICE) BRAN OIL,

CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE, GLYCERIN, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, SORBITAN SESQUIOLEATE, HEXYL LAURATE,

IRON OXIDES(CI77491), CETYL PEG/PPG-10/1 DIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TRIETHOXYCAPRYLYLSILANE, METHYLPARABEN, CHLORPHENESIN, TRIHYDROXYSTEARIN, IRON OXIDES(CI77499), ALUMINUM HYDROXIDE, CALCIUM STEARATE, FRAGRANCE, STEARIC ACID, METHYL METHACRYLATE CROSSPOLYMER, BETA GLUCAN, PROPYLPARABEN, CAMELLIA SINENSIS LEAF EXTRACT, PORTULACA OLERACEA EXTRACT, DISODIUM EDTA, DIOSPYROS KAKI LEAF EXTRACT, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, LIMONENE, HONEY EXTRACT, GINKGO BILOBA LEAF EXTRACT, PHENOXYETHANOL



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, CYCLOHEXASILOXANE, BUTYLENE GLYCOL, PEG-10 DIMETHICONE, IRON OXIDES(CI77492), ORYZA SATIVA (RICE) BRAN OIL,

CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE, GLYCERIN, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, SORBITAN SESQUIOLEATE, HEXYL LAURATE,

IRON OXIDES(CI77491), CETYL PEG/PPG-10/1 DIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TRIETHOXYCAPRYLYLSILANE, METHYLPARABEN, CHLORPHENESIN, TRIHYDROXYSTEARIN, IRON OXIDES(CI77499), ALUMINUM HYDROXIDE, CALCIUM STEARATE, FRAGRANCE, STEARIC ACID, METHYL METHACRYLATE CROSSPOLYMER, BETA GLUCAN, PROPYLPARABEN, CAMELLIA SINENSIS LEAF EXTRACT, PORTULACA OLERACEA EXTRACT, DISODIUM EDTA, DIOSPYROS KAKI LEAF EXTRACT, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, LIMONENE, HONEY EXTRACT, GINKGO BILOBA LEAF EXTRACT, PHENOXYETHANOL



Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active Ingredient: TITANIUM DIOXIDE


Advanced Ingredient Data


Raw Label Data

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