Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f9e48ab7-6d60-41a0-94c6-f5c25ce971cc
Route
CUTANEOUS
Published
Effective Date 2010-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (1.36 mL)

Identifiers & Packaging

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

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, SD ALCOHOL 40-B, CYCLOMETHICONE, DICAPRYLYL CARBONATE, OCTYLDODECYL NEOPENTANOATE, SORBITAN STEARATE, SORBITYL LAURATE, DIPROPYLENE, GLYCOL, DIISOPROPYL ADIPATE, POTASSIUM CETYL PHOSPHATE, CETEARYL ALCOHOL, PEG-100 STEARATE,

GLYCERYL STEARATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, SILICA, METHICONE, RHEUM UNDULATUM ROOT/STALK/STEM EXTRACT, COPTIS CHINENSIS ROOT EXTRACT, GLYCERIN, ARGANIA SPINOSA KERNEL EXTRACT, CRAMBE MARITIMA EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, MORUS ALBA BARK EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, ALOE FEROX LEAF EXTRACT, ETHYLHEXYL SALICYLATE, ARCTIUM LAPPA ROOT EXTRACT, ARTEMISIA PRINCEPS LEAF EXTRACT, POLYESTER-5, STEARIC ACID, XANTHAN GUM, PINUS STROBUS BARK EXTRACT, BUTYL METHOXYDIBENZOYLMETHANE, HYDROGENATED LECITHIN, POLYGLYCERYL-6 POLYRICINOLEATE, ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER, 4-METHYLBENZYLIDENE CAMPHOR, ISOAMYL P-METHOXYCINNAMATE, CAPRYLIC/CAPRIC GLYCERIDES, DISODIUM EDTA, METHYLPARABEN POTASSIUM HYDROXIDE, FRAGRANCE



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, SD ALCOHOL 40-B, CYCLOMETHICONE, DICAPRYLYL CARBONATE, OCTYLDODECYL NEOPENTANOATE, SORBITAN STEARATE, SORBITYL LAURATE, DIPROPYLENE, GLYCOL, DIISOPROPYL ADIPATE, POTASSIUM CETYL PHOSPHATE, CETEARYL ALCOHOL, PEG-100 STEARATE,

GLYCERYL STEARATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, SILICA, METHICONE, RHEUM UNDULATUM ROOT/STALK/STEM EXTRACT, COPTIS CHINENSIS ROOT EXTRACT, GLYCERIN, ARGANIA SPINOSA KERNEL EXTRACT, CRAMBE MARITIMA EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, MORUS ALBA BARK EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, ALOE FEROX LEAF EXTRACT, ETHYLHEXYL SALICYLATE, ARCTIUM LAPPA ROOT EXTRACT, ARTEMISIA PRINCEPS LEAF EXTRACT, POLYESTER-5, STEARIC ACID, XANTHAN GUM, PINUS STROBUS BARK EXTRACT, BUTYL METHOXYDIBENZOYLMETHANE, HYDROGENATED LECITHIN, POLYGLYCERYL-6 POLYRICINOLEATE, ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER, 4-METHYLBENZYLIDENE CAMPHOR, ISOAMYL P-METHOXYCINNAMATE, CAPRYLIC/CAPRIC GLYCERIDES, DISODIUM EDTA, METHYLPARABEN POTASSIUM HYDROXIDE, FRAGRANCE



Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active Ingredient: TITANIUM DIOXIDE


Advanced Ingredient Data


Raw Label Data

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