Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 9842c485-9f9e-463a-b7ae-9c3ede3c84ba
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, CYCLOMETHICONE, DIPROPYLENE GLYCOL, ETHYLHEXYL METHOXYCINNAMATE, GLYCERIN, CETEARYL ALCOHOL, OCTYLDODECYL NEOPENTANOATE, DICAPRYLYL CARBONATE, POTASSIUM CETYL PHOSPHATE, TRICETEARETH-4 PHOSPHATE, GLYCOL STEARATE, PEG-2 STEARATE, POLYETHYLENE, GLYCERYL STEARATE, PEG-100 STEARATE, STEARIC ACID, POLYGLYCERYL-6 POLYRICINOLEATE, RHEUM UNDULATUM ROOT/STALK/STEM EXTRACT, COPTIS CHINENSIS ROOT EXTRACT, XANTHAN GUM, POLYESTER-5, CAPRYLIC/CAPRIC GLYCERIDES, CAPRYLIC/CAPRIC TRIGLYCERIDE, CRAMBE MARITIMA EXTRACT, CARAPA GUAIANENSIS SEED OIL, ARGANIA SPINOSA KERNEL EXTRACT, HYDROGENATED LECITHIN, SILICA, METHICONE, ACRYLATES/ACRYLAMIDE COPOLYMER, MINERAL OIL, POLYSORBATE 85, ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER, TRIETHANOLAMINE, METHYLPARABEN, DISODIUM EDTA, ETHYLHEXYL SALICYLATE, ISOAMYL-p METHOXYCINNAMATE, 4-METHYLBENZYLIDENE CAMPHOR, BUTYL METHOXYDIBENZOYLMETHANE, FRAGRANCE, ALPHA-ISOMETHYL IONONE, BENTYL BENZOATE, BUTYLPHENY METHYLPROPIONAL, CITRONELLOL, HEXYL CINNAMAL,  LIMONENE, LINALOOL



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, CYCLOMETHICONE, DIPROPYLENE GLYCOL, ETHYLHEXYL METHOXYCINNAMATE, GLYCERIN, CETEARYL ALCOHOL, OCTYLDODECYL NEOPENTANOATE, DICAPRYLYL CARBONATE, POTASSIUM CETYL PHOSPHATE, TRICETEARETH-4 PHOSPHATE, GLYCOL STEARATE, PEG-2 STEARATE, POLYETHYLENE, GLYCERYL STEARATE, PEG-100 STEARATE, STEARIC ACID, POLYGLYCERYL-6 POLYRICINOLEATE, RHEUM UNDULATUM ROOT/STALK/STEM EXTRACT, COPTIS CHINENSIS ROOT EXTRACT, XANTHAN GUM, POLYESTER-5, CAPRYLIC/CAPRIC GLYCERIDES, CAPRYLIC/CAPRIC TRIGLYCERIDE, CRAMBE MARITIMA EXTRACT, CARAPA GUAIANENSIS SEED OIL, ARGANIA SPINOSA KERNEL EXTRACT, HYDROGENATED LECITHIN, SILICA, METHICONE, ACRYLATES/ACRYLAMIDE COPOLYMER, MINERAL OIL, POLYSORBATE 85, ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER, TRIETHANOLAMINE, METHYLPARABEN, DISODIUM EDTA, ETHYLHEXYL SALICYLATE, ISOAMYL-p METHOXYCINNAMATE, 4-METHYLBENZYLIDENE CAMPHOR, BUTYL METHOXYDIBENZOYLMETHANE, FRAGRANCE, ALPHA-ISOMETHYL IONONE, BENTYL BENZOATE, BUTYLPHENY METHYLPROPIONAL, CITRONELLOL, HEXYL CINNAMAL,  LIMONENE, LINALOOL



Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active Ingredient: TITANIUM DIOXIDE


Advanced Ingredient Data


Raw Label Data

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