Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 44e75905-613c-44b9-b8cc-06e7877a0a24
Route
CUTANEOUS
Published
Effective Date 2010-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (1.45 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-06-01

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, PROPYLENE GLYCOL, ETHYLHEXYL METHOXYCINNAMATE, SILICA, NEOPENTYL GLYCOL DIHEPTANOATE, ARBUTIN, PHENYLBENZIMIDAZOLE SULFONIC ACID, CYCLOMETHICONE, LAURYL PEG-8 DIMETHICONE, SODIUM CHLORIDE, BUTYL METHOXYDIBENZOYLMETHANE, PEG-10 DIMETHICONE, RHODIOLA ROSEA ROOT EXTRACT, RUBUS COREANUS FRUIT EXTRACT, RED GINSENG EXTRACT, ZIZYPHUS, JUJUBA FRUIT EXTRACT, AESCULUS HIPPOCASTANUM (HORSE CHESTNUT) SEED EXTRACT, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PROPYLENE CARBONATE, DISTEARDIMONIUM HECTORITE, POLYGLYCERYL-6 POLYRICINOLEATE, DICAPRYLYL CARBONATE, OCTYLDODECYL NEOPENTANOATE, LECITHIN, SORBITAN SESQUIOLEATE, STEARALKONIUM HECTORITE, GLYCERIN, HESPERIDIN METHYL CHALCONE, STEARETH-20, DIPEPTIDE-2, PALMITOYL TETRAPEPTIDE-7, PENTYLENE GLYCOL, METHICONE, ADENOSINE, SODIUM METABISULFITE, SODIUM HYDROXIDE, TRIETHANOLAMINE, TRIETHOXYCAPRYLYLSILANE, METHYL METHACRYLATE CROSSPOLYMER, METHYLPARABEN, DISODIUM EDTA, IRON OXIDES(CI 77491, CI 77492, CI 77499), 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, PROPYLENE GLYCOL, ETHYLHEXYL METHOXYCINNAMATE, SILICA, NEOPENTYL GLYCOL DIHEPTANOATE, ARBUTIN, PHENYLBENZIMIDAZOLE SULFONIC ACID, CYCLOMETHICONE, LAURYL PEG-8 DIMETHICONE, SODIUM CHLORIDE, BUTYL METHOXYDIBENZOYLMETHANE, PEG-10 DIMETHICONE, RHODIOLA ROSEA ROOT EXTRACT, RUBUS COREANUS FRUIT EXTRACT, RED GINSENG EXTRACT, ZIZYPHUS, JUJUBA FRUIT EXTRACT, AESCULUS HIPPOCASTANUM (HORSE CHESTNUT) SEED EXTRACT, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PROPYLENE CARBONATE, DISTEARDIMONIUM HECTORITE, POLYGLYCERYL-6 POLYRICINOLEATE, DICAPRYLYL CARBONATE, OCTYLDODECYL NEOPENTANOATE, LECITHIN, SORBITAN SESQUIOLEATE, STEARALKONIUM HECTORITE, GLYCERIN, HESPERIDIN METHYL CHALCONE, STEARETH-20, DIPEPTIDE-2, PALMITOYL TETRAPEPTIDE-7, PENTYLENE GLYCOL, METHICONE, ADENOSINE, SODIUM METABISULFITE, SODIUM HYDROXIDE, TRIETHANOLAMINE, TRIETHOXYCAPRYLYLSILANE, METHYL METHACRYLATE CROSSPOLYMER, METHYLPARABEN, DISODIUM EDTA, IRON OXIDES(CI 77491, CI 77492, CI 77499), 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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