Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 8b076b59-e90b-4f78-851d-b13f407fc3af
Route
CUTANEOUS
Published
Effective Date 2010-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (4.01 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-04-01

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:



NELUMBO NUCIFERA FLOWER EXTRACT, CYCLOMETHICONE, ETHYLHEXYL METHOXYCINNAMATE, NEOPENTYL GLYCOL DIISONONANOATE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, MANNAN, CYCLOPENTASILOXANE, HYDROGENATED POLYDECENE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, LAURYL PEG-8 DIMETHICONE, DIMETHICONE CROSSPOLYMER, GLYCERIN, ALUMINA, SODIUM LACTATE, OCTYLDODECYL NEOPENTANOATE, DICAPRYLYL CARBONATE, CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE, GLYCERYL DIBEHENATE, TRIBEHENIN, GLYCERYL BEHENATE, CAPRYLIC/CAPRIC GLYCERIDES, LECITHIN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER,

C12-14 PARETH-12, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, DISTEARDIMONIUM HECTORITE, PROPYLENE CARBONATE, DIMETHICONE, TRIMETHYLSILOXYSILICATE,

POLYGLYCERYL-6 POLYRICINOLEATE, SILICA, METHICONE, CARTHAMUS TINCTORIUS (SAFFLOWER) FLOWER EXTRACT, CHRYSANTHEMUM MORIFOLIUM FLOWER EXTRACT, ALTHAEA ROSEA FLOWER EXTRACT, PAEONIA SUFFRUTICOSA ROOT EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, GARDENIA FLORIDA FRUIT EXTRACT, TRIETHOXYCAPRYLYLSILANE, XANTHAN GUM, PHASEOLUS RADIATUS SEED EXTRACT, BETULA PLATYPHYLLA JAPONICA BARK EXTRACT, RUMEX CRISPUS ROOT EXTRACT, NELUMBO NUCIFERA LEAF EXTRACT, LYCIUM CHINENSE ROOT EXTRACT, KOCHIA SCOPARIA FRUIT EXTRACT, LACTOBACILLUS/SACCHAROMYCES/CNIDII RHIZOMA ROOT/COPTIDIS RHIZOMA ROOT/CORN/ZIZYPHUS JUJUBA FRUIT FERMENT FILTRATE, ACHYRANTHES BIDENTATA ROOT EXTRACT, PORIA COCOS EXTRACT, POLYGONUM MULTIFLORUM ROOT EXTRACT, ANGELICA GIGAS ROOT EXTRACT, CUSCUTA JAPONICA SEED EXTRACT, LYCIUM CHINENSE FRUIT EXTRACT, PANAX GINSENG ROOT EXTRACT, CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, DISODIUM EDTA, FRAGRANCE, IRON OXIDES(CI77491,77492,77499)



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:



NELUMBO NUCIFERA FLOWER EXTRACT, CYCLOMETHICONE, ETHYLHEXYL METHOXYCINNAMATE, NEOPENTYL GLYCOL DIISONONANOATE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, MANNAN, CYCLOPENTASILOXANE, HYDROGENATED POLYDECENE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, LAURYL PEG-8 DIMETHICONE, DIMETHICONE CROSSPOLYMER, GLYCERIN, ALUMINA, SODIUM LACTATE, OCTYLDODECYL NEOPENTANOATE, DICAPRYLYL CARBONATE, CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE, GLYCERYL DIBEHENATE, TRIBEHENIN, GLYCERYL BEHENATE, CAPRYLIC/CAPRIC GLYCERIDES, LECITHIN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER,

C12-14 PARETH-12, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, DISTEARDIMONIUM HECTORITE, PROPYLENE CARBONATE, DIMETHICONE, TRIMETHYLSILOXYSILICATE,

POLYGLYCERYL-6 POLYRICINOLEATE, SILICA, METHICONE, CARTHAMUS TINCTORIUS (SAFFLOWER) FLOWER EXTRACT, CHRYSANTHEMUM MORIFOLIUM FLOWER EXTRACT, ALTHAEA ROSEA FLOWER EXTRACT, PAEONIA SUFFRUTICOSA ROOT EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, GARDENIA FLORIDA FRUIT EXTRACT, TRIETHOXYCAPRYLYLSILANE, XANTHAN GUM, PHASEOLUS RADIATUS SEED EXTRACT, BETULA PLATYPHYLLA JAPONICA BARK EXTRACT, RUMEX CRISPUS ROOT EXTRACT, NELUMBO NUCIFERA LEAF EXTRACT, LYCIUM CHINENSE ROOT EXTRACT, KOCHIA SCOPARIA FRUIT EXTRACT, LACTOBACILLUS/SACCHAROMYCES/CNIDII RHIZOMA ROOT/COPTIDIS RHIZOMA ROOT/CORN/ZIZYPHUS JUJUBA FRUIT FERMENT FILTRATE, ACHYRANTHES BIDENTATA ROOT EXTRACT, PORIA COCOS EXTRACT, POLYGONUM MULTIFLORUM ROOT EXTRACT, ANGELICA GIGAS ROOT EXTRACT, CUSCUTA JAPONICA SEED EXTRACT, LYCIUM CHINENSE FRUIT EXTRACT, PANAX GINSENG ROOT EXTRACT, CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, DISODIUM EDTA, FRAGRANCE, IRON OXIDES(CI77491,77492,77499)



Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active Ingredient: TITANIUM DIOXIDE


Advanced Ingredient Data


Raw Label Data

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