Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID de60727b-a136-4043-848d-60e7c48366ca
Route
CUTANEOUS
Published
Effective Date 2010-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (2.87 g) Zinc Cation (0.86 g)

Identifiers & Packaging

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

Description

Active Ingredients: TITANIUM DIOXIDE, ZINC OXIDE


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 WATER, PROPYLENE GLYCOL, CYCLOMETHICONE, TALC, DIMETHICONE, HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE,

HYDROGENATED POLY(C6-14 OLEFIN), ISOPROPYL PALMITATE, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE,

DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, ETHYLHEXYL METHOXYCINNAMATE, ARBUTIN, CETYL PEG/PPG-10/1 DIMETHICONE, MAGNESIUM SULFATE, POLYGLYCERYL-4 ISOSTEARATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SILICA, DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE, PORTULACA OLERACEA EXTRACT, TRIHYDROXYSTEARIN, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, IRON OXIDES(CI77492), PHENOXYETHANOL, DISTEARDIMONIUM HECTORITE, GLYCOSYL TREHALOSE, IRON OXIDES(CI77491), METHICONE, IRON OXIDES(CI77499), ALUMINUM HYDROXIDE, ALUMINUM STEARATE, METHYLPARABEN, HYDROGENATED STARCH HYDROLYSATE, PROPYLPARABEN, TOCOPHERYL ACETATE, GLYCINE SOJA (SOYBEAN) OIL, MADECASSOSIDE, GARDENIA FLORIDA FRUIT EXTRACT, ACHYRANTHES BIDENTATA ROOT EXTRACT, ALTHAEA ROSEA FLOWER EXTRACT, ANGELICA GIGAS ROOT EXTRACT, CHRYSANTHEMUM MORIFOLIUM FLOWER EXTRACT, CUSCUTA JAPONICA SEED EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, LYCIUM CHINENSE FRUIT EXTRACT, NELUMBO NUCIFERA FLOWER EXTRACT, POLYGONUM MULTIFLORUM ROOT EXTRACT, PORIA COCOS EXTRACT, PANAX GINSENG ROOT EXTRACT,

FRAGRANCE, BUTYLPARABEN, ADENOSINE, ALCOHOL, GLYCERIN, LECITHIN, SODIUM PHOSPHATE, HUMAN OLIGOPEPTIDE-1



Section 51945-4

Section 55106-9

Active Ingredients: TITANIUM DIOXIDE, ZINC OXIDE


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 WATER, PROPYLENE GLYCOL, CYCLOMETHICONE, TALC, DIMETHICONE, HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE,

HYDROGENATED POLY(C6-14 OLEFIN), ISOPROPYL PALMITATE, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE,

DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, ETHYLHEXYL METHOXYCINNAMATE, ARBUTIN, CETYL PEG/PPG-10/1 DIMETHICONE, MAGNESIUM SULFATE, POLYGLYCERYL-4 ISOSTEARATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SILICA, DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE, PORTULACA OLERACEA EXTRACT, TRIHYDROXYSTEARIN, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, IRON OXIDES(CI77492), PHENOXYETHANOL, DISTEARDIMONIUM HECTORITE, GLYCOSYL TREHALOSE, IRON OXIDES(CI77491), METHICONE, IRON OXIDES(CI77499), ALUMINUM HYDROXIDE, ALUMINUM STEARATE, METHYLPARABEN, HYDROGENATED STARCH HYDROLYSATE, PROPYLPARABEN, TOCOPHERYL ACETATE, GLYCINE SOJA (SOYBEAN) OIL, MADECASSOSIDE, GARDENIA FLORIDA FRUIT EXTRACT, ACHYRANTHES BIDENTATA ROOT EXTRACT, ALTHAEA ROSEA FLOWER EXTRACT, ANGELICA GIGAS ROOT EXTRACT, CHRYSANTHEMUM MORIFOLIUM FLOWER EXTRACT, CUSCUTA JAPONICA SEED EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, LYCIUM CHINENSE FRUIT EXTRACT, NELUMBO NUCIFERA FLOWER EXTRACT, POLYGONUM MULTIFLORUM ROOT EXTRACT, PORIA COCOS EXTRACT, PANAX GINSENG ROOT EXTRACT,

FRAGRANCE, BUTYLPARABEN, ADENOSINE, ALCOHOL, GLYCERIN, LECITHIN, SODIUM PHOSPHATE, HUMAN OLIGOPEPTIDE-1



Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active Ingredients: TITANIUM DIOXIDE, ZINC OXIDE


Advanced Ingredient Data


Raw Label Data

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