Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID df89f414-d593-443e-8905-cbfa573255f8
Route
CUTANEOUS
Published
Effective Date 2010-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (1.02 g) Zinc Cation (0.35 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.

Section 51727-6

Inactive ingredients:



WATER, TALC, MICA(CI 77019), SILICA, NYLON-12, ETHYLHEXYL METHOXYCINNAMATE, BORON NITRIDE, METHYL METHACRYLATE CROSSPOLYMER, TRIMETHYLOLPROPANE TRIETHYLHEXANOATE, TRIETHYLHEXANOIN, MAGNESIUM MYRISTATE, IRON OXIDES(CI 77492), DIMETHICONE, MAGNESIUM STEARATE, METHICONE, CALCIUM CARBONATE, IRON OXIDES(CI77491), HYDROGENATED, LECITHIN, METHYLPARABEN, FRAGRANCE, BUTYLPARABEN, IRON OXIDES(CI 77499), SYNTHETIC BEESWAX, ULTRAMARINES(CI 77007), BISMUTH OXYCHLORIDE(CI77163), NELUMBO NUCIFERA FLOWER EXTRACT, TRIETHOXYCAPRYLYLSILANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, LYCIUM CHINENSE FRUIT EXTRACT, ANGELICA GIGAS ROOT EXTRACT, PORIA COCOS EXTRACT, CUSCUTA JAPONICA SEED EXTRACT, ACHYRANTHES BIDENTATA ROOT EXTRACT, PANAX GINSENG ROOT EXTRACT, PHENOXYETHANOL, BUTYLENE GLYCOL, CHRYSANTHEMUM MORIFOLIUM FLOWER EXTRACT, JASMINUM OFFICINALE (JASMINE) OIL, ALTHAEA ROSEA FLOWER EXTRACT, ETHYLPARABEN, ISOBUTYLPARABEN, PROPYLPARABEN, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, LOTUS CORNICULATUS FLOWER EXTRACT, DEXTRIN, MONASCUS EXTRACT, GARDENIA FLORIDA FRUIT EXTRACT, SORGHUM VULGARE SEED/SKIN/STALK EXTRACT, CARTHAMUS TINCTORIUS (SAFFLOWER) FLOWER EXTRACT



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.

Section 51727-6 (51727-6)

Inactive ingredients:



WATER, TALC, MICA(CI 77019), SILICA, NYLON-12, ETHYLHEXYL METHOXYCINNAMATE, BORON NITRIDE, METHYL METHACRYLATE CROSSPOLYMER, TRIMETHYLOLPROPANE TRIETHYLHEXANOATE, TRIETHYLHEXANOIN, MAGNESIUM MYRISTATE, IRON OXIDES(CI 77492), DIMETHICONE, MAGNESIUM STEARATE, METHICONE, CALCIUM CARBONATE, IRON OXIDES(CI77491), HYDROGENATED, LECITHIN, METHYLPARABEN, FRAGRANCE, BUTYLPARABEN, IRON OXIDES(CI 77499), SYNTHETIC BEESWAX, ULTRAMARINES(CI 77007), BISMUTH OXYCHLORIDE(CI77163), NELUMBO NUCIFERA FLOWER EXTRACT, TRIETHOXYCAPRYLYLSILANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, LYCIUM CHINENSE FRUIT EXTRACT, ANGELICA GIGAS ROOT EXTRACT, PORIA COCOS EXTRACT, CUSCUTA JAPONICA SEED EXTRACT, ACHYRANTHES BIDENTATA ROOT EXTRACT, PANAX GINSENG ROOT EXTRACT, PHENOXYETHANOL, BUTYLENE GLYCOL, CHRYSANTHEMUM MORIFOLIUM FLOWER EXTRACT, JASMINUM OFFICINALE (JASMINE) OIL, ALTHAEA ROSEA FLOWER EXTRACT, ETHYLPARABEN, ISOBUTYLPARABEN, PROPYLPARABEN, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, LOTUS CORNICULATUS FLOWER EXTRACT, DEXTRIN, MONASCUS EXTRACT, GARDENIA FLORIDA FRUIT EXTRACT, SORGHUM VULGARE SEED/SKIN/STALK EXTRACT, CARTHAMUS TINCTORIUS (SAFFLOWER) FLOWER EXTRACT



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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