Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 57cd626b-4b6f-4059-a8e2-02b0f059fadb
Route
CUTANEOUS
Published
Effective Date 2010-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (5.55 mL) Zinc Cation (4.36 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-06-01

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:

BETULA PLATYPHYLLA JAPONICA JUICE, DICAPRYLYL CARBONATE, PROPANEDIOL, CYCLOMETHICONE, LAURYL PEG-8 DIMETHICONE, STEARIC ACID, ALUMINUM HYDROXIDE,

SODIUM CHLORIDE, CETYL DIMETHICONE, RHEUM UNDULATUM ROOT/STALK/STEM EXTRACT, COPTIS CHINENSIS ROOT EXTRACT, TRIHYDROXYSTEARIN, POLYGLYCERYL-6 POLYRICINOLEATE,

ROSA GALLICA FLOWER EXTRACT, ROSA DAMASCENA FLOWER OIL, EUCALYPTUS GLOBULUS LEAF EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, AESCULUS HIPPOCASTANUM (HORSE CHESTNUT) SEED EXTRACT,

RIBES NIGRUM (BLACK CURRANT) LEAF EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT, PADINA PAVONICA THALLUS EXTRACT, BUTYLENE GLYCOL,

CENTELLA ASIATICA EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, MIMOSA PUDICA LEAF EXTRACT, ECHINACEA ANGUSTIFOLIA EXTRACT, PINUS DENSIFLORA BARK EXTRACT,

SCROPHULARIA BUERGERIANA ROOT EXTRACT, NELUMBO NUCIFERA LEAF EXTRACT, LYCIUM CHINENSE ROOT EXTRACT, KOCHIA SCOPARIA FRUIT EXTRACT,

CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, CAPRYLIC/CAPRIC GLYCERIDES, METHYL METHACRYLATE CROSSPOLYMER, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE,

DIMETHICONE CROSSPOLYMER, DIMETHICONOL, WATER, GLYCERIN, PEG-10 DIMETHICONE, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), TRIETHOXYCAPRYLYLSILANE,

DISODIUM EDTA, FRAGRANCE



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:

BETULA PLATYPHYLLA JAPONICA JUICE, DICAPRYLYL CARBONATE, PROPANEDIOL, CYCLOMETHICONE, LAURYL PEG-8 DIMETHICONE, STEARIC ACID, ALUMINUM HYDROXIDE,

SODIUM CHLORIDE, CETYL DIMETHICONE, RHEUM UNDULATUM ROOT/STALK/STEM EXTRACT, COPTIS CHINENSIS ROOT EXTRACT, TRIHYDROXYSTEARIN, POLYGLYCERYL-6 POLYRICINOLEATE,

ROSA GALLICA FLOWER EXTRACT, ROSA DAMASCENA FLOWER OIL, EUCALYPTUS GLOBULUS LEAF EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, AESCULUS HIPPOCASTANUM (HORSE CHESTNUT) SEED EXTRACT,

RIBES NIGRUM (BLACK CURRANT) LEAF EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT, PADINA PAVONICA THALLUS EXTRACT, BUTYLENE GLYCOL,

CENTELLA ASIATICA EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, MIMOSA PUDICA LEAF EXTRACT, ECHINACEA ANGUSTIFOLIA EXTRACT, PINUS DENSIFLORA BARK EXTRACT,

SCROPHULARIA BUERGERIANA ROOT EXTRACT, NELUMBO NUCIFERA LEAF EXTRACT, LYCIUM CHINENSE ROOT EXTRACT, KOCHIA SCOPARIA FRUIT EXTRACT,

CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, CAPRYLIC/CAPRIC GLYCERIDES, METHYL METHACRYLATE CROSSPOLYMER, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE,

DIMETHICONE CROSSPOLYMER, DIMETHICONOL, WATER, GLYCERIN, PEG-10 DIMETHICONE, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), TRIETHOXYCAPRYLYLSILANE,

DISODIUM EDTA, FRAGRANCE



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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