SPL v1
SPL
SPL Set ID 571031fa-ed21-43c2-b24b-d2094606ca8f
Route
TOPICAL
Published
Effective Date 2014-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.15 g) Octinoxate (2.1 g) Zinc Cation (0.29 g)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-10-01

Description

Active ingredient: TITANIUM DIOXIDE 7.188%, ETHYLHEXYL METHOXYCINNAMATE 7.00%, ZINC OXIDE 0.985%

Purpose

PURPOSE: Sunscreen


Medication Information

Purpose

PURPOSE: Sunscreen

Description

Active ingredient: TITANIUM DIOXIDE 7.188%, ETHYLHEXYL METHOXYCINNAMATE 7.00%, ZINC OXIDE 0.985%

Use

USE:

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

Warning:

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging.

This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

Directions

DIRECTIONS:

Apply liberally 15 minutes before sun exposure.

Reapply at least every 2 hours. Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging.

To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses.

Children under 6 months of age: Ask a doctor.

Active Ingredient

Active ingredient: TITANIUM DIOXIDE 7.188%, ETHYLHEXYL METHOXYCINNAMATE 7.00%, ZINC OXIDE 0.985%

Other Information

Other information:

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredient

Inactive ingredient:

WATER, CYCLOPENTASILOXANE, CAPRYLYL METHICONE, METHYL TRIMETHICONE, GLYCERIN, PEG-10 DIMETHICONE, PHENYL TRIMETHICONE, ARBUTIN, DIPROPYLENE GLYCOL, TALC, DISTEARDIMONIUM HECTORITE, SODIUM CHLORIDE, BETAINE, CAPRYLYL GLYCOL, PYRUS MALUS (APPLE) FRUIT EXTRACT, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, SOLANUM LYCOPERSICUM (TOMATO) FRUIT EXTRACT, CUCURBITA PEPO (PUMPKIN) FRUIT EXTRACT, BRASSICA OLERACEA ITALICA (BROCCOLI) EXTRACT, BRASSICA OLERACEA CAPITATA (CABBAGE) LEAF EXTRACT, ASPARAGUS OFFICINALIS STEM EXTRACT, APIUM GRAVEOLENS (CELERY) EXTRACT, EUTERPE OLERACEA FRUIT EXTRACT, RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT, FRAGARIA CHILOENSIS (STRAWBERRY) FRUIT EXTRACT, VACCINIUM MACROCARPON (CRANBERRY) FRUIT EXTRACT, POLYGLYCERYL-6 POLYRICINOLEATE, DIMETHICONE, METHICONE, DIMETHICONE CROSSPOLYMER, SILICA SILYLATE, ASCORBYL TETRAISOPALMITATE, DIMETHICONE/METHICONE COPOLYMER, ARACHIS HYPOGAEA (PEANUT) OIL, RETINYL PALMITATE, ADENOSINE, TRIMETHYLSILOXYSILICATE, TRIETHOXYCAPRYLYLSILANE, TOCOPHERYL ACETATE, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499)

Keep Out of Reach of Children

Keep out of reach of children.

Package Label.principal Display Panel


Structured Label Content

Use (USE)

USE:

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Purpose (PURPOSE)

PURPOSE: Sunscreen

Warnings (WARNINGS)

Warning:

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging.

This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

Directions (DIRECTIONS)

DIRECTIONS:

Apply liberally 15 minutes before sun exposure.

Reapply at least every 2 hours. Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging.

To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses.

Children under 6 months of age: Ask a doctor.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredient: TITANIUM DIOXIDE 7.188%, ETHYLHEXYL METHOXYCINNAMATE 7.00%, ZINC OXIDE 0.985%

Other Information (Other information)

Other information:

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredient:

WATER, CYCLOPENTASILOXANE, CAPRYLYL METHICONE, METHYL TRIMETHICONE, GLYCERIN, PEG-10 DIMETHICONE, PHENYL TRIMETHICONE, ARBUTIN, DIPROPYLENE GLYCOL, TALC, DISTEARDIMONIUM HECTORITE, SODIUM CHLORIDE, BETAINE, CAPRYLYL GLYCOL, PYRUS MALUS (APPLE) FRUIT EXTRACT, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, SOLANUM LYCOPERSICUM (TOMATO) FRUIT EXTRACT, CUCURBITA PEPO (PUMPKIN) FRUIT EXTRACT, BRASSICA OLERACEA ITALICA (BROCCOLI) EXTRACT, BRASSICA OLERACEA CAPITATA (CABBAGE) LEAF EXTRACT, ASPARAGUS OFFICINALIS STEM EXTRACT, APIUM GRAVEOLENS (CELERY) EXTRACT, EUTERPE OLERACEA FRUIT EXTRACT, RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT, FRAGARIA CHILOENSIS (STRAWBERRY) FRUIT EXTRACT, VACCINIUM MACROCARPON (CRANBERRY) FRUIT EXTRACT, POLYGLYCERYL-6 POLYRICINOLEATE, DIMETHICONE, METHICONE, DIMETHICONE CROSSPOLYMER, SILICA SILYLATE, ASCORBYL TETRAISOPALMITATE, DIMETHICONE/METHICONE COPOLYMER, ARACHIS HYPOGAEA (PEANUT) OIL, RETINYL PALMITATE, ADENOSINE, TRIMETHYLSILOXYSILICATE, TRIETHOXYCAPRYLYLSILANE, TOCOPHERYL ACETATE, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499)

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)