SPL v1
SPL
SPL Set ID 7445f1cc-572e-4a94-8c24-41c14e3bdfea
Route
TOPICAL
Published
Effective Date 2014-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (3.05 mg) Octinoxate (0.9 mg) Zinc Cation (0.57 mg)
Inactive Ingredients
Water Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-02-01

Description

Active Ingredients: Titanium Dioxide 10.17%, Ethylhexyl Methoxycinnamate 3.00%, Zinc Oxide 1.92%

Purpose

Purpose: Brightening, Wrinkle-Improvement, UV Protection


Medication Information

Purpose

Purpose: Brightening, Wrinkle-Improvement, UV Protection

Description

Active Ingredients: Titanium Dioxide 10.17%, Ethylhexyl Methoxycinnamate 3.00%, Zinc Oxide 1.92%

Cautions

Cautions:

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

Keep out of reach of children.

Replace the cap after use.

How to Use

How to Use:

After applying sun cream or makeup primer, gently shake the bottle and dispense 1-2 drops onto the back of your hands using the fountain pen filler.

Smooth on with foundation brush or your fingertips starting in the center of face, blending outwards.

Make sure the cap is tightly closed and shake 2-3 times before use.

Active Ingredient

Active Ingredients: Titanium Dioxide 10.17%, Ethylhexyl Methoxycinnamate 3.00%, Zinc Oxide 1.92%

Inactive Ingredient

Inactive Ingredients:

CYCLOPENTASILOXANE, WATER, ISODODECANE, DIMETHICONE, BUTYLENE GLYCOL, CAPRYLYL METHICONE, ALCOHOL, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, TALC, POLYMETHYLSILSESQUIOXANE, NIACINAMIDE, PEG-10 DIMETHICONE, SYNTHETIC FLUORPHLOGOPITE, IRON OXIDES(CI 77492), DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, ACRYLATES/DIMETHICONE COPOLYMER, PHENOXYETHANOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, METHICONE, FRAGRANCE, IRON OXIDES(CI 77491), AMINOPROPYL DIMETHICONE, ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, ALUMINA, ANGELICA KEISKEI EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, FOENICULUM VULGARE (FENNEL) LEAF EXTRACT, LAURUS NOBILIS LEAF EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER/LEAF/STEM EXTRACT, MENTHA PIPERITA (PEPPERMINT) EXTRACT,

PERILLA OCYMOIDES LEAF EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT, IRON OXIDES(CI 77499), ADENOSINE, TRIETHOXYCAPRYLYLSILANE, SILICA, ACRYLATES/TRIDECYL ACRYLATE/TRIETHOXYSILYLPROPYL METHACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, CELLULOSE, DIMETHICONE/METHICONE COPOLYMER, DIMETHICONOL, GOSSYPIUM HERBACEUM (COTTON) FRUIT WATER

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Brightening, Wrinkle-Improvement, UV Protection

Cautions

Cautions:

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

Keep out of reach of children.

Replace the cap after use.

How to Use

How to Use:

After applying sun cream or makeup primer, gently shake the bottle and dispense 1-2 drops onto the back of your hands using the fountain pen filler.

Smooth on with foundation brush or your fingertips starting in the center of face, blending outwards.

Make sure the cap is tightly closed and shake 2-3 times before use.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredients: Titanium Dioxide 10.17%, Ethylhexyl Methoxycinnamate 3.00%, Zinc Oxide 1.92%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

CYCLOPENTASILOXANE, WATER, ISODODECANE, DIMETHICONE, BUTYLENE GLYCOL, CAPRYLYL METHICONE, ALCOHOL, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, TALC, POLYMETHYLSILSESQUIOXANE, NIACINAMIDE, PEG-10 DIMETHICONE, SYNTHETIC FLUORPHLOGOPITE, IRON OXIDES(CI 77492), DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, ACRYLATES/DIMETHICONE COPOLYMER, PHENOXYETHANOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, METHICONE, FRAGRANCE, IRON OXIDES(CI 77491), AMINOPROPYL DIMETHICONE, ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, ALUMINA, ANGELICA KEISKEI EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, FOENICULUM VULGARE (FENNEL) LEAF EXTRACT, LAURUS NOBILIS LEAF EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER/LEAF/STEM EXTRACT, MENTHA PIPERITA (PEPPERMINT) EXTRACT,

PERILLA OCYMOIDES LEAF EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT, IRON OXIDES(CI 77499), ADENOSINE, TRIETHOXYCAPRYLYLSILANE, SILICA, ACRYLATES/TRIDECYL ACRYLATE/TRIETHOXYSILYLPROPYL METHACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, CELLULOSE, DIMETHICONE/METHICONE COPOLYMER, DIMETHICONOL, GOSSYPIUM HERBACEUM (COTTON) FRUIT WATER

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)