SPL v1
SPL
SPL Set ID 07469133-4a35-4ff8-89a1-50b2257db118
Route
TOPICAL
Published
Effective Date 2012-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.76 g) Octinoxate (1.05 g) Zinc Oxide (0.66 g)
Inactive Ingredients
Water Cyclomethicone 5 Talc Dipropylene Glycol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-01-15

Description

Active Ingredients: TITANIUM DIOXIDE 7.9%, ETHYLHEXYL METHOXYCINNAMATE 3%, ZINC OXIDE 1.9%

Indications and Usage

How to Use: Apply an appropriate amount to the skin evenly.

Purpose

Purpose: This smooth foundation makes your skin feel soft as velvet texture.

Dosage and Administration

How to Use: Apply an appropriate amount to the skin evenly.


Medication Information

Indications and Usage

How to Use: Apply an appropriate amount to the skin evenly.

Purpose

Purpose: This smooth foundation makes your skin feel soft as velvet texture.

Dosage and Administration

How to Use: Apply an appropriate amount to the skin evenly.

Description

Active Ingredients: TITANIUM DIOXIDE 7.9%, ETHYLHEXYL METHOXYCINNAMATE 3%, ZINC OXIDE 1.9%

Warnings

Cautions:

For external use only.

Avoid contact with eyes and mouth.

Discontinue use if signs of irritation or rash appear.

Keep out of reach of children.

Replace the cap after use.

Active Ingredient

Active Ingredients: TITANIUM DIOXIDE 7.9%, ETHYLHEXYL METHOXYCINNAMATE 3%, ZINC OXIDE 1.9%

Inactive Ingredient

Inactive Ingredients:

WATER, CYCLOPENTASILOXANE, TALC, DIPROPYLENE GLYCOL, GLYCERIN, PEG-10 DIMETHICONE, CYCLOMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE, NIACINAMIDE, PHENYL TRIMETHICONE, IRON OXIDES, BETAINE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, HEXYL LAURATE, NELUMBO NUCIFERA FLOWER WATER, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, C12-14 PARETH-3, ACRYLATES/DIMETHICONE COPOLYMER, PHENOXYETHANOL, METHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SILICA, PALMITIC ACID, FRAGRANCE, METHYLPARABEN, PROPYLPARABEN, TOCOPHERYL ACETATE, PULSATILLA KOREANA EXTRACT, USNEA BARBATA (LICHEN) EXTRACT, ZANTHOXYLUM PIPERITUM FRUIT EXTRACT, DIOSPYROS KAKI LEAF EXTRACT, HYDROGENATED LECITHIN, RUBUS FRUTICOSUS (BLACKBERRY) FRUIT EXTRACT, SEA WATER, ACACIA SENEGAL FLOWER/STEM EXTRACT, ARNICA MONTANA FLOWER EXTRACT, CENTAUREA CYANUS FLOWER EXTRACT, DIANTHUS CARYOPHYLLUS FLOWER EXTRACT, FREESIA REFRACTA EXTRACT, IRIS VERSICOLOR EXTRACT, JASMINUM OFFICINALE (JASMINE) FLOWER/LEAF EXTRACT, ZANTEDESCHIA AETHIOPICA FLOWER/STEM EXTRACT,

HYDROGENATED VEGETABLE OIL, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, NEOFINETIA FALCATA CALLUS CULTURE EXTRACT, BUTYLPARABEN, ADENOSINE, SODIUM HYALURONATE, XANTHAN GUM, PEARL POWDER, ALUMINUM SILICATE, LECITHIN

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label. Principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: This smooth foundation makes your skin feel soft as velvet texture.

Warnings (WARNINGS)

Cautions:

For external use only.

Avoid contact with eyes and mouth.

Discontinue use if signs of irritation or rash appear.

Keep out of reach of children.

Replace the cap after use.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredients: TITANIUM DIOXIDE 7.9%, ETHYLHEXYL METHOXYCINNAMATE 3%, ZINC OXIDE 1.9%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

WATER, CYCLOPENTASILOXANE, TALC, DIPROPYLENE GLYCOL, GLYCERIN, PEG-10 DIMETHICONE, CYCLOMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE, NIACINAMIDE, PHENYL TRIMETHICONE, IRON OXIDES, BETAINE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, HEXYL LAURATE, NELUMBO NUCIFERA FLOWER WATER, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, C12-14 PARETH-3, ACRYLATES/DIMETHICONE COPOLYMER, PHENOXYETHANOL, METHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SILICA, PALMITIC ACID, FRAGRANCE, METHYLPARABEN, PROPYLPARABEN, TOCOPHERYL ACETATE, PULSATILLA KOREANA EXTRACT, USNEA BARBATA (LICHEN) EXTRACT, ZANTHOXYLUM PIPERITUM FRUIT EXTRACT, DIOSPYROS KAKI LEAF EXTRACT, HYDROGENATED LECITHIN, RUBUS FRUTICOSUS (BLACKBERRY) FRUIT EXTRACT, SEA WATER, ACACIA SENEGAL FLOWER/STEM EXTRACT, ARNICA MONTANA FLOWER EXTRACT, CENTAUREA CYANUS FLOWER EXTRACT, DIANTHUS CARYOPHYLLUS FLOWER EXTRACT, FREESIA REFRACTA EXTRACT, IRIS VERSICOLOR EXTRACT, JASMINUM OFFICINALE (JASMINE) FLOWER/LEAF EXTRACT, ZANTEDESCHIA AETHIOPICA FLOWER/STEM EXTRACT,

HYDROGENATED VEGETABLE OIL, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, NEOFINETIA FALCATA CALLUS CULTURE EXTRACT, BUTYLPARABEN, ADENOSINE, SODIUM HYALURONATE, XANTHAN GUM, PEARL POWDER, ALUMINUM SILICATE, LECITHIN

Indications and Usage (INDICATIONS AND USAGE)

How to Use: Apply an appropriate amount to the skin evenly.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

How to Use: Apply an appropriate amount to the skin evenly.

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)