SPL v1
SPL
SPL Set ID d3d0d005-4215-4133-ad8a-13833b86777a
Route
TOPICAL
Published
Effective Date 2015-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (5.62 mg) Zinc Cation (2.37 mg)
Inactive Ingredients
Dicaprylyl Carbonate Witch Hazel

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-07-01

Description

Active Ingredient: Titanium Dioxide 11.25%, Zinc oxide 4.75%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Indications & Usage: After washing the face & body, dispense an appropriate amount into your palm, and evenly apply to the entire face and body.

Dosage & Administration: Take an adequate amount of this product.

Warnings

Warnings: 1. Stop using the product if the following problems arise while using the product as continued use could worsen the symptoms; consult with a dermatologist. A. If red spots, swelling, itchiness, and irritation occur. B. If the above problems occur on the applied area on the skin from direct sunlight 2. Do not use on areas with wounds, eczema, and dermatitis. 3. Storage and handling precautions. A. Close the lid after use. B. Do not store in high- temperature or low- temperature and keep away from direct sunlight.

Active Ingredient

Active Ingredient: Titanium Dioxide 11.25%, Zinc oxide 4.75%

Inactive Ingredient

Inactive Ingredients: Centella Asiatica Extract, Dicaprylyl Carbonate, Hamamelis Virginiana (Witch Hazel) Water, Coco-Caprylate/Caprate, Polyglyceryl-3 Diisostearate, Stearic acid, Polyglyceryl-2 Dipolyhydroxystearate, Aluminum hydroxide, Glycerin, Glyceryl Caprylate, Centella Asiatica Leaf Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Galactomyces Ferment Filtrate, Bifida Ferment Lysate, Sodium Chloride, 1,2-Hexanediol, Helianthus Annuus (Sunflower) Seed Oil, Camellia Sinensis Leaf Extract, Sodium Hyaluronate, Persea Gratissima (Avocado) Oil, Usnea Barbata (Lichen) Extract, Isoamyl Laurate, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Silica, Sorbitan Olivate, Lactobacillus/Portulaca Oleracea Ferment Extract, Lactobacillus/Punica Granatum Fruit Ferment Extract, Lactobacillus/Pumpkin Ferment Extract, Bacillus/Soybean Ferment Extract, Aspergillus/Saccharomyces/ Barley Seed Ferment Extract, Saccharomyces/Grape Ferment Extract, Hippophae Rhamnoides Seed Oil, Rosa Canina Fruit Extract, Voacanga Africana Seed Extract, Aspergillus/Rice Ferment Extract, Ethyl Ferulate, Cocos Nucifera (Coconut) Oil, Citrus Aurantium Dulcis (Orange) Oil, Citrus Paradisi (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: 1. Stop using the product if the following problems arise while using the product as continued use could worsen the symptoms; consult with a dermatologist. A. If red spots, swelling, itchiness, and irritation occur. B. If the above problems occur on the applied area on the skin from direct sunlight 2. Do not use on areas with wounds, eczema, and dermatitis. 3. Storage and handling precautions. A. Close the lid after use. B. Do not store in high- temperature or low- temperature and keep away from direct sunlight.

Description (DESCRIPTION)

Indications & Usage: After washing the face & body, dispense an appropriate amount into your palm, and evenly apply to the entire face and body.

Dosage & Administration: Take an adequate amount of this product.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Titanium Dioxide 11.25%, Zinc oxide 4.75%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Centella Asiatica Extract, Dicaprylyl Carbonate, Hamamelis Virginiana (Witch Hazel) Water, Coco-Caprylate/Caprate, Polyglyceryl-3 Diisostearate, Stearic acid, Polyglyceryl-2 Dipolyhydroxystearate, Aluminum hydroxide, Glycerin, Glyceryl Caprylate, Centella Asiatica Leaf Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Galactomyces Ferment Filtrate, Bifida Ferment Lysate, Sodium Chloride, 1,2-Hexanediol, Helianthus Annuus (Sunflower) Seed Oil, Camellia Sinensis Leaf Extract, Sodium Hyaluronate, Persea Gratissima (Avocado) Oil, Usnea Barbata (Lichen) Extract, Isoamyl Laurate, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Silica, Sorbitan Olivate, Lactobacillus/Portulaca Oleracea Ferment Extract, Lactobacillus/Punica Granatum Fruit Ferment Extract, Lactobacillus/Pumpkin Ferment Extract, Bacillus/Soybean Ferment Extract, Aspergillus/Saccharomyces/ Barley Seed Ferment Extract, Saccharomyces/Grape Ferment Extract, Hippophae Rhamnoides Seed Oil, Rosa Canina Fruit Extract, Voacanga Africana Seed Extract, Aspergillus/Rice Ferment Extract, Ethyl Ferulate, Cocos Nucifera (Coconut) Oil, Citrus Aurantium Dulcis (Orange) Oil, Citrus Paradisi (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil

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


Advanced Ingredient Data


Raw Label Data

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