SPL v2
SPL
SPL Set ID ac3da3c6-9be6-4eac-8b8d-6b56c8db9ca4
Route
TOPICAL
Published
Effective Date 2015-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (3.37 mg) Zinc Cation (1.47 mg)
Inactive Ingredients
Licorice

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-03-01

Description

Active Ingredient: Titanium Dioxide 11.25%, Zinc Oxide 4.90%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

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

Dosage & Administration: Use the eyedropper to pump 1~2times.

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. Keep away from the reach of babies and children. C. Do not store in high-temperature or low-temperature and keep away from direct sunlight 4. Wash off the product if it gets in the eye

Active Ingredient

Active Ingredient: Titanium Dioxide 11.25%, Zinc Oxide 4.90%

Inactive Ingredient

Inactive Ingredients: Glycyrrhiza Glabra (Licorice) Root Water, Camellia Sinensis Leaf Water, Aloe Barbadensis Leaf Water, Coco-Caprylate/Caprate, Dicaprylyl Carbonate, Polyglyceryl-3 Diisostearate, Glycerin, Isoamyl Laurate, Polyglyceryl-2 Dipolyhydroxyste arate, Sodium Chloride, Calen dula Officinalis Flower Extract, Sorbitan Olivate, NelumboNu cifera Flower Water, Centaurea Cyanus Flower Water, Lacto bacillus/Hibiscus Sabdariffa Flower Ferment Filtrate, Rosa Centifolia Flower Water, Zant hoxylum Piperitum Fruit Ext ract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Cocos Nucifera (Coco nut) Oil, Hippophae Rham no ides Seed Oil, Voacanga Afri cana Seed Extract, Rosa Cani na Fruit Extract, Yellow Oxide of Iron, alpha-bisabolol, Water, Morus Alba Bark Extract, Saccharomyces/Caragana Sinica Root Ferment Extract, Glycine Max (Soybean) Seed Extract, Chamomilla Recutita (Ma tricaria) Flower/Leaf Extract, Rosmarinus Officinalis (Rosemary) Extract, Lavandula Angustifolia (Lavender) Extract, Monarda Didyma Leaf Extract, Ocimum Basilicum (Basil) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Origanum Vulg are Leaf Extract, Mentha Viri dis (Spearmint) Extract, Melissa Officinalis Extract, Ethyl Ferulate, Oenothera Biennis (Evening Primrose) Oil, Borago Officinalis Seed Oil, Pistacia Vera Seed Oil, Red Oxide of Iron, Glyceryl Caprylate, Aluminum Hydroxide, stearic Acid, Citrus Aurantium Dulcis (Orange) Oil, Glycyrrhiza Glabra (Licorice) Root Extract, Rhodiola Rosea Root Extract, Rosa Damascena Flower Extract, Taraxacum Offi cinale (Dandelion) Leaf Extract, Olea Europaea (Olive) Leaf Extract, Mangifera Indica (Mango) Seed Butter, Argania Spinosa Kernel Oil, Black Oxide of Iron, Lavandula Angustifolia(Lavender) Oil, Adenosine

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. Keep away from the reach of babies and children. C. Do not store in high-temperature or low-temperature and keep away from direct sunlight 4. Wash off the product if it gets in the eye

Description (DESCRIPTION)

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

Dosage & Administration: Use the eyedropper to pump 1~2times.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Titanium Dioxide 11.25%, Zinc Oxide 4.90%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Glycyrrhiza Glabra (Licorice) Root Water, Camellia Sinensis Leaf Water, Aloe Barbadensis Leaf Water, Coco-Caprylate/Caprate, Dicaprylyl Carbonate, Polyglyceryl-3 Diisostearate, Glycerin, Isoamyl Laurate, Polyglyceryl-2 Dipolyhydroxyste arate, Sodium Chloride, Calen dula Officinalis Flower Extract, Sorbitan Olivate, NelumboNu cifera Flower Water, Centaurea Cyanus Flower Water, Lacto bacillus/Hibiscus Sabdariffa Flower Ferment Filtrate, Rosa Centifolia Flower Water, Zant hoxylum Piperitum Fruit Ext ract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Cocos Nucifera (Coco nut) Oil, Hippophae Rham no ides Seed Oil, Voacanga Afri cana Seed Extract, Rosa Cani na Fruit Extract, Yellow Oxide of Iron, alpha-bisabolol, Water, Morus Alba Bark Extract, Saccharomyces/Caragana Sinica Root Ferment Extract, Glycine Max (Soybean) Seed Extract, Chamomilla Recutita (Ma tricaria) Flower/Leaf Extract, Rosmarinus Officinalis (Rosemary) Extract, Lavandula Angustifolia (Lavender) Extract, Monarda Didyma Leaf Extract, Ocimum Basilicum (Basil) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Origanum Vulg are Leaf Extract, Mentha Viri dis (Spearmint) Extract, Melissa Officinalis Extract, Ethyl Ferulate, Oenothera Biennis (Evening Primrose) Oil, Borago Officinalis Seed Oil, Pistacia Vera Seed Oil, Red Oxide of Iron, Glyceryl Caprylate, Aluminum Hydroxide, stearic Acid, Citrus Aurantium Dulcis (Orange) Oil, Glycyrrhiza Glabra (Licorice) Root Extract, Rhodiola Rosea Root Extract, Rosa Damascena Flower Extract, Taraxacum Offi cinale (Dandelion) Leaf Extract, Olea Europaea (Olive) Leaf Extract, Mangifera Indica (Mango) Seed Butter, Argania Spinosa Kernel Oil, Black Oxide of Iron, Lavandula Angustifolia(Lavender) Oil, Adenosine

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


Advanced Ingredient Data


Raw Label Data

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