SPL v1
SPL
SPL Set ID 82d2a40f-475a-45bc-9c34-de5aab7c8686
Route
TOPICAL
Published
Effective Date 2016-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (2.5 g)
Inactive Ingredients
Green Tea Leaf Hydrogenated Soybean Lecithin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2016-01-02

Description

Active Ingredient: Glycerin 5.0%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active Ingredient: Glycerin 5.0%

Usage

Usage: Apply smoothly on the entire face in the morning and night.

Warnings

Warnings:

1. Stop usage immediately if any of the below symptoms occur. Continued use could aggravate symptoms, so it is advisable to consult with a dermatologist immediately. 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight

Active Ingredient

Active Ingredient: Glycerin 5.0%

Inactive Ingredient

Inactive Ingredients: Camellia Sinensis Leaf Extract, Hydrogenated Lecithin, Canola Oil, Helianthus Annuus (Sunflower) Seed Oil, Ethylhexyl Palmitate, Tremella Fuciformis Sporocarp Extract, Cyclomethicone, Cetearyl Alcohol, Glyceryl Stearate, Butylene Glycol, Hydrolyzed Collagen, Lactobacillus/Aspalathus Linearis Leaf Ferment Extract, Pinus Densiflora Bark Extract, Sodium Hyaluronate, Stearic Acid, Argania Spinosa Kernel Oil, Beeswax, Dimethicone, Pinus Palustris Leaf Extract, Citrus Grandis (Grapefruit) Seed Extract, Bambusa Textilis Stem Extract, Camellia Sinensis Catechins, Microcrystalline Wax, PEG-100 Stearate, Hydrolyzed Collagen, Tocopheryl Acetate, Arginine, Carbomer, Xanthan Gum, Disodium EDTA, Jasminum Officinale (Jasmine) Oil, Pinus Palustris Leaf Extract, Rosa Moschata Oil, Geranium Maculatum Oil, Cymbopogon Schoenanthus Oil

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Usage

Usage: Apply smoothly on the entire face in the morning and night.

Purpose (PURPOSE)

Purpose: Skin Protectant

Warnings (WARNINGS)

Warnings:

1. Stop usage immediately if any of the below symptoms occur. Continued use could aggravate symptoms, so it is advisable to consult with a dermatologist immediately. 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Glycerin 5.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Camellia Sinensis Leaf Extract, Hydrogenated Lecithin, Canola Oil, Helianthus Annuus (Sunflower) Seed Oil, Ethylhexyl Palmitate, Tremella Fuciformis Sporocarp Extract, Cyclomethicone, Cetearyl Alcohol, Glyceryl Stearate, Butylene Glycol, Hydrolyzed Collagen, Lactobacillus/Aspalathus Linearis Leaf Ferment Extract, Pinus Densiflora Bark Extract, Sodium Hyaluronate, Stearic Acid, Argania Spinosa Kernel Oil, Beeswax, Dimethicone, Pinus Palustris Leaf Extract, Citrus Grandis (Grapefruit) Seed Extract, Bambusa Textilis Stem Extract, Camellia Sinensis Catechins, Microcrystalline Wax, PEG-100 Stearate, Hydrolyzed Collagen, Tocopheryl Acetate, Arginine, Carbomer, Xanthan Gum, Disodium EDTA, Jasminum Officinale (Jasmine) Oil, Pinus Palustris Leaf Extract, Rosa Moschata Oil, Geranium Maculatum Oil, Cymbopogon Schoenanthus Oil

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

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