SPL v1
SPL
SPL Set ID cbc57201-e428-4027-ab85-36c82b670678
Route
TOPICAL
Published
Effective Date 2013-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (7 mg)
Inactive Ingredients
Niacinamide Dimethicone Diisostearyl Malate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-02-01

Description

Active ingredient: Glycerin 20%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active ingredient: Glycerin 20%

Warnings

Warnings:

1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.

2. Do not use on scarred skin, or if you have dermatitis or eczema.

Active Ingredient

Active ingredient: Glycerin 20%

Inactive Ingredient

Inactive ingredients:

Betula Platyphylla Japonica Juice, Ethyl Hexylmethoxycinnamate, Neopentyl Glycol Diheptanoate, Titanium Dioxide, Triethoxy Caprylylsilane, Cyclopentasiloxane, Cyclohexasiloxane, Hexyl Laurate, Peg-10 Dimethicone, Stearic Acid, Alumina, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone, Diisostearyl Malate, Cetyl Peg/Ppg-10/1 Dimethicone, Niacinamide, Butylene Glycol, Triethylhexanoin, Copernicia Cerifera (Carnauba) Wax, Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Extract, Sodium Chloride, Sodium Hyaluronate, Ozokerite, Polymethyl Methacrylate, Phenyl Trimethicone, Sorbitan Isostearate, Adenosine, Tocopheryl Acetate, Beta Glucan, Sodium Pca, Betain, Sorbitol, Glycine, Alanine, Proline, Serine, Threonine, Arginine, Lysine, Glutamic Acid, Biosaccharide Gum-1, Adansonia Digitata Seed Extract, Paeonia Lactiflora Root Extract, Convallaria Majalis Root Extract, Magnolia Liliflora Flower Extract, Lilium Candidum Flower Extract, Leontopodium Alpinum Flower/Leaf Extract, Euterpe Oleracrea Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Vaccinium Macrocaron (Cranberry) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Sambucus Nigra Fruit Extract, Copper Tripeptide-1, Placental Protein, Brassica Oleracea Italica (Broccoli) Extract, Medicago Sativa (Alfalfa) Extract, Brassica Oleracea Capitata (Cabbage) Leaf Extract, Triticum Vulgare (Wheat) Germ Extract, Brassica Campestris (Rapeseed) Extract, Raphanus Sativus (Radish) Seed Extract, Ceramide 3, Moringa Oleifera Seed Oil, Arnica Montana Flower Extract, Artemisia Absinthium Extract, Achillea Millefolium Extract, Gentiana Lutea Root Extract, Glycine Soja (Soybean) Sprout Extract, Phaseolus Radiatus Seed Extract, Coix Lacryma-Jobi Ma-Yuen Seed Extract, Sesamum Indicum (Sesame) Seed Extract, Oryza Sativa (Rice) Germ Extract, Hordeum Distichon (Barley) Extract, Polygonum Fagopyrum Seed Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Plantago Major Leaf Extract, Poria Cocos Extract, Coix Lacryma-Jobi Ma-Yuen Seed Extract, Angelica Gigas Extract, Polygonatum Odoratum Extract (And Astragalus Membranaceus Root Extract, Cornus Officinalis Fruit Extract, Artemisia Capillaris Leaf Extract, Rehmannia Glutinosa Root Extract, Butyrospermum Parkii(Shea Butter), Mangifera Indica (Mango) Seed Butter, Argania Spinosa Kernel Oil, Simmondsia Chinensis(Jojoba) Seed Oil, Hippophae Rhamnoides Oil, Gardenia Yellow Color, Gardenia Red, Theobroma Cacao(Cocoa) Extract, Mannitol, Iron Oxides, Shellac, Hydrogenated Lecithin, Boron Nitride, Acrylates/Ammonium Methacrylate Copolymer, Fragrance

Indications and Usage

Indications and Usage:

1. Always replace cap after use

2. Keep away from direct sunlight or heat.

Dosage and Administration

Dosage and Administration:

Apply a liberal amount onto face after applying activator or cleansing.

Tap applied face softly for better absorption.

Keep Out of Reach of Children

Keep out of reach of children:

Keep out of reach of babies and children

Package Label. Principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Skin Protectant

Warnings (WARNINGS)

Warnings:

1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.

2. Do not use on scarred skin, or if you have dermatitis or eczema.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredient: Glycerin 20%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Betula Platyphylla Japonica Juice, Ethyl Hexylmethoxycinnamate, Neopentyl Glycol Diheptanoate, Titanium Dioxide, Triethoxy Caprylylsilane, Cyclopentasiloxane, Cyclohexasiloxane, Hexyl Laurate, Peg-10 Dimethicone, Stearic Acid, Alumina, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone, Diisostearyl Malate, Cetyl Peg/Ppg-10/1 Dimethicone, Niacinamide, Butylene Glycol, Triethylhexanoin, Copernicia Cerifera (Carnauba) Wax, Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Extract, Sodium Chloride, Sodium Hyaluronate, Ozokerite, Polymethyl Methacrylate, Phenyl Trimethicone, Sorbitan Isostearate, Adenosine, Tocopheryl Acetate, Beta Glucan, Sodium Pca, Betain, Sorbitol, Glycine, Alanine, Proline, Serine, Threonine, Arginine, Lysine, Glutamic Acid, Biosaccharide Gum-1, Adansonia Digitata Seed Extract, Paeonia Lactiflora Root Extract, Convallaria Majalis Root Extract, Magnolia Liliflora Flower Extract, Lilium Candidum Flower Extract, Leontopodium Alpinum Flower/Leaf Extract, Euterpe Oleracrea Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Vaccinium Macrocaron (Cranberry) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Sambucus Nigra Fruit Extract, Copper Tripeptide-1, Placental Protein, Brassica Oleracea Italica (Broccoli) Extract, Medicago Sativa (Alfalfa) Extract, Brassica Oleracea Capitata (Cabbage) Leaf Extract, Triticum Vulgare (Wheat) Germ Extract, Brassica Campestris (Rapeseed) Extract, Raphanus Sativus (Radish) Seed Extract, Ceramide 3, Moringa Oleifera Seed Oil, Arnica Montana Flower Extract, Artemisia Absinthium Extract, Achillea Millefolium Extract, Gentiana Lutea Root Extract, Glycine Soja (Soybean) Sprout Extract, Phaseolus Radiatus Seed Extract, Coix Lacryma-Jobi Ma-Yuen Seed Extract, Sesamum Indicum (Sesame) Seed Extract, Oryza Sativa (Rice) Germ Extract, Hordeum Distichon (Barley) Extract, Polygonum Fagopyrum Seed Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Plantago Major Leaf Extract, Poria Cocos Extract, Coix Lacryma-Jobi Ma-Yuen Seed Extract, Angelica Gigas Extract, Polygonatum Odoratum Extract (And Astragalus Membranaceus Root Extract, Cornus Officinalis Fruit Extract, Artemisia Capillaris Leaf Extract, Rehmannia Glutinosa Root Extract, Butyrospermum Parkii(Shea Butter), Mangifera Indica (Mango) Seed Butter, Argania Spinosa Kernel Oil, Simmondsia Chinensis(Jojoba) Seed Oil, Hippophae Rhamnoides Oil, Gardenia Yellow Color, Gardenia Red, Theobroma Cacao(Cocoa) Extract, Mannitol, Iron Oxides, Shellac, Hydrogenated Lecithin, Boron Nitride, Acrylates/Ammonium Methacrylate Copolymer, Fragrance

Indications and Usage (INDICATIONS AND USAGE)

Indications and Usage:

1. Always replace cap after use

2. Keep away from direct sunlight or heat.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Dosage and Administration:

Apply a liberal amount onto face after applying activator or cleansing.

Tap applied face softly for better absorption.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children:

Keep out of reach of babies and children

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


Advanced Ingredient Data


Raw Label Data

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