SPL v1
SPL
SPL Set ID 3b760684-e46a-4383-80f8-ba5d2ce44b62
Route
TOPICAL
Published
Effective Date 2017-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (0.9 g)
Inactive Ingredients
Rosa Damascena Flower Oil Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-03-02

Description

Active ingredients: Dimethicone 2.0%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active ingredients: Dimethicone 2.0%

Warnings

Warnings: When using this product do not get into eyes, Stop use and ask a doctor if rash occurs. Do not use on - deep puncture wounds - animal bites - serious burns.

Active Ingredient

Active ingredients: Dimethicone 2.0%

Inactive Ingredient

Inactive ingredients: Rosa Damascena Flower Water, Water, Butylene Glycol, Diglycerin, Glycerin, Niacinamide, Methylpropanediol, Triethylhexanoin, 1,2-Hexanediol, Glyceryl Stearate, Caprylic/Capric Triglyceride, PEG-100 Stearate, Hdi/Trimethylol Hexyllactone Crosspolymer, Squalane, Phenoxyethanol, Polyacrylamide, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Ceramide NP,C13-14 Isoparaffin, Human Adipocyte Conditioned Media Extract, Ethylhexylglycerin, Phospholipids, Propanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Laureth-7, Phytosphingosine, Adenosine, Xanthan Gum, Caprylyl Glycol, Silica, Fragrance, Linum Usitatissimum(Linseed) Seed Extract, Phytosterols, Gardenia Florida Fruit Extract, Dextrin, Prunus Mume Fruit Extract, Nelumbo Nucifera Flower Extract,Tropolone,Hydrogenated Lecithin,Olea Europaea (Olive) Fruit Oil,Lecithin, Cetearyl Alcohol, Hydrolyzed Pea Protein, Stearic Acid, Butyrospermum Parkii(Shea Butter),Cholesterol, Ceramide EOP, Ceramide NS, Ceramide AP

Indications & Usage

Indications & Usage: Helps prevent and relieve chapped or cracked skin.

Dosage & Administration

Dosage & Administration: - Take a proper amount of product, and spread it evenly over the entire face. - Apply in daily skin care routine.

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Skin Protectant

Warnings (WARNINGS)

Warnings: When using this product do not get into eyes, Stop use and ask a doctor if rash occurs. Do not use on - deep puncture wounds - animal bites - serious burns.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Dimethicone 2.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Rosa Damascena Flower Water, Water, Butylene Glycol, Diglycerin, Glycerin, Niacinamide, Methylpropanediol, Triethylhexanoin, 1,2-Hexanediol, Glyceryl Stearate, Caprylic/Capric Triglyceride, PEG-100 Stearate, Hdi/Trimethylol Hexyllactone Crosspolymer, Squalane, Phenoxyethanol, Polyacrylamide, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Ceramide NP,C13-14 Isoparaffin, Human Adipocyte Conditioned Media Extract, Ethylhexylglycerin, Phospholipids, Propanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Laureth-7, Phytosphingosine, Adenosine, Xanthan Gum, Caprylyl Glycol, Silica, Fragrance, Linum Usitatissimum(Linseed) Seed Extract, Phytosterols, Gardenia Florida Fruit Extract, Dextrin, Prunus Mume Fruit Extract, Nelumbo Nucifera Flower Extract,Tropolone,Hydrogenated Lecithin,Olea Europaea (Olive) Fruit Oil,Lecithin, Cetearyl Alcohol, Hydrolyzed Pea Protein, Stearic Acid, Butyrospermum Parkii(Shea Butter),Cholesterol, Ceramide EOP, Ceramide NS, Ceramide AP

Indications & Usage (INDICATIONS & USAGE)

Indications & Usage: Helps prevent and relieve chapped or cracked skin.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Dosage & Administration: - Take a proper amount of product, and spread it evenly over the entire face. - Apply in daily skin care routine.

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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