SPL v2
SPL
SPL Set ID eae95288-0612-420e-a6dc-0f8a9694c133
Route
TOPICAL
Published
Effective Date 2018-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (2.01 mg) Titanium Dioxide (1.26 mg) Octisalate (0.75 mg)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-06-01

Description

Active Ingredients: Ethylhexyl Methoxycinnamate 6.7%, Titanium Dioxide 4.2%, Ethylhexyl Salicylate 2.5%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Active Ingredients: Ethylhexyl Methoxycinnamate 6.7%, Titanium Dioxide 4.2%, Ethylhexyl Salicylate 2.5%

Warnings

Warning:

1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.

1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.

2) In case of having the same symptoms above on the part you put this product on by direct sunlight.

2. you are banned to use it on the part where you have a scar, eczema, or dermatitis.

3. In case of getting it into your eyes, you have to wash it immediately.

Active Ingredient

Active Ingredients: Ethylhexyl Methoxycinnamate 6.7%, Titanium Dioxide 4.2%, Ethylhexyl Salicylate 2.5%

Inactive Ingredient

Inactive Ingredients:

Water,Butylene Glycol,Glycerin,Cyclopentasiloxane, Cyclohexasiloxane,Niacinamide,Dicaprylyl Carbonate,Cetyl Ethylhexanoate,Octyldodecanol,Diethylamino Hydroxybenzoyl Hexyl Benzoate, Diphenylsiloxy Phenyl Trimethicone,Mica (CI 77019),Triceteareth-4 Phosphate,Glycol Stearate, Phenoxyethanol Glyceryl Stearate,Potassium Cetyl

Phosphate,PEG-2 Stearate,PEG-100 Stearate,PEG-10 Dimethicone,Carbomer,Triethanolamine,Silica,Aluminum Hydroxide,Stearic Acid,Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer,Fragrance(Parfum),Isohexadecane,Ethylhexylglycerin, Triethoxycaprylylsilane,Xanthan Gum,Adenosine,Polysorbate 80,Iron Oxides (CI 77492),Disodium EDTA, Iron Oxides (CI 77491),Ultramarines (CI 77007), Snail Secretion Filtrate,Melissa Officinalis Leaf Extract, Malva Sylvestris (Mallow) Extract,Achillea Millefolium Extract,Alchemilla Vulgaris Extract, Primula Veris Extract,Mentha Piperita (Peppermint) Leaf Extract,Veronica Officinalis Extract,Vinegar Lavandula Angustifolia (Lavender) Extract,Rosmarinus Officinalis (Rosemary) Leaf Extract,Melaleuca Alternifolia (Tea Tree) Leaf Extract,Saccharomyces Ferment Filtrate

Indications and Usage

Indication and Usage: After skincare, apply appropriate amount on all over the face.

Dosage and Administration

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

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: Sunscreen

Warnings (WARNINGS)

Warning:

1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.

1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.

2) In case of having the same symptoms above on the part you put this product on by direct sunlight.

2. you are banned to use it on the part where you have a scar, eczema, or dermatitis.

3. In case of getting it into your eyes, you have to wash it immediately.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredients: Ethylhexyl Methoxycinnamate 6.7%, Titanium Dioxide 4.2%, Ethylhexyl Salicylate 2.5%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

Water,Butylene Glycol,Glycerin,Cyclopentasiloxane, Cyclohexasiloxane,Niacinamide,Dicaprylyl Carbonate,Cetyl Ethylhexanoate,Octyldodecanol,Diethylamino Hydroxybenzoyl Hexyl Benzoate, Diphenylsiloxy Phenyl Trimethicone,Mica (CI 77019),Triceteareth-4 Phosphate,Glycol Stearate, Phenoxyethanol Glyceryl Stearate,Potassium Cetyl

Phosphate,PEG-2 Stearate,PEG-100 Stearate,PEG-10 Dimethicone,Carbomer,Triethanolamine,Silica,Aluminum Hydroxide,Stearic Acid,Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer,Fragrance(Parfum),Isohexadecane,Ethylhexylglycerin, Triethoxycaprylylsilane,Xanthan Gum,Adenosine,Polysorbate 80,Iron Oxides (CI 77492),Disodium EDTA, Iron Oxides (CI 77491),Ultramarines (CI 77007), Snail Secretion Filtrate,Melissa Officinalis Leaf Extract, Malva Sylvestris (Mallow) Extract,Achillea Millefolium Extract,Alchemilla Vulgaris Extract, Primula Veris Extract,Mentha Piperita (Peppermint) Leaf Extract,Veronica Officinalis Extract,Vinegar Lavandula Angustifolia (Lavender) Extract,Rosmarinus Officinalis (Rosemary) Leaf Extract,Melaleuca Alternifolia (Tea Tree) Leaf Extract,Saccharomyces Ferment Filtrate

Indications and Usage (INDICATIONS AND USAGE)

Indication and Usage: After skincare, apply appropriate amount on all over the face.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

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

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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