71b73c2e-bdb8-4202-b491-42f2b7881e05

SPL v1
SPL
SPL Set ID 71b73c2e-bdb8-4202-b491-42f2b7881e05
Route
topical
Published
Effective Date 2014-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (0.36 g)
Inactive Ingredients
petrolatum silica dimethyl silylate

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2014-05-01

Purpose

Purpose: Sunscreen

Description

Active Ingredient: Ethylhexyl Methoxycinnamate 5%


Medication Information

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.

Purpose

Purpose: Sunscreen

Description

Active Ingredient: Ethylhexyl Methoxycinnamate 5%

Active Ingredient

Active Ingredient: Ethylhexyl Methoxycinnamate 5%

Inactive Ingredient

Inactive Ingredients:

Polyglyceryl-2 Triisostearate, Polybutene, Diisostearyl Malate, Petrolatum, Pentaerythrityl Tetraethylhexanoate, Microcrystalline Wax, Benzophenone-3, Hydroxystearic Acid, Silica Dimethyl Silylate, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Glyceryl Behenate, Polyglyceryl-6 Octastearate, Fragrance(Parfum), Butylparaben, Tocopheryl Acetate, Yellow 6 Lake (CI 15985), Water, Honey Extract

Indications and Usage

Indications and usage: Melt onto fingers and softly spread it on the lips

Dosage and Administration

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

Keep Out of Reach of Children

Keep out of reach of babies and children

Package Label.principal Display Panel


Structured Label Content

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.

Purpose (PURPOSE)

Purpose: Sunscreen

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Ethylhexyl Methoxycinnamate 5%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

Polyglyceryl-2 Triisostearate, Polybutene, Diisostearyl Malate, Petrolatum, Pentaerythrityl Tetraethylhexanoate, Microcrystalline Wax, Benzophenone-3, Hydroxystearic Acid, Silica Dimethyl Silylate, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Glyceryl Behenate, Polyglyceryl-6 Octastearate, Fragrance(Parfum), Butylparaben, Tocopheryl Acetate, Yellow 6 Lake (CI 15985), Water, Honey Extract

Indications and Usage (INDICATIONS AND USAGE)

Indications and usage: Melt onto fingers and softly spread it on the lips

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 babies and children

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


Advanced Ingredient Data


Raw Label Data

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