SPL v1
SPL
SPL Set ID ec0425c6-b508-4a74-ac1b-9e2cc20cc4d1
Route
TOPICAL
Published
Effective Date 2013-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.90 mg) Octinoxate (1.50 mg) Zinc Cation (0.88 mg)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-10-01

Description

Active Ingredients: Titanium Dioxide(CI 77891) 9.69%, Ethylhexyl Methoxycinnamate 5%, Zinc Oxide(CI 77947) 2.94%

Indications and Usage

Indications and Usage: 1. Tighten the lid after using it. 2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3. Use it after basic skin care.

Purpose

Purpose: UV Protection, Skin Protectant

Dosage and Administration

Dosage and Administration: After basic skin care, gently apply an amount the size of a bean to the entire face using a finger.


Medication Information

Indications and Usage

Indications and Usage:

1. Tighten the lid after using it.

2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.

3. Use it after basic skin care.

Purpose

Purpose: UV Protection, Skin Protectant

Dosage and Administration

Dosage and Administration:

After basic skin care, gently apply an amount the size of a bean to the entire face using a finger.

Description

Active Ingredients: Titanium Dioxide(CI 77891) 9.69%, Ethylhexyl Methoxycinnamate 5%, Zinc Oxide(CI 77947) 2.94%

Warnings

Warnings:

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: Titanium Dioxide(CI 77891) 9.69%, Ethylhexyl Methoxycinnamate 5%, Zinc Oxide(CI 77947) 2.94%

Inactive Ingredient

Inactive Ingredients:

Water,Cyclopentasiloxane,Cyclohexasiloxane, Glycerin, Butylene Glycol Dicaprylate/Dicaprate,Phenyl Trimethicone, Niacinamide, Dicaprylyl Carbonate,Methylpropanediol, Cetyl PEG/PPG-10/1 Dimethicone,Pentylene Glyco,Silica, Dimethicone,Sodium Chloride,Sorbitan Isostearate,

Hexyl Laurate,Disteardimonium Hectorite,Tribehenin, Beeswax,Phenoxyethanol,Iron Oxides (CI 77492), Dimethicone Crosspolymer,Aluminum Hydroxide,Stearic Acid, Triethoxycaprylylsilane,Iron Oxides (CI 77491), Iron Oxides (CI 77499),Fragrance(Parfum),

Ethylhexylglycerin,Disodium EDTA, Adenosine, Butylene Glycol, Limnanthes Alba (Meadowfoam) Seed Oil,Ascorbyl Glucoside, Tocopheryl Acetate,Hydrolyzed Collagen,Ethylhexyl Palmitate, Glycine Soja (Soybean) Oil, Retinol,Linoleic Acid,Ceramide 3,

Tocopherol,Portulaca Oleracea Extract,Silica Dimethyl Silylate, Caprylyl Glycol,Sodium Hyaluronate, Hexylene Glycol

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: UV Protection, Skin Protectant

Warnings (WARNINGS)

Warnings:

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: Titanium Dioxide(CI 77891) 9.69%, Ethylhexyl Methoxycinnamate 5%, Zinc Oxide(CI 77947) 2.94%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

Water,Cyclopentasiloxane,Cyclohexasiloxane, Glycerin, Butylene Glycol Dicaprylate/Dicaprate,Phenyl Trimethicone, Niacinamide, Dicaprylyl Carbonate,Methylpropanediol, Cetyl PEG/PPG-10/1 Dimethicone,Pentylene Glyco,Silica, Dimethicone,Sodium Chloride,Sorbitan Isostearate,

Hexyl Laurate,Disteardimonium Hectorite,Tribehenin, Beeswax,Phenoxyethanol,Iron Oxides (CI 77492), Dimethicone Crosspolymer,Aluminum Hydroxide,Stearic Acid, Triethoxycaprylylsilane,Iron Oxides (CI 77491), Iron Oxides (CI 77499),Fragrance(Parfum),

Ethylhexylglycerin,Disodium EDTA, Adenosine, Butylene Glycol, Limnanthes Alba (Meadowfoam) Seed Oil,Ascorbyl Glucoside, Tocopheryl Acetate,Hydrolyzed Collagen,Ethylhexyl Palmitate, Glycine Soja (Soybean) Oil, Retinol,Linoleic Acid,Ceramide 3,

Tocopherol,Portulaca Oleracea Extract,Silica Dimethyl Silylate, Caprylyl Glycol,Sodium Hyaluronate, Hexylene Glycol

Indications and Usage

Indications and Usage:

1. Tighten the lid after using it.

2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.

3. Use it after basic skin care.

Dosage and Administration

Dosage and Administration:

After basic skin care, gently apply an amount the size of a bean to the entire face using a finger.

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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