Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID b1313caa-af81-4823-a019-8894fd0af52b
Route
CUTANEOUS
Published
Effective Date 2011-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (2.55 mL) Zinc Cation (1.4 mL)
Inactive Ingredients
Water Octinoxate Butylene Glycol Cyclomethicone Glycerin Betaine Sodium Chloride Dimethicone Aluminum Hydroxide Stearic Acid Zinc Stearate Methylparaben Allantoin Tomato Edetate Disodium Aluminum Silicate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-04-01

Description

Active Ingredients: TITANIUM DIOXIDE, ZINC OXIDE


Medication Information

Warnings and Precautions

Warnings:

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.

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

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

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

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

Indications and Usage

Indications and Usage:

Tighten the lid after using it.

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

Please apply it an adequate quantity  evenly on face, throat, arms and legs at the last stage of basic makeup.

Please apply it once again on your skin at the time when you're going out, sports activity, and any activities of outside.

Dosage and Administration

Dosage and Administration:

Take up about 1.2g - 1.5g of it and smooth over the entire face.

Description

Active Ingredients: TITANIUM DIOXIDE, ZINC OXIDE

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

Inactive ingredients:

Water, Ethylhexyl Methoxycinnamate, Butylene Glycol, C12-15 Alkyl Benzoate, Cyclomethicone, Disteardimonium Hectorite, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone,

Butylene Glycol Dicaprylate/Dicaprate, Bis-Ethylhexyloxyphenol Methoxyphenyltriazine, 4-Methylbenzylidene Camphor, Betaine, Sodium Chloride, Polyglyceryl-4-Isostearate,

Cetyl Dimethicone, Polymethyl Methacrylate, Dimethicone, Aluminum Hydroxide, Stearic Acid, Zinc Stearate, Portulaca Oleracea Extract, Methyl Paraben,

Tocopheryl Acetate, Allantoin, Punica Granatum Fruit Extract, Solanum Lycopersicum (Tomato) Fruit Extract, Disodium EDTA, Aluminum Silicate,

Zeolite, Topaz, Hematite Extract, Tourmaline, Flavor

Section 51945-4

Section 55105-1

Purpose:

Protects your skin from Ultra-violet Rays.

365 days with Esopinio Sun Shield Plus your skin will be safe.

Section 55106-9

Active Ingredients: TITANIUM DIOXIDE, ZINC OXIDE


Structured Label Content

Indications and Usage (34067-9)

Indications and Usage:

Tighten the lid after using it.

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

Please apply it an adequate quantity  evenly on face, throat, arms and legs at the last stage of basic makeup.

Please apply it once again on your skin at the time when you're going out, sports activity, and any activities of outside.

Dosage and Administration (34068-7)

Dosage and Administration:

Take up about 1.2g - 1.5g of it and smooth over the entire face.

Warnings and Precautions (34071-1)

Warnings:

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.

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

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

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

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

Section 50565-1 (50565-1)

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients:

Water, Ethylhexyl Methoxycinnamate, Butylene Glycol, C12-15 Alkyl Benzoate, Cyclomethicone, Disteardimonium Hectorite, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone,

Butylene Glycol Dicaprylate/Dicaprate, Bis-Ethylhexyloxyphenol Methoxyphenyltriazine, 4-Methylbenzylidene Camphor, Betaine, Sodium Chloride, Polyglyceryl-4-Isostearate,

Cetyl Dimethicone, Polymethyl Methacrylate, Dimethicone, Aluminum Hydroxide, Stearic Acid, Zinc Stearate, Portulaca Oleracea Extract, Methyl Paraben,

Tocopheryl Acetate, Allantoin, Punica Granatum Fruit Extract, Solanum Lycopersicum (Tomato) Fruit Extract, Disodium EDTA, Aluminum Silicate,

Zeolite, Topaz, Hematite Extract, Tourmaline, Flavor

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:

Protects your skin from Ultra-violet Rays.

365 days with Esopinio Sun Shield Plus your skin will be safe.

Section 55106-9 (55106-9)

Active Ingredients: TITANIUM DIOXIDE, ZINC OXIDE


Advanced Ingredient Data


Raw Label Data

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