Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 356f526b-d402-41e6-a8b5-339b8c610dd1
Route
CUTANEOUS
Published
Effective Date 2011-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (3.5 g)
Inactive Ingredients
Water Cyclomethicone Butylene Glycol Dimethicone Glycerin Carbomer 934 Polysorbate 20 Silicon Dioxide Octinoxate Stearic Acid Aluminum Hydroxide Sodium Chloride Zinc Stearate Betaine Butylparaben Methylparaben Allantoin Chamaemelum Nobile Wine Grape Aluminum Silicate

Identifiers & Packaging

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

Description

Active ingredient: TITANIUM DIOXIDE


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.

Use it at the time before you're going out after applying the Animating Water Cream.

Dosage and Administration

Dosage and administration:

Take up about  0.3g - 0.5g of it  and smooth over the entire face.

Description

Active ingredient: TITANIUM DIOXIDE

Section 50565-1

Keep out of reach of children:

Keep out of the reach of babies and children.

Section 51727-6

Inactive ingredients:

Water, Cyclomethicone, Butylene Glycol, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Cyclomethicone/Dimethicone Crosspolymer, Butylene Glycol Dicaprylate/Dicaprate, Glycerin, Carbomer, Polysorbate 20, Palmitoyl Pentapeptide-4, Polyglyceryl-4-Isostearate, Silica, Ethylhexyl Methoxycinnamate, Micronized Titanium Dioxide Aluminum Hydroxide Stearic Acid, Sodium Chloride, Portulaca Oleracea Extract, Zinc Stearate, Betaine, Silica Dimethyl Silylate, Iron Oxide, Butyl Paraben, Methyl Paraben, Tocopheryl Acetate, Allantoin, Flavor, Anthemis Nobilis Flower Extract, Punica Granatum Extract, Vitis Vinifera(Grape) Seed Extract, Hematite Extract, Aluminum Silicate, Topaz, Amethyst Powder, Zeolite



Section 51945-4

Section 55105-1

Purpose: It protects the skin from UV rays, pollution and dust.

Section 55106-9

Active ingredient: TITANIUM DIOXIDE


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.

Use it at the time before you're going out after applying the Animating Water Cream.

Dosage and Administration (34068-7)

Dosage and administration:

Take up about  0.3g - 0.5g 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 the reach of babies and children.

Section 51727-6 (51727-6)

Inactive ingredients:

Water, Cyclomethicone, Butylene Glycol, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Cyclomethicone/Dimethicone Crosspolymer, Butylene Glycol Dicaprylate/Dicaprate, Glycerin, Carbomer, Polysorbate 20, Palmitoyl Pentapeptide-4, Polyglyceryl-4-Isostearate, Silica, Ethylhexyl Methoxycinnamate, Micronized Titanium Dioxide Aluminum Hydroxide Stearic Acid, Sodium Chloride, Portulaca Oleracea Extract, Zinc Stearate, Betaine, Silica Dimethyl Silylate, Iron Oxide, Butyl Paraben, Methyl Paraben, Tocopheryl Acetate, Allantoin, Flavor, Anthemis Nobilis Flower Extract, Punica Granatum Extract, Vitis Vinifera(Grape) Seed Extract, Hematite Extract, Aluminum Silicate, Topaz, Amethyst Powder, Zeolite



Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: It protects the skin from UV rays, pollution and dust.

Section 55106-9 (55106-9)

Active ingredient: TITANIUM DIOXIDE


Advanced Ingredient Data


Raw Label Data

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