Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 8f9e3f16-a967-4143-9f1b-2c0d704a3c75
Route
CUTANEOUS
Published
Effective Date 2010-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (1.18 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-04-01

Description

Active Ingredient: TITANIUM DIOXIDE


Medication Information

Description

Directions:

When you use or do leisure, apply reasonable amount on your body exposed to UV including face, neck, arms, and legs at your finishing step of basic makeup.

Take more frequent reapplication for longtime outdoor activities.



Notice for use:

1. Discontinue if the following symptom appears and consult with dermatologist for the continuos problem of use.

  1) Discontinue use if redness, rash, irritation or tingling appears.

  2) Discontinue if the above symptom appears by a direct sunlight on the applied part.

2. Avoid the part for a cut, eczema or dermatitis.

3. Please note for keeping and handling.

  1) To keep the freshness, please close the lid after the use.

  2) Keep this and all drugs out of reach of children.

  3) Do not store this product in a place of high or low temperature. Do not expose it to the direct sunlight.

  4) Be careful, it may be slipper when contact with the product.

  5) Be careful not to make contacts with clothes.

  6) Be careful not to give a shock since the container may be broken and get injured.

  7) UV cutoff rating and SPF rating A of this product was measured in accordance with UV cutoff rating effect and methods examined by Korea Food and Drug Administration.

Section 51727-6

Inactive Ingredients:

Water, Cyclopentasiloxane, Ethylhexyl Methoxycinnamate, Cetyl Ethylhexanoate, Cyclomethicone, Dipropylene Glycol, 4-Methylbenzylidene Camphor, PEG-9 Polydimethylsiloxyethyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Sorbitan Sesquioleate, Disteardimonium Hectorite, Benzophenone-3, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol,

Glyceryl Behenate/Eicosadioate, Sodium Chloride, PEG-10 Dimethicone, Phenoxyethanol, Dimethicone Crosspolymer, Stearic Acid, Aluminum Hydroxide, Fragrance,

Butylparaben, Tocopheryl Acetate, Oryza Sativa (Rice) Bran Oil, Cellulose Gum, Ethylparaben, Methylparaben, Allantoin, Oryza Sativa (Rice) Bran Extract





Section 51945-4

Section 55106-9

Active Ingredient: TITANIUM DIOXIDE


Structured Label Content

Description (34089-3)

Directions:

When you use or do leisure, apply reasonable amount on your body exposed to UV including face, neck, arms, and legs at your finishing step of basic makeup.

Take more frequent reapplication for longtime outdoor activities.



Notice for use:

1. Discontinue if the following symptom appears and consult with dermatologist for the continuos problem of use.

  1) Discontinue use if redness, rash, irritation or tingling appears.

  2) Discontinue if the above symptom appears by a direct sunlight on the applied part.

2. Avoid the part for a cut, eczema or dermatitis.

3. Please note for keeping and handling.

  1) To keep the freshness, please close the lid after the use.

  2) Keep this and all drugs out of reach of children.

  3) Do not store this product in a place of high or low temperature. Do not expose it to the direct sunlight.

  4) Be careful, it may be slipper when contact with the product.

  5) Be careful not to make contacts with clothes.

  6) Be careful not to give a shock since the container may be broken and get injured.

  7) UV cutoff rating and SPF rating A of this product was measured in accordance with UV cutoff rating effect and methods examined by Korea Food and Drug Administration.

Section 51727-6 (51727-6)

Inactive Ingredients:

Water, Cyclopentasiloxane, Ethylhexyl Methoxycinnamate, Cetyl Ethylhexanoate, Cyclomethicone, Dipropylene Glycol, 4-Methylbenzylidene Camphor, PEG-9 Polydimethylsiloxyethyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Sorbitan Sesquioleate, Disteardimonium Hectorite, Benzophenone-3, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol,

Glyceryl Behenate/Eicosadioate, Sodium Chloride, PEG-10 Dimethicone, Phenoxyethanol, Dimethicone Crosspolymer, Stearic Acid, Aluminum Hydroxide, Fragrance,

Butylparaben, Tocopheryl Acetate, Oryza Sativa (Rice) Bran Oil, Cellulose Gum, Ethylparaben, Methylparaben, Allantoin, Oryza Sativa (Rice) Bran Extract





Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active Ingredient: TITANIUM DIOXIDE


Advanced Ingredient Data


Raw Label Data

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