SPL v1
SPL
SPL Set ID 2deda89e-c641-4b08-a70e-f8e7d68a28a2
Route
TOPICAL
Published
Effective Date 2010-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.75 g) Titanium Dioxide (1.1 g) Enzacamene (1.0 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-01-21

Description

Active Ingredients: Ethylhexyl Methoxycinnamate, Titanium Dioxide, 4-Methylbenzylidene Camphor, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Arbutin, Benzophenone-3, Adenosine


Medication Information

Description

Active Ingredients: Ethylhexyl Methoxycinnamate, Titanium Dioxide, 4-Methylbenzylidene Camphor, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Arbutin, Benzophenone-3, Adenosine

Section 42232-9
Caution:

- Be careful it may be slippery when contact with the product

- Be careful not to make contact with clothes

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

Section 44425-7
Storage and Handling:

- To keep the freshness, please close the lid after the use

- Do not store this product in a place of high or low temperature

- Do not expose it to the direct sunlight

Section 50565-1
Keep this and all drugs out of reach of children

Section 50567-7
Directions:

Slightly apply reasonable amount on your forehead, nose, cheeks and jaw at your finishing step of basic make up and keep patting to make it absorbed.  You will have a close adhesion feeling if you apply after the basic makeup has been completely absorbed.  It is not required to use additional make up base or foundation.  If you want complete skin cover, apply small amount on targeted skin part and keep patting to make a natural cover.

Section 50570-1
Notice for Use:

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

a) Discontinue use if redness, rash, irritation or tingling appears

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

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

Section 51727-6
Inactive Ingredients:

Water, Dimethicone, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipropylene Glycol, Dimethicone/PEG-10/15 Crosspolymer, Glycerin, Propylene glycol, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, Phytosteryl Macadamiate, PEG-10 Dimethicone, Silica dimethyl silylate, Betaine, Methylparaben, Oryza Sativa (Rice) bran Oil, Silica, Mica, Dipotassium Glycyrrhizate, Sodium Citrate, Oryza sativa (Rice) Bran extract, Propylparaben, Sodium Chloride, Iron Oxides, Ultramarines, Sorbitan Olivate, Tocopheryl Acetate, Xanthan Gum, Fragrance, Hydrogenated lecithin, Morus Alba Root Extract, ceramide-3
Section 51945-4
Section 55106-9
Active Ingredients:

Ethylhexyl Methoxycinnamate, Titanium Dioxide, 4-Methylbenzylidene Camphor, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Arbutin, Benzophenone-3, Adenosine


Structured Label Content

Section 42232-9 (42232-9)
Caution:

- Be careful it may be slippery when contact with the product

- Be careful not to make contact with clothes

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

Section 44425-7 (44425-7)
Storage and Handling:

- To keep the freshness, please close the lid after the use

- Do not store this product in a place of high or low temperature

- Do not expose it to the direct sunlight

Section 50565-1 (50565-1)
Keep this and all drugs out of reach of children

Section 50567-7 (50567-7)
Directions:

Slightly apply reasonable amount on your forehead, nose, cheeks and jaw at your finishing step of basic make up and keep patting to make it absorbed.  You will have a close adhesion feeling if you apply after the basic makeup has been completely absorbed.  It is not required to use additional make up base or foundation.  If you want complete skin cover, apply small amount on targeted skin part and keep patting to make a natural cover.

Section 50570-1 (50570-1)
Notice for Use:

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

a) Discontinue use if redness, rash, irritation or tingling appears

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

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

Section 51727-6 (51727-6)
Inactive Ingredients:

Water, Dimethicone, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipropylene Glycol, Dimethicone/PEG-10/15 Crosspolymer, Glycerin, Propylene glycol, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, Phytosteryl Macadamiate, PEG-10 Dimethicone, Silica dimethyl silylate, Betaine, Methylparaben, Oryza Sativa (Rice) bran Oil, Silica, Mica, Dipotassium Glycyrrhizate, Sodium Citrate, Oryza sativa (Rice) Bran extract, Propylparaben, Sodium Chloride, Iron Oxides, Ultramarines, Sorbitan Olivate, Tocopheryl Acetate, Xanthan Gum, Fragrance, Hydrogenated lecithin, Morus Alba Root Extract, ceramide-3
Section 51945-4 (51945-4)
Section 55106-9 (55106-9)
Active Ingredients:

Ethylhexyl Methoxycinnamate, Titanium Dioxide, 4-Methylbenzylidene Camphor, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Arbutin, Benzophenone-3, Adenosine


Advanced Ingredient Data


Raw Label Data

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