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Dosage form: cream
Ingredients: OCTINOXATE 3.75g in 50g, TITANIUM DIOXIDE 1.1g in 50g, ENZACAMENE 1.0g in 50g
Labeler: Cleansia Co Ltd
NDC Code: 45167-451

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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

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.

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

Keep this and all drugs out of reach of children

- 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

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

octinoxate, titanium dioxide, enzacamene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45167-451
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
#Item CodePackage Description
1NDC:45167-451-6750 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/21/2010
Labeler - Cleansia Co Ltd (687655956)
Registrant - Cleansia Co Ltd (687655956)
Cleansia Co Ltd687655956manufacture

Revised: 01/2010
Cleansia Co Ltd

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.