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Dosage form: cream
Ingredients: OCTINOXATE 7.5g in 100g, TITANIUM DIOXIDE 2.2g in 100g, ENZACAMENE 2.0g in 100g
Labeler: Cleansia Co Ltd
NDC Code: 45167-516

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, Benzophenone-3

Inactive Ingredients:
Water, Cyclopentasiloxane, Disteardimonium Hectorite, Dimethiconol, Tocopheryl Acetate, PEG-10 Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Sorbitan Sesquioleate, Glyceryl Behenate/Eicosadioate, Cetyl Ethylhexanoate, Cyclohexasiloxane, Propylene Glycol, Dipropylene Glycol, Allantoin, Aluminum Hydroxide, Stearic Acid, Xanthan Gum, Methylparaben, Sodium Chloride, Butylparaben, Imidazolidinyl Urea, Fragrance, Ethylparaben, Oryza Sativa (Rice) bran Oil, Oryza Sativa (Rice) Bran Extract

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 long time outdoor activities

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:45167-516
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
#Item CodePackage Description
1NDC:45167-516-16100 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.