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Dosage form: cream
Ingredients: TITANIUM DIOXIDE 2.10mL in 60mL
NDC Code: 45167-040

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.

Drug Facts

Active Ingredient: TITANIUM DIOXIDE

Inactive Ingredients:
Water, Cyclopentasiloxane, Ethylhexyl Methoxycinnamate, C12-15 Alkyl Benzoate, Ethylhexyl Salicylate, Butylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine,
Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Beeswax, Disteardimonium Hectorite, Glycerin, Sodium Chloride, Aluminum Stearate, Dimethicone Crosspolymer, Cetearyl Alcohol, Polyhydroxystearic Acid, Microcrystalline Wax, Phenoxyethanol, Alumina, Methylparaben, Propylparaben, Xanthan Gum, Dipotassium Glycyrrhizate, Polyglutamic Acid, Oryza Sativa (Rice) Bran Extract, Fragrance

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.

titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45167-040
Route of AdministrationCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
#Item CodePackage Description
1NDC:45167-040-0160 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2009
Labeler - CLEANSIA CORPORATION LTD. (687655956)

Revised: 09/2010

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.