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Name:Nwc21 Natural Sun Protectorspf35
Manufacturer:Cleansia Corporation Ltd.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

NWC21 NATURAL SUN PROTECTOR SPF35 - titanium dioxide cream 
CLEANSIA CORPORATION LTD.

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.

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Drug Facts

Active Ingredient: TITANIUM DIOXIDE

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


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.

Image of carton


NWC21 NATURAL SUN PROTECTOR  SPF35
titanium dioxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:45167-030
Route of Administration CUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE 1.18 mL  in 60 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45167-030-01 60 mL in 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 04/01/2009

Labeler - CLEANSIA CORPORATION LTD. (687655956)

Revised: 09/2010 CLEANSIA CORPORATION LTD.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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