Label: NWC 21 NATURAL PREMIUM BB CREAM- octinoxate, titanium dioxide, enzacamene cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated January 21, 2010

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  • ACTIVE INGREDIENT

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

    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
  • WHEN USING

    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.
  • DO NOT USE

    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 OUT OF REACH OF CHILDREN

    Keep this and all drugs out of reach of children
  • PRECAUTIONS

    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
  • STORAGE AND HANDLING

    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
  • PRINCIPAL DISPLAY PANEL

    BOX LABEL
  • INGREDIENTS AND APPEARANCE
    NWC 21 NATURAL PREMIUM BB CREAM 
    octinoxate, titanium dioxide, enzacamene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45167-451
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 g  in 50 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.1 g  in 50 g
    ENZACAMENE (UNII: 8I3XWY40L9) (ENZACAMENE - UNII:8I3XWY40L9) ENZACAMENE1.0 g  in 50 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cleansia Co Ltd687655956manufacture
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