QT SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, ENZACAMENE) CREAM [CLEANSIA CO LTD]

QT SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, ENZACAMENE) CREAM [CLEANSIA CO LTD]
PDF | XML

NDC 45167-516-16
Set ID 80e07a95-6249-49b2-8610-c430b9fcd5b4
Category HUMAN OTC DRUG LABEL
Packager Cleansia Co Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

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

    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 USING

    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 long time outdoor activities
  • 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
    QT SUN BLOCK 
    octinoxate, titanium dioxide, enzacamene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45167-516
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.2 g  in 100 g
    ENZACAMENE (UNII: 8I3XWY40L9) (ENZACAMENE - UNII:8I3XWY40L9) ENZACAMENE2.0 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cleansia Co Ltd687655956manufacture

Related Drugs