Label: FIKIA MARINE NATURAL SUN BB SPF 50 PA- titanium dioxide 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 October 25, 2014

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  • ACTIVE INGREDIENT

    titanium dioxide


  • INACTIVE INGREDIENT

    water, glycerin, zinc oxide, dimethicone, porphyra tenera ext, butylene glycol, arbutin, sodium chloride, iron dioxide, etc


  • PURPOSE

    whitening
    anti-wrinkle
    sun block


  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children


  • INDICATIONS & USAGE

    apply evenly after daily skin-care routine


  • WARNINGS

    -If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
    -This product is for exeternal use only. Do not use for internal use
    -If possible, avoid direct sunlight and store in cool and area of low humidity
    -In order to maintain the quality of the product and avoid misuse
    -Avoid placing the product near fire and store out in reach of children


  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    FIKIA MARINE NATURAL SUN BB SPF 50 PA 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69327-4001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69327-4001-130 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/25/2014
    Labeler - Beauty Line Co., Ltd. (688528938)
    Registrant - Beauty Line Co., Ltd. (688528938)
    Establishment
    NameAddressID/FEIBusiness Operations
    C-Max Korea Co, Ltd.688295460manufacture(69327-4001)
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