Label: ERBORIAN BB CREME AU GINSENG DORE - titanium dioxide, octinoxate and zinc oxide cream

  • NDC Code(s): 68021-1002-1, 68021-1002-2
  • Packager: Kolmar Korea Co Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/10

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  • Drug Facts

    Active Ingredient

    Titanium Dioxide                            6.39%
    Octinoxate                                    3.00%
    Zinc Oxide                                    1.92%

    Uses
    Helps prevent sunburn. Provides High protect from sunburn. Higher SPF gives more sunburn protection.

    Directions
    Apply after basic skin care product. Spread and appropriate amount entire face following the skin texture. Reapply as required.

    Warnings
    For external use only.
    UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.
    When using the product Keep out of eyes. Rinse with water to remove.

    Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center

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  • Erborian BB Crème Au Ginseng Doré

    SYMBIOSE COSMETICS


    Net WT. 1.5 OZ (45mL)

    image of carton label


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  • INGREDIENTS AND APPEARANCE
    ERBORIAN BB CREME AU GINSENG DORE 
    titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68021-1002
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 6.39 mL  in 100 mL
    OCTINOXATE (OCTINOXATE) OCTINOXATE 3.00 mL  in 100 mL
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 1.92 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CYCLOMETHICONE 5  
    GLYCERIN  
    TALC  
    DIPROPYLENE GLYCOL  
    DIMETHICONE  
    FERRIC OXIDE YELLOW  
    BETAINE  
    HEXYL LAURATE  
    MAGNESIUM SULFATE, UNSPECIFIED  
    PHENOXYETHANOL  
    FERRIC OXIDE RED  
    PALMITIC ACID  
    ALUMINUM HYDROXIDE  
    .ALPHA.-TOCOPHEROL ACETATE, D-  
    FERROSOFERRIC OXIDE  
    BUTYLENE GLYCOL  
    ETHYLHEXYLGLYCERIN  
    LINALOOL, DL-  
    .BETA.-CITRONELLOL, R-(+)-  
    GERANIOL  
    EUGENOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68021-1002-2 1 in 1 BOX
    1 NDC:68021-1002-1 45 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 10/08/2010
    Labeler - Kolmar Korea Co Ltd (687846360)
    Registrant - Kolmar Korea Co Ltd (687846360)
    Establishment
    Name Address ID/FEI Business Operations
    Kolmar Korea Co Ltd 687846360 manufacture
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