Label: BB CREAM- titanium dioxide cream

  • NDC Code(s): 24653-282-01, 24653-282-02
  • Packager: Janssen Cosmetics GmbH
  • 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 01/13

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  • Drug Facts

    Active Ingredients: Titanium Dioxide 11.4% Purpose: Sunscreen

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  • Ingredients

    Ingredients: small-capssmall-capsWater, Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Glycerin Octyldodecyl Stearoyl Stearate, Diisoproply Sebacate, Cetearyl Alcohol, Glyceryl Sterate, Silica, Polyhydroxystearic Acid, Potassium Palmitoyl Hydrolyzed Wheat Protein, CI 77 492 [Iron Oxides],Butyrospermum Parkii Butter, Benzyl Alcohol, Microcrystalline Cellulose, Cetyl Alcohol, Alumina, Stearic Acid, Tocopherol, Citric Acid, Hydrolyzed Beta Maritima Extract, CI 77 491 [Iron Oxides], Solanmum Lycopersicum Seed Oil, [Solanmum Lycopersicum (Tomato) Seed Oil], Xanthan Gum Lavandula Angustifolia Oil, Helianthus Annuus Seed Oil , [Helianthus Annuus (Sunflower) Seed Oil, Cellulose Gum, CI 77 499 [Iron Oxides], Dehydroacetic Acid, Vaccinium Macrocarpon Seed Oil[Vaccinium Macrocarpon (Cranberry) Seed Oil] , Cellulose, Sorbic Acid, Sodium Hydroxide

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  • Warning

    For External use only. Not to be sallowed. Avoid contact with the eyes. If contact occurs rinse eyes. Discontinue use if signs of irritation or rash appear. If irriation or rash persists, consult a doctor

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  • Directions

    Directions: Simply distribute over the skin for a natural finish

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  • Principal Display Panel

    BB Cream

    Box For BB Cream

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  • INGREDIENTS AND APPEARANCE
    BB CREAM 
    titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:24653-282
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 3.42 g  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALOE VERA LEAF  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE  
    GLYCERIN  
    DIISOPROPYL SEBACATE  
    CETOSTEARYL ALCOHOL  
    GLYCERYL STEARATE CITRATE  
    SILICON DIOXIDE  
    POLYHYDROXYSTEARIC ACID (2300 MW)  
    FERRIC OXIDE YELLOW  
    SHEA BUTTER  
    BENZYL ALCOHOL  
    CELLULOSE, MICROCRYSTALLINE  
    CETYL ALCOHOL  
    ALUMINUM OXIDE  
    STEARIC ACID  
    TOCOPHEROL  
    CITRIC ACID ACETATE  
    FERRIC OXIDE RED  
    SOLANUM LYCOPERSICUM  
    XANTHAN GUM  
    LAVENDER OIL  
    SUNFLOWER OIL  
    CARBOXYMETHYLCELLULOSE SODIUM  
    FERROSOFERRIC OXIDE  
    DEHYDROACETIC ACID  
    CRANBERRY SEED OIL  
    POWDERED CELLULOSE  
    SORBIC ACID  
    SODIUM HYDROXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24653-282-02 1 in 1 CARTON
    1 NDC:24653-282-01 30 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 01/01/2013
    Labeler - Janssen Cosmetics GmbH (499187946)
    Registrant - Janssen Cosmetics GmbH (499187946)
    Establishment
    Name Address ID/FEI Business Operations
    Janssen Cosmetics GmbH 499187946 manufacture(24653-282)
    Establishment
    Name Address ID/FEI Business Operations
    Dr. Sacher 341926681 api manufacture(24653-282)
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