Label: BB CREAM- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 15, 2013

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active Ingredients: Titanium Dioxide 11.4% Purpose: Sunscreen

  • 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

  • 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

  • Directions

    Directions: Simply distribute over the skin for a natural finish

  • Principal Display Panel

    BB Cream

    Box For BB Cream

  • INGREDIENTS AND APPEARANCE
    BB CREAM 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24653-282
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.42 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SOLANUM LYCOPERSICUM (UNII: 0243Q4990L)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    SORBIC ACID (UNII: X045WJ989B)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24653-282-021 in 1 CARTON
    1NDC:24653-282-0130 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2013
    Labeler - Janssen Cosmetics GmbH (499187946)
    Registrant - Janssen Cosmetics GmbH (499187946)
    Establishment
    NameAddressID/FEIBusiness Operations
    Janssen Cosmetics GmbH499187946manufacture(24653-282)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Sacher341926681api manufacture(24653-282)