Label: BB CREAM- titanium dioxide cream
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Contains inactivated NDC Code(s)
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
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
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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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INGREDIENTS AND APPEARANCE
BB CREAM
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24653-282 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.42 g in 30 mL Inactive Ingredients Ingredient Name Strength 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 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)