BB CREAM- titanium dioxide cream 
Janssen Cosmetics GmbH

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.

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BB Cream

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

BB CREAM 
titanium dioxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24653-282
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 1/2013
Document Id: 03f16424-f02a-4ab7-8a1d-f5e9fb0fc870
Set id: b7476d4f-1d72-4ca3-b42d-b6b012cbdec3
Version: 1
Effective Time: 20130115
 
Janssen Cosmetics GmbH