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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:24653-282
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE3.42 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 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)

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