BB CREAM- titanium dioxide cream

BB Cream by

Drug Labeling and Warnings

BB Cream by is a Otc medication manufactured, distributed, or labeled by Janssen Cosmetics GmbH, Dr. Sacher. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BB CREAM 
titanium dioxide cream

Product 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)