SUPER BB 10-IN-1 BEAUTY BALM CREAM SPF 30- titanium dioxide, zinc oxide cream 
PHYSICIANS FORMULA INC

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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DRUG FACTS

Warning: For external use only. When using this product, keep out of eyes. rinse with water to remove.

Active Ingredients: Titanium Dioxide 5.76% Zinc Oxide 2.94%

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

image of carton

SUPER BB 10-IN-1 BEAUTY BALM CREAM  SPF 30
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31645-164
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.76 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
SHEA BUTTER (UNII: K49155WL9Y)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LAURETH-12 (UNII: OAH19558U1)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
MICA (UNII: V8A1AW0880)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:31645-164-021 in 1 BOX
1NDC:31645-164-0135 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/05/2013
Labeler - PHYSICIANS FORMULA INC (021261805)
Establishment
NameAddressID/FEIBusiness Operations
PHYSICIANS FORMULA INC825048945manufacture(31645-164)

Revised: 12/2012
Document Id: 0b08e5f6-7ced-440c-8d3f-c4c79f498f58
Set id: e271a9ff-7453-4241-a965-ac540f530729
Version: 2
Effective Time: 20121219
 
PHYSICIANS FORMULA INC