SUPER BB INSTAREADY BEAUTY BALM BB CREAM- 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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SUPER BB INSTAREADY BEAUTY BALM BB CREAM 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31645-187
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.96 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
LAURETH-12 (UNII: OAH19558U1)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
SHEA BUTTER (UNII: K49155WL9Y)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M)  
AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
MICA (UNII: V8A1AW0880)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:31645-187-021 in 1 CARTON11/24/201506/01/2020
1NDC:31645-187-0135 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/24/201506/01/2020
Labeler - Physicians Formula Inc (021261805)

Revised: 9/2021
Document Id: cd1425a0-2287-a631-e053-2a95a90a4ade
Set id: 2551217f-45ca-4d6b-e054-00144ff88e88
Version: 4
Effective Time: 20210928
 
Physicians Formula Inc