INSTAREADY FULL COVERAGE CONCEALER 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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PDP

PDP

INSTAREADY FULL COVERAGE CONCEALER  SPF 30
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31645-198
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.95 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.92 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
LAUROYL LYSINE (UNII: 113171Q70B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE 100 (UNII: RO266O364U)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
DECYL ISOSTEARATE (UNII: NRB038QC02)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:31645-198-021 in 1 CARTON11/15/201606/01/2020
1NDC:31645-198-0110.5 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/201606/01/2020
Labeler - Physicians Formula, Inc. (021261805)
Registrant - Markwins International Corp. (113313969)

Revised: 10/2020
Document Id: b2e9cf0d-0b65-0e5d-e053-2a95a90a7874
Set id: 403236d1-4bad-671a-e054-00144ff88e88
Version: 2
Effective Time: 20201030
 
Physicians Formula, Inc.