SPF 30 CONCEALER- spf 30 concealer cream 
Vrea LLC.

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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Active Ingredient

Purpose and Uses

Warnings

Warnings and Precautions

inactive Ingredients

Outer Carton

Package Label Principal Display Panel

Principal Display Panel

PDP

SPF 30 CONCEALER 
spf 30 concealer cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81854-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9.3154 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.108665 g  in 100 g
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) 3.1 g  in 100 g
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) 2.0705 g  in 100 g
METHYL METHACRYLATE (UNII: 196OC77688) 1.67 g  in 100 g
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) 0.21 g  in 100 g
BORON NITRIDE (UNII: 2U4T60A6YD) 0.185 g  in 100 g
STEARYL TRIETHOXYSILANE (UNII: 1VN9P25L8H) 0.2499 g  in 100 g
DUNALIELLA SALINA (UNII: F4O1DKI9A6) 0.0309 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 12.40115 g  in 100 g
ISODODECANE (UNII: A8289P68Y2) 7.893 g  in 100 g
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) 0.9288 g  in 100 g
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) 0.606 g  in 100 g
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) 0.2973 g  in 100 g
ETHYL FERULATE (UNII: 5B8915UELW) 0.2973 g  in 100 g
HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9) 0.062 g  in 100 g
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO) 0.005665 g  in 100 g
PANTOLACTONE, (+/-)- (UNII: IID733HD2M) 0.005665 g  in 100 g
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) 0.003 g  in 100 g
DIMETHICONE 100 (UNII: RO266O364U) 2.0295 g  in 100 g
LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 2.01 g  in 100 g
MICA (UNII: V8A1AW0880) 1.665 g  in 100 g
PROPYLENE CARBONATE (UNII: 8D08K3S51E) 0.258 g  in 100 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.005665 g  in 100 g
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.005665 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 4.117 g  in 100 g
PROPANEDIOL (UNII: 5965N8W85T) 1.29 g  in 100 g
SODIUM CHLORIDE (UNII: 451W47IQ8X) 1.26 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9579 g  in 100 g
PANTHENOL (UNII: WV9CM0O67Z) 0.3605 g  in 100 g
WATER (UNII: 059QF0KO0R) 18.795145 g  in 100 g
Product Characteristics
Colorbrown (Medium Neutral) , brown (Light) , brown (Deep Honey) , brown (Light Neutral) , brown (Rich Neutral) , brown (Fair Neutral) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81854-001-011 in 1 CARTON06/01/2021
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2021
Labeler - Vrea LLC. (057455597)
Registrant - Vrea LLC. (057455597)
Establishment
NameAddressID/FEIBusiness Operations
New Look Cosmetics080801719manufacture(81854-001)

Revised: 1/2023
Document Id: f1e26887-0147-6355-e053-2a95a90ae452
Set id: c061769c-c19e-2626-e053-2995a90a934b
Version: 3
Effective Time: 20230109
 
Vrea LLC.