NO MAKEUP LIPSTICK (BERRY) SPF15- zinc oxide lipstick 
N.V Perricone 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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NO MAKEUP LIPSTICK (BERRY) SPF15 
zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45634-469
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.315 g  in 4.2 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
FD&C YELLOW NO. 5 ALUMINUM LAKE (UNII: JQ6BLH9FR7)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
FERROUS OXIDE (UNII: G7036X8B5H)  
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
BIS-PEG-10 DIMETHICONE/DIMER DILINOLEATE COPOLYMER (UNII: CF5W1YCX11)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)  
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)  
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR)  
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)  
VANILLIN (UNII: CHI530446X)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)  
CERESIN (UNII: Q1LS2UJO3A)  
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorVANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45634-469-5224.7 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product04/20/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/20/2022
Labeler - N.V Perricone LLC (054414243)
Establishment
NameAddressID/FEIBusiness Operations
Dimensional Merchandising Inc (DMI)076693183manufacture(45634-469)

Revised: 4/2022
Document Id: dd16f024-1fde-53b8-e053-2995a90a0be3
Set id: dd16ef73-62e9-4d27-e053-2995a90ab41c
Version: 1
Effective Time: 20220420
 
N.V Perricone LLC