NO MAKEUP LIPSTICK (COGNAC) 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 (COGNAC) SPF15 
zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45634-467
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.1764 g  in 4.2 g
Inactive Ingredients
Ingredient NameStrength
SYNTHETIC WAX (2900 MW) (UNII: U5UP035C8A)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ACRYLIC ACID/2-ETHYLHEXYL ACRYLATE/STYRENE COPOLYMER (500000 MW) (UNII: 3K8D4YRM4R)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
D&C RED NO. 6 (UNII: 481744AI4O)  
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)  
BIS-PEG-10 DIMETHICONE/DIMER DILINOLEATE COPOLYMER (UNII: CF5W1YCX11)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)  
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)  
VANILLIN (UNII: CHI530446X)  
CERESIN (UNII: Q1LS2UJO3A)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)  
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
Colorbrown (deep reddish brown) Score    
ShapeSize
FlavorVANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45634-467-5224.7 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product04/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/14/2022
Labeler - N.V Perricone LLC (054414243)
Establishment
NameAddressID/FEIBusiness Operations
Dimensional Merchandising Inc (DMI)076693183manufacture(45634-467)

Revised: 4/2022
Document Id: dc9f9ec9-548c-75d8-e053-2a95a90a2d3e
Set id: dc9f9ec9-548b-75d8-e053-2a95a90a2d3e
Version: 1
Effective Time: 20220414
 
N.V Perricone LLC