Label: NO MAKEUP LIPSTICK (COGNAC) SPF15- zinc oxide lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 45634-467-52 - Packager: N.V Perricone LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 14, 2022
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INGREDIENTS AND APPEARANCE
NO MAKEUP LIPSTICK (COGNAC) SPF15
zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45634-467 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.1764 g in 4.2 g Inactive Ingredients Ingredient Name Strength 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 Color brown (deep reddish brown) Score Shape Size Flavor VANILLA Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45634-467-52 24.7 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 04/14/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/14/2022 Labeler - N.V Perricone LLC (054414243) Establishment Name Address ID/FEI Business Operations Dimensional Merchandising Inc (DMI) 076693183 manufacture(45634-467)
