Label: NO MAKEUP LIPSTICK (ROSE) SPF15- zinc oxide lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 45634-470-52 - 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 20, 2022
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INGREDIENTS AND APPEARANCE
NO MAKEUP LIPSTICK (ROSE) SPF15
zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45634-470 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.315 g in 4.2 g Inactive Ingredients Ingredient Name Strength D&C RED NO. 6 (UNII: 481744AI4O) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PENTYLENE GLYCOL (UNII: 50C1307PZG) D&C RED NO. 33 (UNII: 9DBA0SBB0L) 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) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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 Color pink Score Shape Size Flavor VANILLA Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45634-470-52 24.7 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 04/20/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/20/2022 Labeler - N.V Perricone LLC (054414243) Establishment Name Address ID/FEI Business Operations Dimensional Merchandising Inc (DMI) 076693183 manufacture(45634-470)
