Label: HARD CANDY CORRECTION CREME- octinoxate, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58875-101-01 - Packager: Xtreme Color Inc.
- Category: HUMAN OTC DRUG LABEL
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 August 27, 2013
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INGREDIENTS AND APPEARANCE
HARD CANDY CORRECTION CREME
octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58875-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 2.55 g in 42.5 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.7 g in 42.5 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) 5.15525 g in 42.5 g HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) 2.55425 g in 42.5 g CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) 1.27925 g in 42.5 g FERROSOFERRIC OXIDE (UNII: XM0M87F357) 1.1333 g in 42.5 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 0.189 g in 42.5 g FERRIC OXIDE RED (UNII: 1K09F3G675) 1.1333 g in 42.5 g FERRIC OXIDE YELLOW (UNII: EX438O2MRT) 1.1333 g in 42.5 g SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) 0.0425 g in 42.5 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 1.0115 g in 42.5 g POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 0.85 g in 42.5 g TRIBEHENIN (UNII: 8OC9U7TQZ0) 2.89425 g in 42.5 g CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) 2.171113 g in 42.5 g DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) 0.255425 g in 42.5 g PROPYLENE CARBONATE (UNII: 8D08K3S51E) 0.127713 g in 42.5 g .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.0425 g in 42.5 g PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.17595 g in 42.5 g SORBIC ACID (UNII: X045WJ989B) 0.02125 g in 42.5 g CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.1428 g in 42.5 g ISODODECANE (UNII: A8289P68Y2) 1.70425 g in 42.5 g WATER (UNII: 059QF0KO0R) 13.68625 g in 42.5 g GLYCERIN (UNII: PDC6A3C0OX) 1.27925 g in 42.5 g SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.425 g in 42.5 g MICA (UNII: V8A1AW0880) 0.195 g in 42.5 g CHROMIC OXIDE (UNII: X5Z09SU859) .006 g in 42.5 g FERRIC FERROCYANIDE (UNII: TLE294X33A) .001 g in 42.5 g CARMINIC ACID (UNII: CID8Z8N95N) .003 g in 42.5 g SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) 0.425 g in 42.5 g STEARETH-2 (UNII: V56DFE46J5) 0.2125 g in 42.5 g Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58875-101-01 42.5 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/12/2013 Labeler - Xtreme Color Inc. (628045858) Establishment Name Address ID/FEI Business Operations NuWorld Corporation 628045858 manufacture(58875-101) , pack(58875-101) , label(58875-101)
