Label: ELEVEN UNRIVALED SERUM- zinc oxide lotion
- NDC Code(s): 79163-399-01, 79163-399-02, 79163-399-03
- Packager: Eco Chic, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 March 7, 2023
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- ELEVEN UNRIVALED SERUM
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INGREDIENTS AND APPEARANCE
ELEVEN UNRIVALED SERUM
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79163-399 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 110 mg in 1 mL Inactive Ingredients Ingredient Name Strength PHENYLPROPANOL (UNII: 0F897O3O4M) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHYLPROPANEDIOL (UNII: N8F53B3R4R) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) ALLANTOIN (UNII: 344S277G0Z) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) VANILLA PLANIFOLIA WHOLE (UNII: BOS0R5Y21O) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) COCOS NUCIFERA WHOLE (UNII: 245J88W96L) HEDYCHIUM SPICATUM WHOLE (UNII: V88105URGI) SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG) PROPANEDIOL (UNII: 5965N8W85T) CITRUS NOBILIS (UNII: 8MFF77J91V) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) COCONUT ALKANES (UNII: 1E5KJY107T) RUTIN (UNII: 5G06TVY3R7) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TOCOPHEROL (UNII: R0ZB2556P8) CAPRYLYL GLYCOL (UNII: 00YIU5438U) COCO-CAPRYLATE (UNII: 4828G836N6) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79163-399-02 1 in 1 CARTON 11/01/2022 1 NDC:79163-399-01 28 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:79163-399-03 8 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2022 Labeler - Eco Chic, LLC (097807096) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(79163-399) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 api manufacture(79163-399) , manufacture(79163-399) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 118812921 manufacture(79163-399) , pack(79163-399)
