Label: LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 ROUGE AMORE/RED- octinoxate and zinc oxide lipstick
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 ROUGE CORAIL/RED- octinoxate and zinc oxide lipstick
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 ROUGE/RED- octinoxate and zinc oxide lipstick
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 FRAMBOISE/RED- octinoxate and zinc oxide lipstick
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 FUCSIA ROYAL/RED- octinoxate and zinc oxide lipstick
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 ROSE NUDE/RED- octinoxate and zinc oxide lipstick
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 FUCSIA RADIANT/RED- octinoxate and zinc oxide lipstick
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 SALMON/RED- octinoxate and zinc oxide lipstick
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 FUCSIA/RED- octinoxate and zinc oxide lipstick
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 BURDEOS/RED- octinoxate and zinc oxide lipstick
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 CARAMEL TOASTED/BROWN- octinoxate and zinc oxide lipstick
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 MALVA NUDE/RED- octinoxate and zinc oxide lipstick
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NDC Code(s):
14783-158-01,
14783-158-02,
14783-159-01,
14783-159-02, view more14783-161-01, 14783-161-02, 14783-162-01, 14783-162-02, 14783-163-01, 14783-163-02, 14783-164-01, 14783-164-02, 14783-165-01, 14783-165-02, 14783-166-01, 14783-166-02, 14783-167-01, 14783-167-02, 14783-168-01, 14783-168-02, 14783-169-01, 14783-169-02, 14783-178-01, 14783-178-02
- Packager: Ventura International LTD
- 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 November 16, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- Warnings
- Directions
- Other information
-
Inactive ingredients
DIISOPROPYL DIMER DILINOLEATE, ISONONYL ISONONANOATE, OZOKERITE, DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, POLYGLYCERYL-3 DIISOSTEARATE, TRIDECYL TRIMELLITATE, POLYMETHYLSILSESQUIOXANE, POLYETHYLENE, COPERNICIA CERIFERA (CARNAUBA) WAX, HYDROGENATED POLYCYCLOPENTADIENE, PTFE, BUTYROSPERMUM PARKII (SHEA) BUTTER, TRIDECYL STEARATE, ISODODECANE, SILICA DIMETHYL SILYLATE, TOCOPHERYL ACETATE, MICA, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PHENOXYETHANOL, CETEARYL ETHYLHEXANOATE, METHYLPROPANEDIOL, COCOS NUCIFERA (COCONUT) OIL, ALOE BARBADENSIS LEAF EXTRACT, FRAGRANCE, CERAMIDE 3, CAPRYLYL GLYCOL, SILANEDIOL SALICYLATE, CHLORPHENESIN, TRIETHOXYCAPRYLYLSILANE, TROMETHAMINE, SORBITAN ISOSTEARATE, DIMETHICONE, LIMONIUM GERBERI EXTRACT, GRIFOLA FRONDOSA FRUITING BODY EXTRACT, MALTODEXTRIN, PORTULACA PILOSA EXTRACT, TRIMETHYLSILOXYSILICATE, SUCROSE COCOATE, PALMITOYL TRIPEPTIDE-38, BENZYL BENZOATE, AMYL CINNAMAL, HEXYL CINNAMAL, LINALOOL. MAY CONTAIN : TITANIUM DIOXIDE, IRON OXIDES, RED 27 LAKE, RED 21 LAKE, RED 7 LAKE, YELLOW 5 LAKE, RED 30 LAKE, TALC, BLUE 1 LAKE.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - ROUGE AMORE/Red
- PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - ROUGE CORAIL/Red
- PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - ROUGE/Red
- PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - FRAMBOISE/Red
- PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - FUCSIA ROYAL/Red
- PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - ROSE NUDE/Red
- PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - FUCSIA RADIANT/Red
- PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - SALMON/Red
- PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - FUCSIA/Red
- PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - BURDEOS/Red
- PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - CARAMEL TOASTED/Brown
- PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - MALVA NUDE/Red
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INGREDIENTS AND APPEARANCE
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20Â ROUGE AMORE/RED
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-158 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 g  in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.0392 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  ISODODECANE (UNII: A8289P68Y2)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  MICA (UNII: V8A1AW0880)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  METHYLPROPANEDIOL (UNII: N8F53B3R4R)  COCONUT OIL (UNII: Q9L0O73W7L)  ALOE VERA LEAF (UNII: ZY81Z83H0X)  CERAMIDE NP (UNII: 4370DF050B)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  SILANEDIOL SALICYLATE (UNII: C054DF30K0)  CHLORPHENESIN (UNII: I670DAL4SZ)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  TROMETHAMINE (UNII: 023C2WHX2V)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  DIMETHICONE (UNII: 92RU3N3Y1O)  MALTODEXTRIN (UNII: 7CVR7L4A2D)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  BENZYL BENZOATE (UNII: N863NB338G)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-158-02 1 in 1 BOX 10/19/2018 11/16/2020 1 NDC:14783-158-01 3.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/19/2018 11/16/2020 LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  ROUGE CORAIL/RED
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-159 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 g  in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.0392 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  ISODODECANE (UNII: A8289P68Y2)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  MICA (UNII: V8A1AW0880)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  METHYLPROPANEDIOL (UNII: N8F53B3R4R)  COCONUT OIL (UNII: Q9L0O73W7L)  ALOE VERA LEAF (UNII: ZY81Z83H0X)  CERAMIDE NP (UNII: 4370DF050B)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  SILANEDIOL SALICYLATE (UNII: C054DF30K0)  CHLORPHENESIN (UNII: I670DAL4SZ)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  TROMETHAMINE (UNII: 023C2WHX2V)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  DIMETHICONE (UNII: 92RU3N3Y1O)  MALTODEXTRIN (UNII: 7CVR7L4A2D)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  BENZYL BENZOATE (UNII: N863NB338G)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-159-02 1 in 1 BOX 10/19/2018 1 NDC:14783-159-01 3.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/19/2018 LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  ROUGE/RED
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-178 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 g  in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.0392 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  ISODODECANE (UNII: A8289P68Y2)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  MICA (UNII: V8A1AW0880)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  METHYLPROPANEDIOL (UNII: N8F53B3R4R)  COCONUT OIL (UNII: Q9L0O73W7L)  ALOE VERA LEAF (UNII: ZY81Z83H0X)  CERAMIDE NP (UNII: 4370DF050B)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  SILANEDIOL SALICYLATE (UNII: C054DF30K0)  CHLORPHENESIN (UNII: I670DAL4SZ)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  TROMETHAMINE (UNII: 023C2WHX2V)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  DIMETHICONE (UNII: 92RU3N3Y1O)  MALTODEXTRIN (UNII: 7CVR7L4A2D)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  BENZYL BENZOATE (UNII: N863NB338G)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-178-02 1 in 1 BOX 10/19/2018 1 NDC:14783-178-01 3.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/19/2018 LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 FRAMBOISE/RED
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-161 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 g  in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.0392 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  ISODODECANE (UNII: A8289P68Y2)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  MICA (UNII: V8A1AW0880)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  METHYLPROPANEDIOL (UNII: N8F53B3R4R)  COCONUT OIL (UNII: Q9L0O73W7L)  ALOE VERA LEAF (UNII: ZY81Z83H0X)  CERAMIDE NP (UNII: 4370DF050B)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  SILANEDIOL SALICYLATE (UNII: C054DF30K0)  CHLORPHENESIN (UNII: I670DAL4SZ)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  TROMETHAMINE (UNII: 023C2WHX2V)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  DIMETHICONE (UNII: 92RU3N3Y1O)  MALTODEXTRIN (UNII: 7CVR7L4A2D)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  BENZYL BENZOATE (UNII: N863NB338G)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-161-02 1 in 1 BOX 10/19/2018 11/16/2020 1 NDC:14783-161-01 3.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/19/2018 11/16/2020 LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 FUCSIA ROYAL/RED
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-162 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 g  in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.0392 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  ISODODECANE (UNII: A8289P68Y2)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  MICA (UNII: V8A1AW0880)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  METHYLPROPANEDIOL (UNII: N8F53B3R4R)  COCONUT OIL (UNII: Q9L0O73W7L)  ALOE VERA LEAF (UNII: ZY81Z83H0X)  CERAMIDE NP (UNII: 4370DF050B)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  SILANEDIOL SALICYLATE (UNII: C054DF30K0)  CHLORPHENESIN (UNII: I670DAL4SZ)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  TROMETHAMINE (UNII: 023C2WHX2V)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  DIMETHICONE (UNII: 92RU3N3Y1O)  MALTODEXTRIN (UNII: 7CVR7L4A2D)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  BENZYL BENZOATE (UNII: N863NB338G)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-162-02 1 in 1 BOX 10/19/2018 11/16/2020 1 NDC:14783-162-01 3.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/19/2018 11/16/2020 LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  ROSE NUDE/RED
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-163 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 g  in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.0392 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  ISODODECANE (UNII: A8289P68Y2)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  MICA (UNII: V8A1AW0880)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  METHYLPROPANEDIOL (UNII: N8F53B3R4R)  COCONUT OIL (UNII: Q9L0O73W7L)  ALOE VERA LEAF (UNII: ZY81Z83H0X)  CERAMIDE NP (UNII: 4370DF050B)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  SILANEDIOL SALICYLATE (UNII: C054DF30K0)  CHLORPHENESIN (UNII: I670DAL4SZ)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  TROMETHAMINE (UNII: 023C2WHX2V)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  DIMETHICONE (UNII: 92RU3N3Y1O)  MALTODEXTRIN (UNII: 7CVR7L4A2D)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  BENZYL BENZOATE (UNII: N863NB338G)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-163-02 1 in 1 BOX 10/19/2018 1 NDC:14783-163-01 3.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/19/2018 LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 FUCSIA RADIANT/RED
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-164 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 g  in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.0392 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  ISODODECANE (UNII: A8289P68Y2)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  MICA (UNII: V8A1AW0880)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  METHYLPROPANEDIOL (UNII: N8F53B3R4R)  COCONUT OIL (UNII: Q9L0O73W7L)  ALOE VERA LEAF (UNII: ZY81Z83H0X)  CERAMIDE NP (UNII: 4370DF050B)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  SILANEDIOL SALICYLATE (UNII: C054DF30K0)  CHLORPHENESIN (UNII: I670DAL4SZ)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  TROMETHAMINE (UNII: 023C2WHX2V)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  DIMETHICONE (UNII: 92RU3N3Y1O)  MALTODEXTRIN (UNII: 7CVR7L4A2D)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  BENZYL BENZOATE (UNII: N863NB338G)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-164-02 1 in 1 BOX 10/19/2018 11/16/2020 1 NDC:14783-164-01 3.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/19/2018 11/16/2020 LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 SALMON/RED
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-165 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 g  in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.0392 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  ISODODECANE (UNII: A8289P68Y2)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  MICA (UNII: V8A1AW0880)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  METHYLPROPANEDIOL (UNII: N8F53B3R4R)  COCONUT OIL (UNII: Q9L0O73W7L)  ALOE VERA LEAF (UNII: ZY81Z83H0X)  CERAMIDE NP (UNII: 4370DF050B)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  SILANEDIOL SALICYLATE (UNII: C054DF30K0)  CHLORPHENESIN (UNII: I670DAL4SZ)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  TROMETHAMINE (UNII: 023C2WHX2V)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  DIMETHICONE (UNII: 92RU3N3Y1O)  MALTODEXTRIN (UNII: 7CVR7L4A2D)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  BENZYL BENZOATE (UNII: N863NB338G)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-165-02 1 in 1 BOX 10/19/2018 11/16/2020 1 NDC:14783-165-01 3.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/19/2018 11/16/2020 LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  FUCSIA/RED
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-166 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 g  in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.0392 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  ISODODECANE (UNII: A8289P68Y2)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  MICA (UNII: V8A1AW0880)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  METHYLPROPANEDIOL (UNII: N8F53B3R4R)  COCONUT OIL (UNII: Q9L0O73W7L)  ALOE VERA LEAF (UNII: ZY81Z83H0X)  CERAMIDE NP (UNII: 4370DF050B)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  SILANEDIOL SALICYLATE (UNII: C054DF30K0)  CHLORPHENESIN (UNII: I670DAL4SZ)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  TROMETHAMINE (UNII: 023C2WHX2V)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  DIMETHICONE (UNII: 92RU3N3Y1O)  MALTODEXTRIN (UNII: 7CVR7L4A2D)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  BENZYL BENZOATE (UNII: N863NB338G)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-166-02 1 in 1 BOX 10/19/2018 1 NDC:14783-166-01 3.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/19/2018 LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  BURDEOS/RED
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-167 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 g  in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.0392 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  ISODODECANE (UNII: A8289P68Y2)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  MICA (UNII: V8A1AW0880)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  METHYLPROPANEDIOL (UNII: N8F53B3R4R)  COCONUT OIL (UNII: Q9L0O73W7L)  ALOE VERA LEAF (UNII: ZY81Z83H0X)  CERAMIDE NP (UNII: 4370DF050B)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  SILANEDIOL SALICYLATE (UNII: C054DF30K0)  CHLORPHENESIN (UNII: I670DAL4SZ)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  TROMETHAMINE (UNII: 023C2WHX2V)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  DIMETHICONE (UNII: 92RU3N3Y1O)  MALTODEXTRIN (UNII: 7CVR7L4A2D)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  BENZYL BENZOATE (UNII: N863NB338G)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-167-02 1 in 1 BOX 10/19/2018 1 NDC:14783-167-01 3.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/19/2018 LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 CARAMEL TOASTED/BROWN
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-168 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 g  in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.0392 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  ISODODECANE (UNII: A8289P68Y2)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  MICA (UNII: V8A1AW0880)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  METHYLPROPANEDIOL (UNII: N8F53B3R4R)  COCONUT OIL (UNII: Q9L0O73W7L)  ALOE VERA LEAF (UNII: ZY81Z83H0X)  CERAMIDE NP (UNII: 4370DF050B)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  SILANEDIOL SALICYLATE (UNII: C054DF30K0)  CHLORPHENESIN (UNII: I670DAL4SZ)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  TROMETHAMINE (UNII: 023C2WHX2V)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  DIMETHICONE (UNII: 92RU3N3Y1O)  MALTODEXTRIN (UNII: 7CVR7L4A2D)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  BENZYL BENZOATE (UNII: N863NB338G)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-168-02 1 in 1 BOX 10/19/2018 11/16/2020 1 NDC:14783-168-01 3.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/19/2018 11/16/2020 LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 MALVA NUDE/RED
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-169 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 g  in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.0392 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  ISODODECANE (UNII: A8289P68Y2)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  MICA (UNII: V8A1AW0880)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  METHYLPROPANEDIOL (UNII: N8F53B3R4R)  COCONUT OIL (UNII: Q9L0O73W7L)  ALOE VERA LEAF (UNII: ZY81Z83H0X)  CERAMIDE NP (UNII: 4370DF050B)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  SILANEDIOL SALICYLATE (UNII: C054DF30K0)  CHLORPHENESIN (UNII: I670DAL4SZ)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  TROMETHAMINE (UNII: 023C2WHX2V)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  DIMETHICONE (UNII: 92RU3N3Y1O)  MALTODEXTRIN (UNII: 7CVR7L4A2D)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  BENZYL BENZOATE (UNII: N863NB338G)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-169-02 1 in 1 BOX 10/19/2018 11/16/2020 1 NDC:14783-169-01 3.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/19/2018 11/16/2020 Labeler - Ventura International LTD (603192787) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 manufacture(14783-158, 14783-159, 14783-178, 14783-161, 14783-162, 14783-163, 14783-164, 14783-165, 14783-166, 14783-167, 14783-168, 14783-169)
