Label: ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD PIMIENTA CALIENTE) - BROWN- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD VINO CAUTIVANTE) - BROWN- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSA VIVA) - PINK- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CORAL ENSUENO) - RED- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROJO GLAM) - RED- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CAFE HABANO) - BROWN- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FUCSIA VIBRANTE) - PINK- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MELON INTENSE) - PINK- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSADO CHIC) - PINK- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CIRUELA GLAM) - RED- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FRAMBUESA ENCANTO) - PURPLE- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MAGENTA SWEET) - PURPLE- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20- octinoxate kit

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    13537-577-01, 13537-577-02, 13537-578-03, 13537-578-04, view more
    13537-579-05, 13537-579-06, 13537-580-07, 13537-580-08, 13537-581-09, 13537-581-10, 13537-582-11, 13537-582-12, 13537-583-13, 13537-583-14, 13537-584-15, 13537-584-16, 13537-585-17, 13537-585-18, 13537-586-19, 13537-586-20, 13537-587-21, 13537-587-22, 13537-588-23, 13537-588-24, 13537-589-27, 13537-589-28
  • Packager: Ventura Corporation 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 August 25, 2015

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Octinoxate 6.8 %

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
  • Warnings

    • Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    • For external use only.

    • Do not use on damaged or broken skin.

    • When using this product keep out of eyes. Rinse with water to remove.

    • Stop use and ask a doctor if rash occurs.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Apply liberally and evenly 15 minutes before sun exposure.
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: Ask a doctor
  • Other information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    DIISOPROPYL DIMER DILINOLEATE, OCTYLDODECANOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYETHYLENE, TRIDECYL TRIMELLITATE, CASTOR ISOSTEARATE BEESWAX SUCCINATE, POLYGLYCERYL-3 DIISOSTEARATE, ISOPROPYL LANOLATE, COPERNICIA CERIFERA (CARNAUBA) WAX, MICA, MICROCRYSTALLINE WAX, DIISOSTEARYL MALATE, GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, PHENOXYETHANOL, BETA-SITOSTEROL, PHENYL TRIMETHICONE, SILICA, SILICA SILYLATE, EUPHORBIA CERIFERA (CANDELILLA) WAX, FRAGRANCE, CAPRYLYL GLYCOL, DIMETHICONE, CHLORPHENESIN, CERAMIDE 3, TOCOPHERYL ACETATE, OLEYL ALCOHOL, TRIMETHYLSILOXYSILICATE, BENZIMIDAZOLE DIAMOND AMIDOETHYL UREA CARBAMOYL PROPYL POLYMETHYLSILSESQUIOXANE, DIOLEYL TOCOPHERYL METHYLSILANOL. May Contain: TITANIUM DIOXIDE, MICA, IRON OXIDES, RED 30 LAKE, RED 7 LAKE, YELLOW 5 LAKE, RED 27 LAKE, TALC, CALCIUM ALUMINUM BOROSILICATE, CARMINE, TIN OXIDE.

  • SPL UNCLASSIFIED SECTION

    Dist by Ventura Corp, Ltd., San Juan, Puerto Rico 00926.

  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD PIMIENTA CALIENTE) - BROWN

    HD COLOR
    High Definition Color
    LIPSTICK SPF 20

    Net Weight 0.14 oz e (4 g)

    ésika
    PRO

    Principal Display Panel - 4 g Tube Box (HD PIMIENTA CALIENTE) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD VINO CAUTIVANTE) - BROWN

    HD COLOR
    High Definition Color
    LIPSTICK SPF 20

    Net Weight 0.14 oz e (4 g)

    ésika
    PRO

    Principal Display Panel - 4 g Tube Box (HD VINO CAUTIVANTE) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD ROSA VIVA) - PINK

    HD COLOR
    High Definition Color
    LIPSTICK SPF 20

    Net Weight 0.14 oz e (4 g)

    ésika
    PRO

    Principal Display Panel - 4 g Tube Box (HD ROSA VIVA) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD CORAL ENSUENO) - RED

    HD COLOR
    High Definition Color
    LIPSTICK SPF 20

    Net Weight 0.14 oz e (4 g)

    ésika
    PRO

    Principal Display Panel - 4 g Tube Box (HD CORAL ENSUENO) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD ROJO GLAM) - RED

    HD COLOR
    High Definition Color
    LIPSTICK SPF 20

    Net Weight 0.14 oz e (4 g)

    ésika
    PRO

    Principal Display Panel - 4 g Tube Box (HD ROJO GLAM) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD CAFE HABANO) - BROWN

    HD COLOR
    High Definition Color
    LIPSTICK SPF 20

    Net Weight 0.14 oz e (4 g)

    ésika
    PRO

    Principal Display Panel - 4 g Tube Box (HD CAFE HABANO) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD FUCSIA VIBRANTE) - PINK

    HD COLOR
    High Definition Color
    LIPSTICK SPF 20

    Net Weight 0.14 oz e (4 g)

    ésika
    PRO

    Principal Display Panel - 4 g Tube Box (HD FUCSIA VIBRANTE) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD MELON INTENSE) - PINK

    HD COLOR
    High Definition Color
    LIPSTICK SPF 20

    Net Weight 0.14 oz e (4 g)

    ésika
    PRO

    Principal Display Panel - 4 g Tube Box (HD MELON INTENSE) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD ROSADO CHIC) - PINK

    HD COLOR
    High Definition Color
    LIPSTICK SPF 20

    Net Weight 0.14 oz e (4 g)

    ésika
    PRO

    Principal Display Panel - 4 g Tube Box (HD ROSADO CHIC) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD CIRUELA GLAM) - RED

    HD COLOR
    High Definition Color
    LIPSTICK SPF 20

    Net Weight 0.14 oz e (4 g)

    ésika
    PRO

    Principal Display Panel - 4 g Tube Box (HD CIRUELA GLAM) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD FRAMBUESA ENCANTO) - PURPLE

    HD COLOR
    High Definition Color
    LIPSTICK SPF 20

    Net Weight 0.14 oz e (4 g)

    ésika
    PRO

    Principal Display Panel - 4 g Tube Box (HD FRAMBUESA ENCANTO) - PURPLE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD MAGENTA SWEET) - PURPLE

    HD COLOR
    High Definition Color
    LIPSTICK SPF 20

    Net Weight 0.14 oz e (4 g)

    ésika
    PRO

    Principal Display Panel - 4 g Tube Box (HD MAGENTA SWEET) - PURPLE
  • PRINCIPAL DISPLAY PANEL - Kit Carton

    HD COLOR
    HIGH DEFINITION COLOR LIPSTICK
    SPF 20

    ésika
    PRO

    Net Weight
    0.275 oz. e (7.8 g)

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD PIMIENTA CALIENTE) - BROWN
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-577
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-577-021 in 1 BOX
    1NDC:13537-577-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD VINO CAUTIVANTE) - BROWN
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-578
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-578-041 in 1 BOX
    1NDC:13537-578-034 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD ROSA VIVA) - PINK
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-579
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-579-061 in 1 BOX
    1NDC:13537-579-054 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD CORAL ENSUENO) - RED
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-580
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-580-081 in 1 BOX
    1NDC:13537-580-074 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD ROJO GLAM) - RED
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-581
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-581-101 in 1 BOX
    1NDC:13537-581-094 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD CAFE HABANO) - BROWN
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-582
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-582-121 in 1 BOX
    1NDC:13537-582-114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD FUCSIA VIBRANTE) - PINK
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-583
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-583-141 in 1 BOX
    1NDC:13537-583-134 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD MELON INTENSE) - PINK
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-584
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-584-161 in 1 BOX
    1NDC:13537-584-154 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD ROSADO CHIC) - PINK
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-585
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-585-181 in 1 BOX
    1NDC:13537-585-174 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD CIRUELA GLAM) - RED
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-586
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-586-201 in 1 BOX
    1NDC:13537-586-194 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD FRAMBUESA ENCANTO) - PURPLE
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-587
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-587-221 in 1 BOX
    1NDC:13537-587-214 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD MAGENTA SWEET) - PURPLE
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-588
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-588-241 in 1 BOX
    1NDC:13537-588-234 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  
    octinoxate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-589
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-589-282 in 1 BOX
    1NDC:13537-589-271 in 1 TUBE
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 4 g
    Part 21 TUBE 4 g
    Part 31 TUBE 4 g
    Part 41 TUBE 4 g
    Part 51 TUBE 4 g
    Part 61 TUBE 4 g
    Part 71 TUBE 4 g
    Part 81 TUBE 4 g
    Part 91 TUBE 4 g
    Part 101 TUBE 4 g
    Part 111 TUBE 4 g
    Part 121 TUBE 4 g
    Part 1 of 12
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD PIMIENTA CALIENTE) - BROWN
    octinoxate lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    Part 2 of 12
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD VINO CAUTIVANTE) - BROWN
    octinoxate lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    Part 3 of 12
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD ROSA VIVA) - PINK
    octinoxate lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    Part 4 of 12
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD CORAL ENSUENO) - RED
    octinoxate lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    Part 5 of 12
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD ROJO GLAM) - RED
    octinoxate lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    Part 6 of 12
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD CAFE HABANO) - BROWN
    octinoxate lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    Part 7 of 12
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD FUCSIA VIBRANTE) - PINK
    octinoxate lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    Part 8 of 12
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD MELON INTENSE) - PINK
    octinoxate lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    Part 9 of 12
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD ROSADO CHIC) - PINK
    octinoxate lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    Part 10 of 12
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD CIRUELA GLAM) - RED
    octinoxate lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    Part 11 of 12
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD FRAMBUESA ENCANTO) - PURPLE
    octinoxate lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    Part 12 of 12
    ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD MAGENTA SWEET) - PURPLE
    octinoxate lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    D&C RED No. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/17/2015
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-577, 13537-578, 13537-579, 13537-580, 13537-581, 13537-582, 13537-583, 13537-584, 13537-585, 13537-586, 13537-587, 13537-588, 13537-589)