Label: CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 RED/RED- octinoxate lipstick
CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 APPLE/RED- octinoxate lipstick
CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 ROSE/RED- octinoxate lipstick
CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 FUCSIA/RED- octinoxate lipstick
CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 GRAPE/RED- octinoxate lipstick
CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 CHOCOLATE/BROWN- octinoxate lipstick
CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 MARSALA/RED- octinoxate lipstick
CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 ROSE NUDE/RED- octinoxate lipstick

  • Contains inactivated NDC Code(s)
    NDC Code(s):     43596-0064-1, 43596-0064-2, 43596-0065-1, 43596-0065-2, view more
    43596-0066-1, 43596-0066-2, 43596-0067-1, 43596-0067-2, 43596-0068-1, 43596-0068-2, 43596-0069-1, 43596-0069-2, 43596-0070-1, 43596-0070-2, 43596-0071-1, 43596-0071-2
  • 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 24, 2017

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    OCTINOXATE 7.5%

  • 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

    RICINUS COMMUNIS (CASTOR) SEED OIL, OCTYLDODECANOL, POLYETHYLENE, BUTYROSPERMUM PARKII (SHEA) BUTTER, SYNTHETIC BEESWAX, COPERNICIA CERIFERA (CARNAUBA) WAX, DISTEARDIMONIUM HECTORITE, VITIS VINIFERA (GRAPE) SEED OIL, PROPYLENE CARBONATE, SILICA DIMETHYL SILYLATE, TOCOPHERYL ACETATE, PHENOXYETHANOL, FRAGRANCE, METHYLPROPANEDIOL, CAPRYLYL GLYCOL, SILANEDIOL SALICYLATE, CHLORPHENESIN, TROMETHAMINE, CERAMIDE 3, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, HEXYL CINNAMAL. MAY CONTAIN: TITANIUM DIOXIDE, RED 21 LAKE, RED 30 LAKE, IRON OXIDES, YELLOW 5 LAKE, RED 27 LAKE, RED 7 LAKE, TALC, BLUE 1 LAKE.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Red/Red

    cy°

    HYDRAFULL
    Labial     hidratante full color FPS 15

    Net Wt. 0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Red/Red
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Apple/Red

    cy°

    HYDRAFULL
    Labial     hidratante full color FPS 15

    Net Wt. 0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Apple/Red
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rose/Red

    cy°

    HYDRAFULL
    Labial     hidratante full color FPS 15

    Net Wt. 0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rose/Red
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Fucsia/Red

    cy°

    HYDRAFULL
    Labial     hidratante full color FPS 15

    Net Wt. 0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Fucsia/Red
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Grape/Red

    cy°

    HYDRAFULL
    Labial     hidratante full color FPS 15

    Net Wt. 0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Grape/Red
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Chocolate/Brown

    cy°

    HYDRAFULL
    Labial     hidratante full color FPS 15

    Net Wt. 0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Chocolate/Brown
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Marsala/Red

    cy°

    HYDRAFULL
    Labial     hidratante full color FPS 15

    Net Wt. 0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Marsala/Red
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rose Nude/Red

    cy°

    HYDRAFULL
    Labial     hidratante full color FPS 15

    Net Wt. 0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rose Nude/Red
  • INGREDIENTS AND APPEARANCE
    CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15   RED/RED
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0064
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0064-21 in 1 BOX08/24/2017
    1NDC:43596-0064-14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/24/2017
    CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15   APPLE/RED
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0065
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0065-21 in 1 BOX08/24/2017
    1NDC:43596-0065-14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/24/2017
    CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15   ROSE/RED
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0066
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0066-21 in 1 BOX08/24/2017
    1NDC:43596-0066-14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/24/2017
    CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15   FUCSIA/RED
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0067
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0067-21 in 1 BOX08/24/2017
    1NDC:43596-0067-14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/24/2017
    CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15   GRAPE/RED
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0068
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0068-21 in 1 BOX08/24/2017
    1NDC:43596-0068-14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/24/2017
    CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15   CHOCOLATE/BROWN
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0069
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0069-21 in 1 BOX08/24/2017
    1NDC:43596-0069-14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/24/2017
    CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15   MARSALA/RED
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0070-21 in 1 BOX08/24/2017
    1NDC:43596-0070-14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/24/2017
    CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15   ROSE NUDE/RED
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0071
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0071-21 in 1 BOX08/24/2017
    1NDC:43596-0071-14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/24/2017
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(43596-0064, 43596-0065, 43596-0066, 43596-0067, 43596-0068, 43596-0069, 43596-0070, 43596-0071)
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