Label: LBEL DIVINE LIP GLOSS SPF 15 (PECHE) - BROWN- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS SPF 15 (GRAPE LUMIERE) - MAGENTA- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS SPF 15 (SWEET FRAMBOISE) - PINK- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS SPF 15 (DOUCE) - PINK- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS SPF 15 (VIN) - BROWN- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS SPF 15 (CARAMEL MELON) - BROWN- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS SPF 15 (GROSEILLE) - BROWN- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS SPF 15 (VIN SENSUELLE) - RED- octinoxate and oxybenzone lipstick

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    13537-467-01, 13537-467-02, 13537-468-03, 13537-468-04, view more
    13537-469-05, 13537-469-06, 13537-470-07, 13537-470-08, 13537-471-09, 13537-471-10, 13537-472-11, 13537-472-12, 13537-473-13, 13537-473-14, 13537-474-15, 13537-474-16
  • Packager: Ventura Corporation LTD
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 29, 2014

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Octinoxate 7.5%Sunscreen
    Oxybenzone 3%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

    Hydrogenated polyisobutene, diisopropyl dimer dilinoleate, isostearyl neopentanoate, beeswax, silica dimethyl silylate, fragrance, glycerin, prunus amygdalus dulcis (sweet almond) oil, tocopheryl acetate, cocos nucifera (coconut) oil, aloe barbadensis leaf extract, hydrogenated vegetable oil, propylparaben, methylparaben, sodium saccharin, bht, citrus limon (lemon) peel wax, citrus limon (lemon) peel oil, citrus aurantium dulcis (orange) peel oil, citrus aurantium dulcis (orange) peel wax.

    May contain: mica , red 7 lake , titanium dioxide, iron oxides, yellow 5 lake , red 40 lake, blue 1 lake, carmine, talc, palmitic acid.

  • SPL UNCLASSIFIED SECTION

    P.R.: Dist. by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

  • PRINCIPAL DISPLAY PANEL - 12 ml Tube Carton - (PECHE) - BROWN

    DIVINE LIP GLOSS
    Lip gloss SPF 15

    12 ml e (.40 fl.oz.)
    L'BEL

    Principal Display Panel - 12 ml Tube Carton - (PECHE) - BROWN
  • PRINCIPAL DISPLAY PANEL - 12 ml Tube Carton - (GRAPE LUMIERE) - MAGENTA

    DIVINE LIP GLOSS
    Lip gloss SPF 15

    12 ml e (.40 fl.oz.)
    L'BEL

    Principal Display Panel - 12 ml Tube Carton - (GRAPE LUMIERE) - MAGENTA
  • PRINCIPAL DISPLAY PANEL - 12 ml Tube Carton - (SWEET FRAMBOISE) - PINK

    DIVINE LIP GLOSS
    Lip gloss SPF 15

    12 ml e (.40 fl.oz.)
    L'BEL

    Principal Display Panel - 12 ml Tube Carton - (SWEET FRAMBOISE) - PINK
  • PRINCIPAL DISPLAY PANEL - 12 ml Tube Carton - (DOUCE) - PINK

    DIVINE LIP GLOSS
    Lip gloss SPF 15

    12 ml e (.40 fl.oz.)
    L'BEL

    Principal Display Panel - 12 ml Tube Carton - (DOUCE) - PINK
  • PRINCIPAL DISPLAY PANEL - 12 ml Tube Carton - (VIN) - BROWN

    DIVINE LIP GLOSS
    Lip gloss SPF 15

    12 ml e (.40 fl.oz.)
    L'BEL

    Principal Display Panel - 12 ml Tube Carton - (VIN) - BROWN
  • PRINCIPAL DISPLAY PANEL - 12 ml Tube Carton - (CARAMEL MELON) - BROWN

    DIVINE LIP GLOSS
    Lip gloss SPF 15

    12 ml e (.40 fl.oz.)
    L'BEL

    Principal Display Panel - 12 ml Tube Carton - (CARAMEL MELON) - BROWN
  • PRINCIPAL DISPLAY PANEL - 12 ml Tube Carton - (GROSEILLE) - BROWN

    DIVINE LIP GLOSS
    Lip gloss SPF 15

    12 ml e (.40 fl.oz.)
    L'BEL

    Principal Display Panel - 12 ml Tube Carton - (GROSEILLE) - BROWN
  • PRINCIPAL DISPLAY PANEL - 12 ml Tube Carton - (VIN SENSUELLE) - RED

    DIVINE LIP GLOSS
    Lip gloss SPF 15

    12 ml e (.40 fl.oz.)
    L'BEL

    Principal Display Panel - 12 ml Tube Carton - (VIN SENSUELLE) - RED
  • INGREDIENTS AND APPEARANCE
    LBEL DIVINE LIP GLOSS SPF 15   (PECHE) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-467
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.03 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEMON PEEL WAX (UNII: 20G0UPO0TI)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TALC (UNII: 7SEV7J4R1U)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-467-021 in 1 BOX
    1NDC:13537-467-0112 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL DIVINE LIP GLOSS SPF 15   (GRAPE LUMIERE) - MAGENTA
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-468
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.03 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEMON PEEL WAX (UNII: 20G0UPO0TI)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TALC (UNII: 7SEV7J4R1U)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-468-041 in 1 BOX
    1NDC:13537-468-0312 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL DIVINE LIP GLOSS SPF 15   (SWEET FRAMBOISE) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-469
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.03 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEMON PEEL WAX (UNII: 20G0UPO0TI)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TALC (UNII: 7SEV7J4R1U)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-469-061 in 1 BOX
    1NDC:13537-469-0512 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL DIVINE LIP GLOSS SPF 15   (DOUCE) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-470
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.03 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEMON PEEL WAX (UNII: 20G0UPO0TI)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TALC (UNII: 7SEV7J4R1U)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-470-081 in 1 BOX
    1NDC:13537-470-0712 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL DIVINE LIP GLOSS SPF 15   (VIN) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-471
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.03 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEMON PEEL WAX (UNII: 20G0UPO0TI)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TALC (UNII: 7SEV7J4R1U)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-471-101 in 1 BOX
    1NDC:13537-471-0912 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL DIVINE LIP GLOSS SPF 15   (CARAMEL MELON) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-472
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.03 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEMON PEEL WAX (UNII: 20G0UPO0TI)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TALC (UNII: 7SEV7J4R1U)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-472-121 in 1 BOX
    1NDC:13537-472-1112 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL DIVINE LIP GLOSS SPF 15   (GROSEILLE) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-473
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.03 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEMON PEEL WAX (UNII: 20G0UPO0TI)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TALC (UNII: 7SEV7J4R1U)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-473-141 in 1 BOX
    1NDC:13537-473-1312 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL DIVINE LIP GLOSS SPF 15   (VIN SENSUELLE) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-474
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.03 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEMON PEEL WAX (UNII: 20G0UPO0TI)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TALC (UNII: 7SEV7J4R1U)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-474-161 in 1 BOX
    1NDC:13537-474-1512 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-467, 13537-468, 13537-469, 13537-470, 13537-471, 13537-472, 13537-473, 13537-474)