Label: LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM PECHE - BROWN- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM SWEET FRAMBOISE - PINK- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM DOUCE - PINK- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM VIN - BROWN- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM GRAPE LUMIERE - PINK- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM CARAMEL MELON - BROWN- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM GROSEILLE - BROWN- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM VIN SENSUELLE - RED- octinoxate and oxybenzone lipstick

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    13537-704-01, 13537-704-02, 13537-705-01, 13537-705-02, view more
    13537-706-01, 13537-706-02, 13537-707-01, 13537-707-02, 13537-708-01, 13537-708-02, 13537-709-01, 13537-709-02, 13537-710-01, 13537-710-02, 13537-711-01, 13537-711-02
  • 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 January 14, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    OCTINOXATE 7.50 %,Sunscreen
    OXYBENZONE 3.00 %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, SYNTHETIC BEESWAX, SILICA DIMETHYL SILYLATE, PARFUM (FRAGRANCE), PHENOXYETHANOL, GLYCERIN, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL), TOCOPHERYL ACETATE, COCOS NUCIFERA (COCONUT) OIL, ALOE BARBADENSIS LEAF EXTRACT, HYDROGENATED VEGETABLE OIL, SODIUM SACCHARIN, CAPRYLYL GLYCOL, CHLORPHENESIN, BHT, CITRUS LIMON (LEMON) PEEL WAX, CITRUS LIMON (LEMON) PEEL OIL, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, CITRUS AURANTIUM DULCIS (ORANGE) PEEL WAX, d-LIMONENE, BENZYL ALCOHOL, BENZYL SALICYLATE, HEXYL CINNAMAL, METHYL 2-OCTYNOATE, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, CINNAMAL.

    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

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

  • PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - PECHE - BROWN

    DIVINE LIP GLOSS
    Lip gloss
    SPF 15 FM

    12 ml e (0.40 fl.oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - PECHE - BROWN
  • PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - SWEET FRAMBOISE - PINK

    DIVINE LIP GLOSS
    Lip gloss
    SPF 15 FM

    12 ml e (0.40 fl.oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - SWEET FRAMBOISE - PINK
  • PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - DOUCE - PINK

    DIVINE LIP GLOSS
    Lip gloss
    SPF 15 FM

    12 ml e (0.40 fl.oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - DOUCE - PINK
  • PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - VIN - BROWN

    DIVINE LIP GLOSS
    Lip gloss
    SPF 15 FM

    12 ml e (0.40 fl.oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - VIN - BROWN
  • PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - GRAPE LUMIERE - PINK

    DIVINE LIP GLOSS
    Lip gloss
    SPF 15 FM

    12 ml e (0.40 fl.oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - GRAPE LUMIERE - PINK
  • PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - CARAMEL MELON - BROWN

    DIVINE LIP GLOSS
    Lip gloss
    SPF 15 FM

    12 ml e (0.40 fl.oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - CARAMEL MELON - BROWN
  • PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - GROSEILLE - BROWN

    DIVINE LIP GLOSS
    Lip gloss
    SPF 15 FM

    12 ml e (0.40 fl.oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - GROSEILLE - BROWN
  • PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - VIN SENSUELLE - RED

    DIVINE LIP GLOSS
    Lip gloss
    SPF 15 FM

    12 ml e (0.40 fl.oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - VIN SENSUELLE - RED
  • INGREDIENTS AND APPEARANCE
    LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM   PECHE - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-704
    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)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEMON PEEL WAX (UNII: 20G0UPO0TI)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    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:13537-704-021 in 1 BOX
    1NDC:13537-704-0112 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/22/2015
    LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM   SWEET FRAMBOISE - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-705
    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)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEMON PEEL WAX (UNII: 20G0UPO0TI)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    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:13537-705-021 in 1 BOX
    1NDC:13537-705-0112 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/22/2015
    LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM   DOUCE - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-706
    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)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEMON PEEL WAX (UNII: 20G0UPO0TI)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    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:13537-706-021 in 1 BOX
    1NDC:13537-706-0112 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/22/2015
    LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM   VIN - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-707
    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)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEMON PEEL WAX (UNII: 20G0UPO0TI)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    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:13537-707-021 in 1 BOX
    1NDC:13537-707-0112 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/22/2015
    LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM   GRAPE LUMIERE - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-708
    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)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEMON PEEL WAX (UNII: 20G0UPO0TI)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    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:13537-708-021 in 1 BOX
    1NDC:13537-708-0112 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/22/2015
    LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM   CARAMEL MELON - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-709
    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)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEMON PEEL WAX (UNII: 20G0UPO0TI)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    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:13537-709-021 in 1 BOX
    1NDC:13537-709-0112 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/22/2015
    LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM   GROSEILLE - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-710
    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)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEMON PEEL WAX (UNII: 20G0UPO0TI)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    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:13537-710-021 in 1 BOX
    1NDC:13537-710-0112 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/22/2015
    LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM   VIN SENSUELLE - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-711
    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)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEMON PEEL WAX (UNII: 20G0UPO0TI)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    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:13537-711-021 in 1 BOX
    1NDC:13537-711-0112 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/22/2015
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-704, 13537-705, 13537-706, 13537-707, 13537-708, 13537-709, 13537-710, 13537-711)