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 
Ventura Corporation LTD

----------

L'BEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM

Drug Facts

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, notskin cancer or early skin aging.
  • For external use only.

  • Do not useon damaged or broken skin.

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

  • Stop use and ask a doctor ifrash 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

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
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 BOX12/22/201512/31/2021
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 DrugM02012/22/201512/31/2021
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 BOX12/22/201512/31/2021
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 DrugM02012/22/201512/31/2021
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
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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-706-021 in 1 BOX12/22/201512/31/2021
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 DrugM02012/22/201512/31/2021
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 BOX12/22/201512/31/2021
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 DrugM02012/22/201512/31/2021
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 BOX12/22/201512/31/2021
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 DrugM02012/22/201512/31/2021
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 BOX12/22/201512/31/2021
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 DrugM02012/22/201512/31/2021
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 BOX12/22/201512/31/2021
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 DrugM02012/22/201512/31/2021
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 BOX12/22/201512/31/2021
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 DrugM02012/22/201512/31/2021
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(13537-706, 13537-707, 13537-708, 13537-709, 13537-710, 13537-711, 13537-704, 13537-705)

Revised: 3/2025
 
Ventura Corporation LTD