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

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.

----------

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

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

Other information

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 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)

Revised: 1/2016
Document Id: ec6e8395-a148-4675-9c45-fc7ec42e0cfe
Set id: e9a32538-4938-4aec-9def-0eabe3b61cc1
Version: 1
Effective Time: 20160114
 
Ventura Corporation LTD