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 
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 SPF 15

Drug Facts

Active IngredientsPurpose
Octinoxate 7.5%Sunscreen
Oxybenzone 3%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, 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.

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
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)

Revised: 1/2014
Document Id: 2156c7d0-09a6-4f68-84b7-a2442b799fd9
Set id: 752eabd7-44e1-4ac0-8531-dfe897332d57
Version: 1
Effective Time: 20140129
 
Ventura Corporation LTD