LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 ROUGE AMORE/RED- octinoxate and zinc oxide lipstick 
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 ROUGE CORAIL/RED- octinoxate and zinc oxide lipstick 
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 ROUGE/RED- octinoxate and zinc oxide lipstick 
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 FRAMBOISE/RED- octinoxate and zinc oxide lipstick 
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 FUCSIA ROYAL/RED- octinoxate and zinc oxide lipstick 
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 ROSE NUDE/RED- octinoxate and zinc oxide lipstick 
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 FUCSIA RADIANT/RED- octinoxate and zinc oxide lipstick 
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 SALMON/RED- octinoxate and zinc oxide lipstick 
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 FUCSIA/RED- octinoxate and zinc oxide lipstick 
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 BURDEOS/RED- octinoxate and zinc oxide lipstick 
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 CARAMEL TOASTED/BROWN- octinoxate and zinc oxide 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 CONCENTRÉ TOTAL LABIOS LIPSTICK GLOBAL PERFECTION SPF 20

Drug Facts

Active IngredientsPurpose
OCTINOXATE 7.5 %Sunscreen
ZINC OXIDE 3.92 %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

DIISOPROPYL DIMER DILINOLEATE, ISONONYL ISONONANOATE, OZOKERITE, DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, POLYGLYCERYL-3 DIISOSTEARATE, TRIDECYL TRIMELLITATE, POLYMETHYLSILSESQUIOXANE, POLYETHYLENE, COPERNICIA CERIFERA (CARNAUBA) WAX, HYDROGENATED POLYCYCLOPENTADIENE, PTFE, BUTYROSPERMUM PARKII (SHEA) BUTTER, TRIDECYL STEARATE, ISODODECANE, SILICA DIMETHYL SILYLATE, TOCOPHERYL ACETATE, MICA, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PHENOXYETHANOL, CETEARYL ETHYLHEXANOATE, METHYLPROPANEDIOL, COCOS NUCIFERA (COCONUT) OIL, ALOE BARBADENSIS LEAF EXTRACT, FRAGRANCE, CERAMIDE 3, CAPRYLYL GLYCOL, SILANEDIOL SALICYLATE, CHLORPHENESIN, TRIETHOXYCAPRYLYLSILANE, TROMETHAMINE, SORBITAN ISOSTEARATE, DIMETHICONE, LIMONIUM GERBERI EXTRACT, GRIFOLA FRONDOSA FRUITING BODY EXTRACT, MALTODEXTRIN, PORTULACA PILOSA EXTRACT, TRIMETHYLSILOXYSILICATE, SUCROSE COCOATE, PALMITOYL TRIPEPTIDE-38, BENZYL BENZOATE, AMYL CINNAMAL, HEXYL CINNAMAL, LINALOOL. MAY CONTAIN : TITANIUM DIOXIDE, IRON OXIDES, RED 27 LAKE, RED 21 LAKE, RED 7 LAKE, YELLOW 5 LAKE, RED 30 LAKE, TALC, BLUE 1 LAKE.

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

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - ROUGE AMORE/Red

L'BEL

CONCENTRÉ
TOTAL
LABIOS

lipstick
global
perfection SPF 20

Net Wt. 0.11 oz. e (3,4 g)

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - ROUGE AMORE/Red

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - ROUGE CORAIL/Red

L'BEL

CONCENTRÉ
TOTAL
LABIOS

lipstick
global
perfection SPF 20

Net Wt. 0.11 oz. e (3,4 g)

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - ROUGE CORAIL/Red

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - ROUGE/Red

L'BEL

CONCENTRÉ
TOTAL
LABIOS

lipstick
global
perfection SPF 20

Net Wt. 0.11 oz. e (3,4 g)

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - ROUGE/Red

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - FRAMBOISE/Red

L'BEL

CONCENTRÉ
TOTAL
LABIOS

lipstick
global
perfection SPF 20

Net Wt. 0.11 oz. e (3,4 g)

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - FRAMBOISE/Red

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - FUCSIA ROYAL/Red

L'BEL

CONCENTRÉ
TOTAL
LABIOS

lipstick
global
perfection SPF 20

Net Wt. 0.11 oz. e (3,4 g)

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - FUCSIA ROYAL/Red

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - ROSE NUDE/Red

L'BEL

CONCENTRÉ
TOTAL
LABIOS

lipstick
global
perfection SPF 20

Net Wt. 0.11 oz. e (3,4 g)

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - ROSE NUDE/Red

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - FUCSIA RADIANT/Red

L'BEL

CONCENTRÉ
TOTAL
LABIOS

lipstick
global
perfection SPF 20

Net Wt. 0.11 oz. e (3,4 g)

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - FUCSIA RADIANT/Red

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - SALMON/Red

L'BEL

CONCENTRÉ
TOTAL
LABIOS

lipstick
global
perfection SPF 20

Net Wt. 0.11 oz. e (3,4 g)

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - SALMON/Red

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - FUCSIA/Red

L'BEL

CONCENTRÉ
TOTAL
LABIOS

lipstick
global
perfection SPF 20

Net Wt. 0.11 oz. e (3,4 g)

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - FUCSIA/Red

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - BURDEOS/Red

L'BEL

CONCENTRÉ
TOTAL
LABIOS

lipstick
global
perfection SPF 20

Net Wt. 0.11 oz. e (3,4 g)

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - BURDEOS/Red

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - CARAMEL TOASTED/Brown

L'BEL

CONCENTRÉ
TOTAL
LABIOS

lipstick
global
perfection SPF 20

Net Wt. 0.11 oz. e (3,4 g)

PRINCIPAL DISPLAY PANEL - 3.4 g Tube Box - CARAMEL TOASTED/Brown
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  ROUGE AMORE/RED
octinoxate and zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
ISODODECANE (UNII: A8289P68Y2)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
MICA (UNII: V8A1AW0880)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CERAMIDE NP (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TROMETHAMINE (UNII: 023C2WHX2V)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0108-21 in 1 BOX10/19/201811/16/2020
1NDC:43596-0108-13.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/19/201811/16/2020
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  ROUGE CORAIL/RED
octinoxate and zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
ISODODECANE (UNII: A8289P68Y2)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
MICA (UNII: V8A1AW0880)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CERAMIDE NP (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TROMETHAMINE (UNII: 023C2WHX2V)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0109-21 in 1 BOX10/19/201811/16/2020
1NDC:43596-0109-13.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/19/201811/16/2020
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  ROUGE/RED
octinoxate and zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
ISODODECANE (UNII: A8289P68Y2)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
MICA (UNII: V8A1AW0880)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CERAMIDE NP (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TROMETHAMINE (UNII: 023C2WHX2V)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0110-21 in 1 BOX10/19/201811/16/2020
1NDC:43596-0110-13.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/19/201811/16/2020
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  FRAMBOISE/RED
octinoxate and zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
ISODODECANE (UNII: A8289P68Y2)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
MICA (UNII: V8A1AW0880)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CERAMIDE NP (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TROMETHAMINE (UNII: 023C2WHX2V)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0111-21 in 1 BOX10/19/201811/16/2020
1NDC:43596-0111-13.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/19/201811/16/2020
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  FUCSIA ROYAL/RED
octinoxate and zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
ISODODECANE (UNII: A8289P68Y2)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
MICA (UNII: V8A1AW0880)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CERAMIDE NP (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TROMETHAMINE (UNII: 023C2WHX2V)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0112-21 in 1 BOX10/19/201811/16/2020
1NDC:43596-0112-13.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/19/201811/16/2020
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  ROSE NUDE/RED
octinoxate and zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0113
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
ISODODECANE (UNII: A8289P68Y2)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
MICA (UNII: V8A1AW0880)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CERAMIDE NP (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TROMETHAMINE (UNII: 023C2WHX2V)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0113-21 in 1 BOX10/19/201811/16/2020
1NDC:43596-0113-13.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/19/201811/16/2020
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  FUCSIA RADIANT/RED
octinoxate and zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
ISODODECANE (UNII: A8289P68Y2)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
MICA (UNII: V8A1AW0880)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CERAMIDE NP (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TROMETHAMINE (UNII: 023C2WHX2V)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0114-21 in 1 BOX10/19/201811/16/2020
1NDC:43596-0114-13.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/19/201811/16/2020
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  SALMON/RED
octinoxate and zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0115
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
ISODODECANE (UNII: A8289P68Y2)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
MICA (UNII: V8A1AW0880)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CERAMIDE NP (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TROMETHAMINE (UNII: 023C2WHX2V)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0115-21 in 1 BOX10/19/201811/16/2020
1NDC:43596-0115-13.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/19/201811/16/2020
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  FUCSIA/RED
octinoxate and zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0116
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
ISODODECANE (UNII: A8289P68Y2)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
MICA (UNII: V8A1AW0880)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CERAMIDE NP (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TROMETHAMINE (UNII: 023C2WHX2V)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0116-21 in 1 BOX10/19/201811/16/2020
1NDC:43596-0116-13.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/19/201811/16/2020
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  BURDEOS/RED
octinoxate and zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0117
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
ISODODECANE (UNII: A8289P68Y2)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
MICA (UNII: V8A1AW0880)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CERAMIDE NP (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TROMETHAMINE (UNII: 023C2WHX2V)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0117-21 in 1 BOX10/19/201811/16/2020
1NDC:43596-0117-13.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/19/201811/16/2020
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  CARAMEL TOASTED/BROWN
octinoxate and zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0118
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
ISODODECANE (UNII: A8289P68Y2)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
MICA (UNII: V8A1AW0880)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CERAMIDE NP (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TROMETHAMINE (UNII: 023C2WHX2V)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0118-21 in 1 BOX10/19/201811/16/2020
1NDC:43596-0118-13.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/19/201811/16/2020
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(43596-0108, 43596-0109, 43596-0110, 43596-0111, 43596-0112, 43596-0113, 43596-0114, 43596-0115, 43596-0116, 43596-0117, 43596-0118)

Revised: 11/2020
Document Id: b441118e-1543-ba38-e053-2995a90a8f52
Set id: 2637488f-850c-4bd4-bfed-5478010de95b
Version: 3
Effective Time: 20201116
 
Ventura Corporation LTD