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 
Bel Star S.A. (Colombia)

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)

Rouge Corail

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)

Rouge

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)

Rose Nude

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)

Fucsia

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)

Burdeos

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:14141-108
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:14141-108-021 in 1 BOX10/19/201811/16/2020
1NDC:14141-108-013.4 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:14141-109
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:14141-109-021 in 1 BOX10/19/2018
1NDC:14141-109-013.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/19/201806/26/2022
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  ROUGE/RED
octinoxate and zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-110
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:14141-110-021 in 1 BOX10/19/2018
1NDC:14141-110-013.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/19/201802/21/2022
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20   FRAMBOISE/RED
octinoxate and zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-111
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:14141-111-021 in 1 BOX10/19/201811/16/2020
1NDC:14141-111-013.4 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:14141-112
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
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)  
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14141-112-021 in 1 BOX10/19/201811/16/2020
1NDC:14141-112-013.4 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:14141-113
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:14141-113-021 in 1 BOX10/19/2018
1NDC:14141-113-013.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/19/201808/22/2021
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:14141-114
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:14141-114-021 in 1 BOX10/19/201811/16/2020
1NDC:14141-114-013.4 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:14141-115
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:14141-115-021 in 1 BOX10/19/201811/16/2020
1NDC:14141-115-013.4 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:14141-116
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:14141-116-021 in 1 BOX10/19/2018
1NDC:14141-116-013.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/19/201806/18/2021
LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  BURDEOS/RED
octinoxate and zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-117
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:14141-117-021 in 1 BOX10/19/2018
1NDC:14141-117-013.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/19/201808/26/2021
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:14141-118
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:14141-118-021 in 1 BOX10/19/201811/16/2020
1NDC:14141-118-013.4 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 - Bel Star S.A. (Colombia) (880160197)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(14141-108, 14141-109, 14141-110, 14141-111, 14141-112, 14141-113, 14141-114, 14141-115, 14141-116, 14141-117, 14141-118)

Revised: 3/2022
 
Bel Star S.A. (Colombia)