Drug Facts

Active Ingredients	Purpose
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 Int Ltd.
DBA Belcorp USA, Miami, FL
33126

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

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

LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 ROUGE AMORE/RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-158
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-158-02	1 in 1 BOX	10/19/2018	11/16/2020
1	NDC:14783-158-01	3.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/19/2018	11/16/2020

LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 ROUGE CORAIL/RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-159
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-159-02	1 in 1 BOX	10/19/2018
1	NDC:14783-159-01	3.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/19/2018

LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 ROUGE/RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-178
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-178-02	1 in 1 BOX	10/19/2018
1	NDC:14783-178-01	3.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/19/2018

LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 FRAMBOISE/RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-161
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-161-02	1 in 1 BOX	10/19/2018	11/16/2020
1	NDC:14783-161-01	3.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/19/2018	11/16/2020

LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 FUCSIA ROYAL/RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-162
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-162-02	1 in 1 BOX	10/19/2018	11/16/2020
1	NDC:14783-162-01	3.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/19/2018	11/16/2020

LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 ROSE NUDE/RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-163
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-163-02	1 in 1 BOX	10/19/2018
1	NDC:14783-163-01	3.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/19/2018

LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 FUCSIA RADIANT/RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-164
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-164-02	1 in 1 BOX	10/19/2018	11/16/2020
1	NDC:14783-164-01	3.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/19/2018	11/16/2020

LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 SALMON/RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-165
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-165-02	1 in 1 BOX	10/19/2018	11/16/2020
1	NDC:14783-165-01	3.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/19/2018	11/16/2020

LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 FUCSIA/RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-166
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-166-02	1 in 1 BOX	10/19/2018
1	NDC:14783-166-01	3.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/19/2018

LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 BURDEOS/RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-167
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-167-02	1 in 1 BOX	10/19/2018
1	NDC:14783-167-01	3.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/19/2018

LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 CARAMEL TOASTED/BROWN
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-168
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-168-02	1 in 1 BOX	10/19/2018	11/16/2020
1	NDC:14783-168-01	3.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/19/2018	11/16/2020

LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 MALVA NUDE/RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-169
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-169-02	1 in 1 BOX	10/19/2018	11/16/2020
1	NDC:14783-169-01	3.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/19/2018	11/16/2020

Labeler - Ventura International LTD (603192787)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	manufacture(14783-158, 14783-159, 14783-178, 14783-161, 14783-162, 14783-163, 14783-164, 14783-165, 14783-166, 14783-167, 14783-168, 14783-169)

L'BEL CONCENTRÉ TOTAL LABIOS LIPSTICK GLOBAL PERFECTION SPF 20

Uses

Warnings

Directions

Other information

Inactive ingredients

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

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

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

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

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

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

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

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

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

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

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

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