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

LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 by

Drug Labeling and Warnings

LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 by is a Otc medication manufactured, distributed, or labeled by Ventura International LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

PURPOSE

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.

SPL UNCLASSIFIED SECTION

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 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/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

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

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

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

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

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

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

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

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

L'BEL

CONCENTRÉ
TOTAL
LABIOS

lipstick
global
perfection SPF 20

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Ventura International LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
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)