LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 1- BEIGE- octinoxate, oxybenzone, and zinc oxide suspension
LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 2- BEIGE- octinoxate, oxybenzone, and zinc oxide suspension
LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 3- BEIGE- octinoxate, oxybenzone, and zinc oxide suspension
LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 4- BEIGE- octinoxate, oxybenzone, and zinc oxide suspension
LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 MEDIUM 5- BEIGE- octinoxate, oxybenzone, and zinc oxide suspension
LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 MEDIUM 6- BEIGE- octinoxate, oxybenzone, and zinc oxide suspension
LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 MEDIUM 7- BEIGE- octinoxate, oxybenzone, and zinc oxide suspension
LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 OBSCURE 8- BROWN- octinoxate, oxybenzone, and zinc oxide suspension
LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 OBSCURE 9- BROWN- octinoxate, oxybenzone, and zinc oxide suspension
Ventura Corporation LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

L'BEL CLARITÉ Clarifying Effect Foundation SPF 30

Drug Facts

Active Ingredients	Purpose
OCTINOXATE 7.50 %	Sunscreen
OXYBENZONE 2.00 %	Sunscreen
ZINC OXIDE 1.96 %	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

ISOSTEARYL NEOPENTANOATE, MICA, C12-15 ALKYL BENZOATE, ETHYLHEXYL PALMITATE, POLYMETHYL METHACRYLATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, OZOKERITE, KAOLIN, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA) WAX), ZEA MAYS STARCH (ZEA MAYS (CORN) STARCH), KOJIC DIPALMITATE, DIMETHICONE, OCTYLDODECANOL, PHENOXYETHANOL, GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, SILICA, BUTYROSPERMUM PARKII BUTTER (BUTYROSPERMUM PARKII (SHEA) BUTTER), CERA MICROCRISTALLINA (MICROCRYSTALLINE WAX), CAPRYLYL GLYCOL, BETA-SITOSTEROL, CHLORPHENESIN, PARFUM (FRAGRANCE), CANDELILLA CERA (EUPHORBIA CERIFERA (CANDELILLA) WAX), TRIMETHYLSILOXYSILICATE, GLYCYRRHIZA GLABRA ROOT EXTRACT (GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT), PETROLATUM, PHOSPHOLIPIDS, TRIETHOXYCAPRYLYLSILANE, CHOLESTEROL, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, SYNTHETIC BEESWAX, GLYCOSPHINGOLIPIDS, POLYETHYLENE.

MAY CONTAIN : CI 77891 (TITANIUM DIOXIDE), CI 77492 (IRON OXIDES), CI 77491 (IRON OXIDES), CI 77499 (IRON OXIDES).

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

PRINCIPAL DISPLAY PANEL - 9 g Case Box - CLAIRE 1- BEIGE

L'BEL
CLARITÉ
Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - 9 g Case Box - CLAIRE 1- BEIGE

PRINCIPAL DISPLAY PANEL - 9 g Case Box - CLAIRE 2- BEIGE

L'BEL
CLARITÉ
Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - 9 g Case Box - CLAIRE 2- BEIGE

PRINCIPAL DISPLAY PANEL - 9 g Case Box - CLAIRE 3- BEIGE

L'BEL
CLARITÉ
Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - 9 g Case Box - CLAIRE 3- BEIGE

PRINCIPAL DISPLAY PANEL - 9 g Case Box - CLAIRE 4- BEIGE

L'BEL
CLARITÉ
Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - 9 g Case Box - CLAIRE 4- BEIGE

PRINCIPAL DISPLAY PANEL - 9 g Case Box - MEDIUM 5- BEIGE

L'BEL
CLARITÉ
Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - 9 g Case Box - MEDIUM 5- BEIGE

PRINCIPAL DISPLAY PANEL - 9 g Case Box - MEDIUM 6- BEIGE

L'BEL
CLARITÉ
Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - 9 g Case Box - MEDIUM 6- BEIGE

PRINCIPAL DISPLAY PANEL - 9 g Case Box - MEDIUM 7- BEIGE

L'BEL
CLARITÉ
Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - 9 g Case Box - MEDIUM 7- BEIGE

PRINCIPAL DISPLAY PANEL - 9 g Case Box - OBSCURE 8- BROWN

L'BEL
CLARITÉ
Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - 9 g Case Box - OBSCURE 8- BROWN

PRINCIPAL DISPLAY PANEL - 9 g Case Box - OBSCURE 9- BROWN

L'BEL
CLARITÉ
Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - 9 g Case Box - OBSCURE 9- BROWN

PRINCIPAL DISPLAY PANEL - Kit Label

L'BEL

CLARITÉ

Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

Principal Display Panel - Kit Label

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 1- BEIGE
octinoxate, oxybenzone, and zinc oxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-943
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
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0196 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
MICA (UNII: V8A1AW0880)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
CERESIN (UNII: Q1LS2UJO3A)
KAOLIN (UNII: 24H4NWX5CO)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SHEA BUTTER (UNII: K49155WL9Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CHLORPHENESIN (UNII: I670DAL4SZ)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-943-02	1 in 1 BOX	06/06/2016
1	NDC:13537-943-01	9 g in 1 CASE; 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	06/06/2016

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 2- BEIGE
octinoxate, oxybenzone, and zinc oxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-944
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
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0196 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
MICA (UNII: V8A1AW0880)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
CERESIN (UNII: Q1LS2UJO3A)
KAOLIN (UNII: 24H4NWX5CO)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SHEA BUTTER (UNII: K49155WL9Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CHLORPHENESIN (UNII: I670DAL4SZ)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-944-02	1 in 1 BOX	06/06/2016
1	NDC:13537-944-01	9 g in 1 CASE; 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	06/06/2016

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 3- BEIGE
octinoxate, oxybenzone, and zinc oxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-945
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
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0196 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
MICA (UNII: V8A1AW0880)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
CERESIN (UNII: Q1LS2UJO3A)
KAOLIN (UNII: 24H4NWX5CO)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SHEA BUTTER (UNII: K49155WL9Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CHLORPHENESIN (UNII: I670DAL4SZ)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-945-02	1 in 1 BOX	06/06/2016
1	NDC:13537-945-01	9 g in 1 CASE; 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	06/06/2016

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 4- BEIGE
octinoxate, oxybenzone, and zinc oxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-946
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
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0196 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
MICA (UNII: V8A1AW0880)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
CERESIN (UNII: Q1LS2UJO3A)
KAOLIN (UNII: 24H4NWX5CO)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SHEA BUTTER (UNII: K49155WL9Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CHLORPHENESIN (UNII: I670DAL4SZ)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-946-02	1 in 1 BOX	06/06/2016
1	NDC:13537-946-01	9 g in 1 CASE; 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	06/06/2016

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 MEDIUM 5- BEIGE
octinoxate, oxybenzone, and zinc oxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-947
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
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0196 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
MICA (UNII: V8A1AW0880)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
CERESIN (UNII: Q1LS2UJO3A)
KAOLIN (UNII: 24H4NWX5CO)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SHEA BUTTER (UNII: K49155WL9Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CHLORPHENESIN (UNII: I670DAL4SZ)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-947-02	1 in 1 BOX	06/06/2016
1	NDC:13537-947-01	9 g in 1 CASE; 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	06/06/2016

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 MEDIUM 6- BEIGE
octinoxate, oxybenzone, and zinc oxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-948
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
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0196 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
MICA (UNII: V8A1AW0880)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
CERESIN (UNII: Q1LS2UJO3A)
KAOLIN (UNII: 24H4NWX5CO)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SHEA BUTTER (UNII: K49155WL9Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CHLORPHENESIN (UNII: I670DAL4SZ)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-948-02	1 in 1 BOX	06/06/2016
1	NDC:13537-948-01	9 g in 1 CASE; 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	06/06/2016

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 MEDIUM 7- BEIGE
octinoxate, oxybenzone, and zinc oxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-949
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
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0196 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
MICA (UNII: V8A1AW0880)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
CERESIN (UNII: Q1LS2UJO3A)
KAOLIN (UNII: 24H4NWX5CO)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SHEA BUTTER (UNII: K49155WL9Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CHLORPHENESIN (UNII: I670DAL4SZ)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-949-02	1 in 1 BOX	06/06/2016
1	NDC:13537-949-01	9 g in 1 CASE; 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	06/06/2016

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 OBSCURE 8- BROWN
octinoxate, oxybenzone, and zinc oxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-950
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
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0196 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
MICA (UNII: V8A1AW0880)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
CERESIN (UNII: Q1LS2UJO3A)
KAOLIN (UNII: 24H4NWX5CO)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SHEA BUTTER (UNII: K49155WL9Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CHLORPHENESIN (UNII: I670DAL4SZ)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-950-02	1 in 1 BOX	06/06/2016
1	NDC:13537-950-01	9 g in 1 CASE; 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	06/06/2016

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 OBSCURE 9- BROWN
octinoxate, oxybenzone, and zinc oxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-951
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
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0196 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
MICA (UNII: V8A1AW0880)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
CERESIN (UNII: Q1LS2UJO3A)
KAOLIN (UNII: 24H4NWX5CO)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SHEA BUTTER (UNII: K49155WL9Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CHLORPHENESIN (UNII: I670DAL4SZ)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-951-02	1 in 1 BOX	06/06/2016
1	NDC:13537-951-01	9 g in 1 CASE; 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	06/06/2016

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-943, 13537-944, 13537-945, 13537-946, 13537-947, 13537-948, 13537-949, 13537-950, 13537-951)

Revised: 12/2019

Document Id: 8546fddc-8b11-417e-9cbe-128274b134e8

Set id: c4eb1364-60a8-4647-b4cf-911c409de29c

Version: 4

Effective Time: 20191223

Ventura Corporation LTD