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

LBEL CLARITE Clarifying Effect Foundation SPF 30 by

Drug Labeling and Warnings

LBEL CLARITE Clarifying Effect Foundation SPF 30 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

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).

SPL UNCLASSIFIED SECTION

Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami, FL 33126

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 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 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 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 - 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 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 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 - 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 9 - BROWN

L'BEL

CLARITÉ

Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - Kit Label

L'BEL

CLARITÉ

Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

INGREDIENTS AND APPEARANCE

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: 14783-945
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
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-945-02	1 in 1 BOX	06/06/2016
1	NDC: 14783-945-01	9 g in 1 CASE; 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	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: 14783-946
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
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-946-02	1 in 1 BOX	06/06/2016
1	NDC: 14783-946-01	9 g in 1 CASE; 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	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: 14783-947
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
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-947-02	1 in 1 BOX	06/06/2016
1	NDC: 14783-947-01	9 g in 1 CASE; 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	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: 14783-948
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
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-948-02	1 in 1 BOX	06/06/2016
1	NDC: 14783-948-01	9 g in 1 CASE; 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	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: 14783-949
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
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-949-02	1 in 1 BOX	06/06/2016
1	NDC: 14783-949-01	9 g in 1 CASE; 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	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: 14783-950
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
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-950-02	1 in 1 BOX	06/06/2016
1	NDC: 14783-950-01	9 g in 1 CASE; 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	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: 14783-951
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
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-951-02	1 in 1 BOX	06/06/2016
1	NDC: 14783-951-01	9 g in 1 CASE; 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	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: 14783-952
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
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-952-02	1 in 1 BOX	06/06/2016
1	NDC: 14783-952-01	9 g in 1 CASE; 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	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: 14783-953
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
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-953-02	1 in 1 BOX	06/06/2016
1	NDC: 14783-953-01	9 g in 1 CASE; 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	06/06/2016

Labeler - Ventura International LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-945, 14783-946, 14783-947, 14783-948, 14783-949, 14783-950, 14783-951, 14783-952, 14783-953)