CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 170-N- octinoxate, zinc oxide paste CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 180-F- octinoxate, zinc oxide paste CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 220-C- octinoxate, zinc oxide paste CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 230-N- octinoxate, zinc oxide paste CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 310-C- octinoxate, zinc oxide paste CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 390-N- octinoxate, zinc oxide paste

Clarite Makeup Foundation for a Clearer Appearance SPF 30 390-N by

Drug Labeling and Warnings

Clarite Makeup Foundation for a Clearer Appearance SPF 30 390-N by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, BEL STAR S A. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Octinoxate 7.50% Sunscreen

Zinc Oxide 7.84% Sunscreen

PURPOSE

Uses

• Helps prevent sunburn

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 six months of age: Ask a doctor

OTHER SAFETY INFORMATION

Other information:

Protect the product in this container from excessive hear and direct sun

INACTIVE INGREDIENT

Inactive ingredients: Dimethicone, mica, dicaprylyl carbonate, zea mays (corn) starch, ozokerite, polyethylene, cetyl diglyceryl tris(trimethylsiloxy)silylethyl dimethicone, silica dimethyl silylate, copernicia cerifera (carnauba) wax, kojic dipalmitate, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, hexyl laurate, phenoxyethanol, disteardimonium hectorite, triethoxycaprylylsilane, caprylyl glycol, chlorphenesin, fragrance, glycyrrhiza glabra (licorice) root extract, trimethylsiloxysilicate, dimethylmethoxy chromanyl palmitate, butylphenyl methylpropional, citronellol, hydroxycitronellal, hexyl cinnamal, limonene, alpha-isomethyl ionone.
may contain: titanium dioxide, iron oxides.

170-N

L'Bel CLARITE
Base de maquillaje para una apariencia mas clara FPS 30

Makeup foundation for a clearer appearance SPF 30 170-N

Net Wt. 0.31 oz. e (9g)

180-F

L'Bel CLARITE
Base de maquillaje para una apariencia mas clara FPS 30

Makeup foundation for a clearer appearance SPF 30 180-F

Net Wt. 0.31 oz. e (9g)

220-C

L'Bel CLARITE
Base de maquillaje para una apariencia mas clara FPS 30

Makeup foundation for a clearer appearance SPF 30 220-C

Net Wt. 0.31 oz. e (9g)

230-N

L'Bel CLARITE
Base de maquillaje para una apariencia mas clara FPS 30

Makeup foundation for a clearer appearance SPF 30 230-N

Net Wt. 0.31 oz. e (9g)

310-C

L'Bel CLARITE
Base de maquillaje para una apariencia mas clara FPS 30

Makeup foundation for a clearer appearance SPF 30 310-C

Net Wt. 0.31 oz. e (9g)

390-N

L'Bel CLARITE
Base de maquillaje para una apariencia mas clara FPS 30
Makeup foundation for a clearer appearance SPF 30 390-N

Net Wt. 0.31 oz. e (9g)

INGREDIENTS AND APPEARANCE

CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 170-N 
octinoxate, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0183
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.84 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STARCH, CORN (UNII: O8232NY3SJ)
CERESIN (UNII: Q1LS2UJO3A)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CARNAUBA WAX (UNII: R12CBM0EIZ)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0183-1	9 g in 1 CASE; Type 0: Not a Combination Product	11/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/09/2020

CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 180-F 
octinoxate, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0184
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.84 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STARCH, CORN (UNII: O8232NY3SJ)
CERESIN (UNII: Q1LS2UJO3A)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CARNAUBA WAX (UNII: R12CBM0EIZ)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0184-1	9 g in 1 CASE; Type 0: Not a Combination Product	11/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/09/2020

CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 220-C 
octinoxate, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0185
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.84 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STARCH, CORN (UNII: O8232NY3SJ)
CERESIN (UNII: Q1LS2UJO3A)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CARNAUBA WAX (UNII: R12CBM0EIZ)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0185-1	9 g in 1 CASE; Type 0: Not a Combination Product	11/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/09/2020

CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 230-N 
octinoxate, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0186
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.84 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STARCH, CORN (UNII: O8232NY3SJ)
CERESIN (UNII: Q1LS2UJO3A)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MICA (UNII: V8A1AW0880)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CARNAUBA WAX (UNII: R12CBM0EIZ)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0186-1	9 g in 1 CASE; Type 0: Not a Combination Product	11/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/09/2020

CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 310-C 
octinoxate, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0187
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.84 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STARCH, CORN (UNII: O8232NY3SJ)
CERESIN (UNII: Q1LS2UJO3A)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CARNAUBA WAX (UNII: R12CBM0EIZ)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0187-1	9 g in 1 CASE; Type 0: Not a Combination Product	11/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/09/2020

CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 390-N 
octinoxate, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0188
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.84 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STARCH, CORN (UNII: O8232NY3SJ)
CERESIN (UNII: Q1LS2UJO3A)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CARNAUBA WAX (UNII: R12CBM0EIZ)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0188-1	9 g in 1 CASE; Type 0: Not a Combination Product	11/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/09/2020

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
BEL STAR S A		880160197	manufacture(43596-0183, 43596-0184, 43596-0185, 43596-0186, 43596-0187, 43596-0188)