CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 110-C- octinoxate, zinc oxide cream CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 130-F- octinoxate, zinc oxide cream CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 140-C- octinoxate, zinc oxide cream CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 150-C- octinoxate, zinc oxide cream CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 420-C- octinoxate, zinc oxide cream CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 450-C- octinoxate, zinc oxide cream CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 460-F- octinoxate, zinc oxide cream CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 470-N- octinoxate, zinc oxide cream

Clarite Makeup for a Cleaner appearance SPF 30 470-N by

Drug Labeling and Warnings

Clarite Makeup for a Cleaner appearance SPF 30 470-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

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.

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 110-C

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 130-F

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 140-C

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 150-C

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 160-N

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 170-N

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 180-F

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 200-C

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 210-F

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 220-C

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 230-N

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 240-C

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 250-F

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 260-N

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 270-C

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 280-F

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 290-C

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 300-N

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 310-C

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 320-C

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Makeup foundation for a clearer appearance SPF 30 330-C

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

L'Bel CLARITE
Base de maquillage para una apariencia mas clara FPS 30
Makeup foundation for a clearer appearance SPF 30 340-F

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

L'Bel CLARITE
Base de maquillage para una apariencia mas clara FPS 30
Makeup foundation for a clearer appearance SPF 30 350-N

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

L'Bel CLARITE
Base de maquillage para una apariencia mas clara FPS 30
Makeup foundation for a clearer appearance SPF 30 370-C

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

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

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

L'Bel CLARITE
Base de maquillage para una apariencia mas clara FPS 30
Makeup foundation for a clearer appearance SPF 30 410-N

Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

L'Bel CLARITE
Base de maquillage para una apariencia mas clara FPS 30
Makeup foundation for a clearer appearance SPF 30 420-C
Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

L'Bel CLARITE
Base de maquillage para una apariencia mas clara FPS 30
Makeup foundation for a clearer appearance SPF 30 450-C
Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

L'Bel CLARITE
Base de maquillage para una apariencia mas clara FPS 30
Makeup foundation for a clearer appearance SPF 30 460-F
Net Wt. 0.31 oz. e (9g)

PRINCIPAL DISPLAY PANEL

L'Bel CLARITE
Base de maquillage para una apariencia mas clara FPS 30
Makeup foundation for a clearer appearance SPF 30 470-N
Net Wt. 0.31 oz. e (9g)

INGREDIENTS AND APPEARANCE

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 110-C 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0143
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CERESIN (UNII: Q1LS2UJO3A)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0143-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 130-F 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0144
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
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
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: 43596-0144-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 140-C 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0145
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0145-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 150-C 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0146
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0146-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 160-N 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0147
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
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0147-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 170-N 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0148
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0148-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 180-F 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0149
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0149-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 200-C 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0150
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
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0150-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 210-F 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0151
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
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0151-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 220-C 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0152
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0152-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 230-N 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0153
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0153-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 240-C 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0154
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
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0154-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 250-F 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0155
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0155-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 260-N 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0156
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
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0156-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 270-C 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0157
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0157-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 280-F 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0158
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0158-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 290-C 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0159
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
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0159-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 300-N 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0160
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
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0160-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 310-C 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0161
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0161-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 320-C 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0162
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0162-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 330-C 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0163
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0163-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 340-F 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0164
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
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CERESIN (UNII: Q1LS2UJO3A)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0164-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 350-N 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0165
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
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0165-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 370-C 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0166
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
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0166-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 390-N 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0167
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
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0167-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 410-N 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0168
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0168-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 420-C 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0173
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0173-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 450-C 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0170
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
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0170-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 460-F 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0171
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
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0171-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

CLARITE MAKEUP FOR A CLEANER APPEARANCE SPF 30 470-N 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0172
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
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0172-1	9 g in 1 JAR; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2020

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
BEL STAR S A		880160197	manufacture(43596-0143, 43596-0144, 43596-0145, 43596-0146, 43596-0147, 43596-0148, 43596-0149, 43596-0150, 43596-0151, 43596-0152, 43596-0153, 43596-0154, 43596-0155, 43596-0156, 43596-0157, 43596-0158, 43596-0159, 43596-0160, 43596-0161, 43596-0162, 43596-0163, 43596-0164, 43596-0165, 43596-0166, 43596-0167, 43596-0168, 43596-0173, 43596-0170, 43596-0171, 43596-0172)