L'BEL CLARITÉ MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30

LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 280-F by

Drug Labeling and Warnings

LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 280-F by is a Otc medication manufactured, distributed, or labeled by Bel Star S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 270-C- octinoxate, zinc oxide paste 
LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 300-N- octinoxate, zinc oxide paste 
LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 330-C- octinoxate, zinc oxide paste 
LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 260-N- octinoxate, zinc oxide paste 
LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 290-C- octinoxate, zinc oxide paste 
LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 320-C- octinoxate, zinc oxide paste 
LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 250-F- octinoxate, zinc oxide paste 
LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 280-F- octinoxate, zinc oxide paste 
Bel Star S.A.

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L'BEL CLARITÉ MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30

Drug Facts

Active Ingredients

Octinoxate 7.50%

Zinc oxide 7.84%

Purpose

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 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

Dimethicone, mica, dicaprylyl carbonate, zea mays (corn) starch, oxokerite, polyethylene, cetyl diglyceryl tris(trimethylsiloxy)silyethyl 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.

Company Information

PUERTO RICO: Dist. by Ventura Corp. Ltd., San Juan, Puerto Rico 00926. Made in Columbia.

www.lbel.com

Product Packaging 250-F

Product Packaging 260-N

Product Packaging 270-C

Product Packaging 280-F

Product Packaging 290-C

Product Packaging 300-N

Product Packaging 320-C

Product Packaging 330-C

LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 270-C 
octinoxate, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	78.4 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STARCH, CORN (UNII: O8232NY3SJ)
CERESIN (UNII: Q1LS2UJO3A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-011-01	1 in 1 BOX	01/01/2022
1		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 Drug	M020	01/01/2022	01/01/2022

LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 300-N 
octinoxate, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	78.4 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STARCH, CORN (UNII: O8232NY3SJ)
CERESIN (UNII: Q1LS2UJO3A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-014-01	1 in 1 BOX	01/01/2022
1		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 Drug	M020	01/01/2022	01/01/2022

LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 330-C 
octinoxate, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	78.4 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STARCH, CORN (UNII: O8232NY3SJ)
CERESIN (UNII: Q1LS2UJO3A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-016-01	1 in 1 BOX	01/01/2022
1		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 Drug	M020	01/01/2022	01/01/2022

LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 260-N 
octinoxate, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	78.4 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STARCH, CORN (UNII: O8232NY3SJ)
CERESIN (UNII: Q1LS2UJO3A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-010-01	1 in 1 BOX	01/01/2022
1		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 Drug	M020	01/01/2022	01/01/2022

LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 290-C 
octinoxate, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	78.4 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STARCH, CORN (UNII: O8232NY3SJ)
CERESIN (UNII: Q1LS2UJO3A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-013-01	1 in 1 BOX	01/01/2022
1		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 Drug	M020	01/01/2022	01/01/2022

LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 320-C 
octinoxate, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	78.4 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STARCH, CORN (UNII: O8232NY3SJ)
CERESIN (UNII: Q1LS2UJO3A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-015-01	1 in 1 BOX	01/01/2022
1		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 Drug	M020	01/01/2022	01/01/2022

LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 250-F 
octinoxate, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	78.4 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STARCH, CORN (UNII: O8232NY3SJ)
CERESIN (UNII: Q1LS2UJO3A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-009-01	1 in 1 BOX	01/01/2022
1		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 Drug	M020	01/01/2022	01/01/2022

LBEL CLARITE MAKEUP FOUNDATION FOR A CLEARER APPEARANCE SPF 30 280-F 
octinoxate, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	78.4 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STARCH, CORN (UNII: O8232NY3SJ)
CERESIN (UNII: Q1LS2UJO3A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-012-01	1 in 1 BOX	01/01/2022
1		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 Drug	M020	01/01/2022	01/01/2022

Labeler - Bel Star S.A. (880160197)

Revised: 12/2023

Document Id: 0cd47d33-ca71-0158-e063-6294a90a9003

34390-5

Set id: d22f5976-924a-9c2c-e053-2a95a90affa8

Version: 2

Effective Time: 20231218