LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 1/BEIGE- octinoxate and zinc oxide liquid LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 2/BEIGE- octinoxate and zinc oxide liquid LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 3/BEIGE- octinoxate and zinc oxide liquid LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 4/BEIGE- octinoxate and zinc oxide liquid LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 5/BEIGE- octinoxate and zinc oxide liquid LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 6/BEIGE- octinoxate and zinc oxide liquid LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 7/BEIGE- octinoxate and zinc oxide liquid LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 8/BEIGE- octinoxate and zinc oxide liquid LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 9/BROWN- octinoxate and zinc oxide liquid

LBEL Clarite Clarifying Effect Foundation SPF 30 by

Drug Labeling and Warnings

LBEL Clarite Clarifying Effect Foundation SPF 30 by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
OCTINOXATE 7.50 %	Sunscreen
ZINC OXIDE 7.84 %	Sunscreen

Uses

• Helps prevent sunburn.

Warnings

• Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
• For external use only.

• Do not use on damaged or broken skin.

• When using this product keep out of eyes. Rinse with water to remove.

• Stop use and ask a doctor if rash occurs.

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

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months of age: Ask a doctor

Other information

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Dimethicone, mica, zea mays (corn) starch, ozokerite, polyethylene, silica dimethyl silylate, peg/ppg-18/18 dimethicone, copernicia cerifera (carnauba) wax, kojic dipalmitate, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, hexyl laurate, phenoxyethanol, triethoxycaprylylsilane, caprylyl glycol, chlorphenesin, fragrante, glycyrrhiza glabra (licorice) root extract, trimethylsiloxysilicate, dimethylmethoxy chromanyl palmitato, citronellol, butylphenyl methylpropional, hydroxycitronellal, hexyl cinnamal, d-limonene, hydroxyisohexyl 3-cyclohexene carboxaldehyde, alpha-isomethyl ionone.

May Contain: titanium dioxide, iron oxides.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 9 g Case Box - Claire 1/Beige

L'BEL

CLARITÉ

Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - 9 g Case Box - Claire 2/Beige

L'BEL

CLARITÉ

Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - 9 g Case Box - Claire 3/Beige

L'BEL

CLARITÉ

Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - 9 g Case Box - Claire 4/Beige

L'BEL

CLARITÉ

Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - 9 g Case Box - Claire 5/Beige

L'BEL

CLARITÉ

Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - 9 g Case Box - Claire 6/Beige

L'BEL

CLARITÉ

Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - 9 g Case Box - Claire 7/Beige

L'BEL

CLARITÉ

Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - 9 g Case Box - Claire 8/Beige

L'BEL

CLARITÉ

Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

PRINCIPAL DISPLAY PANEL - 9 g Case Box - Claire 9/Brown

L'BEL

CLARITÉ

Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

INGREDIENTS AND APPEARANCE

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 1/BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0784 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Dimethicone (UNII: 92RU3N3Y1O)
mica (UNII: V8A1AW0880)
starch, corn (UNII: O8232NY3SJ)
high density polyethylene (UNII: UG00KM4WR7)
silica dimethyl silylate (UNII: EU2PSP0G0W)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
carnauba wax (UNII: R12CBM0EIZ)
kojic dipalmitate (UNII: 13N249RWTM)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
hexyl laurate (UNII: 4CG9F9W01Q)
phenoxyethanol (UNII: HIE492ZZ3T)
triethoxycaprylylsilane (UNII: LDC331P08E)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
licorice (UNII: 61ZBX54883)
dimethylmethoxy chromanyl palmitate (UNII: 5G222ZDK7U)
.beta.-citronellol, (R)- (UNII: P01OUT964K)
butylphenyl methylpropional (UNII: T7540GJV69)
hydroxycitronellal (UNII: 8SQ0VA4YUR)
.alpha.-hexylcinnamaldehyde (UNII: 7X6O37OK2I)
limonene, (+)- (UNII: GFD7C86Q1W)
hydroxyisohexyl 3-cyclohexene carboxaldehyde (UNII: QUE43B9Z2Q)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0126-2	1 in 1 BOX	09/26/2018
1	NDC: 43596-0126-1	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/26/2018

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 2/BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0784 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Dimethicone (UNII: 92RU3N3Y1O)
mica (UNII: V8A1AW0880)
starch, corn (UNII: O8232NY3SJ)
high density polyethylene (UNII: UG00KM4WR7)
silica dimethyl silylate (UNII: EU2PSP0G0W)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
carnauba wax (UNII: R12CBM0EIZ)
kojic dipalmitate (UNII: 13N249RWTM)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
hexyl laurate (UNII: 4CG9F9W01Q)
phenoxyethanol (UNII: HIE492ZZ3T)
triethoxycaprylylsilane (UNII: LDC331P08E)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
licorice (UNII: 61ZBX54883)
dimethylmethoxy chromanyl palmitate (UNII: 5G222ZDK7U)
.beta.-citronellol, (R)- (UNII: P01OUT964K)
butylphenyl methylpropional (UNII: T7540GJV69)
hydroxycitronellal (UNII: 8SQ0VA4YUR)
.alpha.-hexylcinnamaldehyde (UNII: 7X6O37OK2I)
limonene, (+)- (UNII: GFD7C86Q1W)
hydroxyisohexyl 3-cyclohexene carboxaldehyde (UNII: QUE43B9Z2Q)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0127-2	1 in 1 BOX	09/26/2018
1	NDC: 43596-0127-1	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/26/2018

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 3/BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0128
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0784 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Dimethicone (UNII: 92RU3N3Y1O)
mica (UNII: V8A1AW0880)
starch, corn (UNII: O8232NY3SJ)
high density polyethylene (UNII: UG00KM4WR7)
silica dimethyl silylate (UNII: EU2PSP0G0W)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
carnauba wax (UNII: R12CBM0EIZ)
kojic dipalmitate (UNII: 13N249RWTM)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
hexyl laurate (UNII: 4CG9F9W01Q)
phenoxyethanol (UNII: HIE492ZZ3T)
triethoxycaprylylsilane (UNII: LDC331P08E)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
licorice (UNII: 61ZBX54883)
dimethylmethoxy chromanyl palmitate (UNII: 5G222ZDK7U)
.beta.-citronellol, (R)- (UNII: P01OUT964K)
butylphenyl methylpropional (UNII: T7540GJV69)
hydroxycitronellal (UNII: 8SQ0VA4YUR)
.alpha.-hexylcinnamaldehyde (UNII: 7X6O37OK2I)
limonene, (+)- (UNII: GFD7C86Q1W)
hydroxyisohexyl 3-cyclohexene carboxaldehyde (UNII: QUE43B9Z2Q)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0128-2	1 in 1 BOX	09/26/2018
1	NDC: 43596-0128-1	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/26/2018

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 4/BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0784 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Dimethicone (UNII: 92RU3N3Y1O)
mica (UNII: V8A1AW0880)
starch, corn (UNII: O8232NY3SJ)
high density polyethylene (UNII: UG00KM4WR7)
silica dimethyl silylate (UNII: EU2PSP0G0W)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
carnauba wax (UNII: R12CBM0EIZ)
kojic dipalmitate (UNII: 13N249RWTM)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
hexyl laurate (UNII: 4CG9F9W01Q)
phenoxyethanol (UNII: HIE492ZZ3T)
triethoxycaprylylsilane (UNII: LDC331P08E)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
licorice (UNII: 61ZBX54883)
dimethylmethoxy chromanyl palmitate (UNII: 5G222ZDK7U)
.beta.-citronellol, (R)- (UNII: P01OUT964K)
butylphenyl methylpropional (UNII: T7540GJV69)
hydroxycitronellal (UNII: 8SQ0VA4YUR)
.alpha.-hexylcinnamaldehyde (UNII: 7X6O37OK2I)
limonene, (+)- (UNII: GFD7C86Q1W)
hydroxyisohexyl 3-cyclohexene carboxaldehyde (UNII: QUE43B9Z2Q)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0129-2	1 in 1 BOX	09/26/2018
1	NDC: 43596-0129-1	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/26/2018

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 5/BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0784 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Dimethicone (UNII: 92RU3N3Y1O)
mica (UNII: V8A1AW0880)
starch, corn (UNII: O8232NY3SJ)
high density polyethylene (UNII: UG00KM4WR7)
silica dimethyl silylate (UNII: EU2PSP0G0W)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
carnauba wax (UNII: R12CBM0EIZ)
kojic dipalmitate (UNII: 13N249RWTM)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
hexyl laurate (UNII: 4CG9F9W01Q)
phenoxyethanol (UNII: HIE492ZZ3T)
triethoxycaprylylsilane (UNII: LDC331P08E)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
licorice (UNII: 61ZBX54883)
dimethylmethoxy chromanyl palmitate (UNII: 5G222ZDK7U)
.beta.-citronellol, (R)- (UNII: P01OUT964K)
butylphenyl methylpropional (UNII: T7540GJV69)
hydroxycitronellal (UNII: 8SQ0VA4YUR)
.alpha.-hexylcinnamaldehyde (UNII: 7X6O37OK2I)
limonene, (+)- (UNII: GFD7C86Q1W)
hydroxyisohexyl 3-cyclohexene carboxaldehyde (UNII: QUE43B9Z2Q)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0130-2	1 in 1 BOX	09/26/2018
1	NDC: 43596-0130-1	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/26/2018

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 6/BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0131
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0784 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Dimethicone (UNII: 92RU3N3Y1O)
mica (UNII: V8A1AW0880)
starch, corn (UNII: O8232NY3SJ)
high density polyethylene (UNII: UG00KM4WR7)
silica dimethyl silylate (UNII: EU2PSP0G0W)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
carnauba wax (UNII: R12CBM0EIZ)
kojic dipalmitate (UNII: 13N249RWTM)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
hexyl laurate (UNII: 4CG9F9W01Q)
phenoxyethanol (UNII: HIE492ZZ3T)
triethoxycaprylylsilane (UNII: LDC331P08E)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
licorice (UNII: 61ZBX54883)
dimethylmethoxy chromanyl palmitate (UNII: 5G222ZDK7U)
.beta.-citronellol, (R)- (UNII: P01OUT964K)
butylphenyl methylpropional (UNII: T7540GJV69)
hydroxycitronellal (UNII: 8SQ0VA4YUR)
.alpha.-hexylcinnamaldehyde (UNII: 7X6O37OK2I)
limonene, (+)- (UNII: GFD7C86Q1W)
hydroxyisohexyl 3-cyclohexene carboxaldehyde (UNII: QUE43B9Z2Q)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0131-2	1 in 1 BOX	09/26/2018
1	NDC: 43596-0131-1	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/26/2018

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 7/BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0132
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0784 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Dimethicone (UNII: 92RU3N3Y1O)
mica (UNII: V8A1AW0880)
starch, corn (UNII: O8232NY3SJ)
high density polyethylene (UNII: UG00KM4WR7)
silica dimethyl silylate (UNII: EU2PSP0G0W)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
carnauba wax (UNII: R12CBM0EIZ)
kojic dipalmitate (UNII: 13N249RWTM)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
hexyl laurate (UNII: 4CG9F9W01Q)
phenoxyethanol (UNII: HIE492ZZ3T)
triethoxycaprylylsilane (UNII: LDC331P08E)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
licorice (UNII: 61ZBX54883)
dimethylmethoxy chromanyl palmitate (UNII: 5G222ZDK7U)
.beta.-citronellol, (R)- (UNII: P01OUT964K)
butylphenyl methylpropional (UNII: T7540GJV69)
hydroxycitronellal (UNII: 8SQ0VA4YUR)
.alpha.-hexylcinnamaldehyde (UNII: 7X6O37OK2I)
limonene, (+)- (UNII: GFD7C86Q1W)
hydroxyisohexyl 3-cyclohexene carboxaldehyde (UNII: QUE43B9Z2Q)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0132-2	1 in 1 BOX	09/26/2018
1	NDC: 43596-0132-1	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/26/2018

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 8/BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0133
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0784 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Dimethicone (UNII: 92RU3N3Y1O)
mica (UNII: V8A1AW0880)
starch, corn (UNII: O8232NY3SJ)
high density polyethylene (UNII: UG00KM4WR7)
silica dimethyl silylate (UNII: EU2PSP0G0W)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
carnauba wax (UNII: R12CBM0EIZ)
kojic dipalmitate (UNII: 13N249RWTM)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
hexyl laurate (UNII: 4CG9F9W01Q)
phenoxyethanol (UNII: HIE492ZZ3T)
triethoxycaprylylsilane (UNII: LDC331P08E)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
licorice (UNII: 61ZBX54883)
dimethylmethoxy chromanyl palmitate (UNII: 5G222ZDK7U)
.beta.-citronellol, (R)- (UNII: P01OUT964K)
butylphenyl methylpropional (UNII: T7540GJV69)
hydroxycitronellal (UNII: 8SQ0VA4YUR)
.alpha.-hexylcinnamaldehyde (UNII: 7X6O37OK2I)
limonene, (+)- (UNII: GFD7C86Q1W)
hydroxyisohexyl 3-cyclohexene carboxaldehyde (UNII: QUE43B9Z2Q)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0133-2	1 in 1 BOX	09/26/2018
1	NDC: 43596-0133-1	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/26/2018

LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 9/BROWN
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0134
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0784 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Dimethicone (UNII: 92RU3N3Y1O)
mica (UNII: V8A1AW0880)
starch, corn (UNII: O8232NY3SJ)
high density polyethylene (UNII: UG00KM4WR7)
silica dimethyl silylate (UNII: EU2PSP0G0W)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
carnauba wax (UNII: R12CBM0EIZ)
kojic dipalmitate (UNII: 13N249RWTM)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
hexyl laurate (UNII: 4CG9F9W01Q)
phenoxyethanol (UNII: HIE492ZZ3T)
triethoxycaprylylsilane (UNII: LDC331P08E)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
licorice (UNII: 61ZBX54883)
dimethylmethoxy chromanyl palmitate (UNII: 5G222ZDK7U)
.beta.-citronellol, (R)- (UNII: P01OUT964K)
butylphenyl methylpropional (UNII: T7540GJV69)
hydroxycitronellal (UNII: 8SQ0VA4YUR)
.alpha.-hexylcinnamaldehyde (UNII: 7X6O37OK2I)
limonene, (+)- (UNII: GFD7C86Q1W)
hydroxyisohexyl 3-cyclohexene carboxaldehyde (UNII: QUE43B9Z2Q)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0134-2	1 in 1 BOX	09/26/2018
1	NDC: 43596-0134-1	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/26/2018

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(43596-0126, 43596-0127, 43596-0128, 43596-0129, 43596-0130, 43596-0131, 43596-0132, 43596-0133, 43596-0134)