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
Ventura International LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

LBEL Clarité Clarifying Effect Foundation SPF 30

Drug Facts

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.

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

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

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

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

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

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

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

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

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

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

L'BEL
CLARITÉ
Clarifying effect foundation SPF 30

Net Wt. 0.31 oz. e (9 g)

Principal Display Panel - 9 g Container Box - Claire 9/Brown

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:14783-213
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-213-02	1 in 1 BOX	12/26/2018
1	NDC:14783-213-01	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/26/2018

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:14783-214
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-214-02	1 in 1 BOX	12/26/2018
1	NDC:14783-214-01	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/26/2018

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:14783-215
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-215-02	1 in 1 BOX	12/26/2018
1	NDC:14783-215-01	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/26/2018

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:14783-217
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-217-02	1 in 1 BOX	12/26/2018
1	NDC:14783-217-01	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/26/2018

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:14783-218
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-218-02	1 in 1 BOX	12/26/2018
1	NDC:14783-218-01	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/26/2018

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:14783-219
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-219-02	1 in 1 BOX	12/26/2018
1	NDC:14783-219-01	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/26/2018

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:14783-220
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-220-02	1 in 1 BOX	12/26/2018
1	NDC:14783-220-01	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/26/2018

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:14783-221
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-221-02	1 in 1 BOX	12/26/2018
1	NDC:14783-221-01	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/26/2018

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:14783-216
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-216-02	1 in 1 BOX	12/26/2018
1	NDC:14783-216-01	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/26/2018

Labeler - Ventura International LTD (603192787)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-213, 14783-214, 14783-215, 14783-217, 14783-218, 14783-219, 14783-220, 14783-221, 14783-216)

Revised: 12/2018

Document Id: 4a1f8fe0-9497-481f-aca7-dc023f67b28b

Set id: bf9a454d-fe88-45f3-b926-f5d847c78211

Version: 1

Effective Time: 20181220

Ventura International LTD