LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 CLAIRE 1 - BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 CLAIRE 2 - BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 CLAIRE 3 - BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 CLAIRE 4 - BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 MEDIUM 5 - BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 MEDIUM 6 - BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 MEDIUM 7 - BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 OBSCURE 8 - BEIGE- octinoxate, titanium dioxide, and zinc oxide paste

LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 by

Drug Labeling and Warnings

LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 by is a Otc medication manufactured, distributed, or labeled by Ventura International 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 6.50 %	Sunscreen
TITANIUM DIOXIDE 2.442 %	Sunscreen
ZINC OXIDE 1.568 %	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

CYCLOPENTASILOXANE, MICA, DIMETHICONE CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TRIMETHYLSILOXYSILICATE, CYCLOHEXASILOXANE, BIS-HYDROXYETHOXYPROPYL DIMETHICONE, OCTYLDODECANOL, PHENOXYETHANOL, BORON NITRIDE, DISTEARDIMONIUM HECTORITE, ALUMINA, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, MICROCRYSTALLINE WAX , SILICA, HEXYL LAURATE, DIMETHICONOL, CAPRYLYL GLYCOL, TOCOPHERYL ACETATE, CHLORPHENESIN, LAUROYL LYSINE, PETROLATUM, PROPYLENE CARBONATE, METHICONE, PHOSPHOLIPIDS, RHODIOLA ROSEA ROOT EXTRACT, CHOLESTEROL, BHA, BHT, CARNOSINE, TRIETHOXYCAPRYLYLSILANE, EUPHORBIA CERIFERA (CANDELILLA) WAX, BEESWAX, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, COPERNICIA CERIFERA (CARNAUBA) WAX, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, GLYCOSPHINGOLIPIDS, ALANYL GLUTAMINE.

MAY CONTAIN: TITANIUM DIOXIDE, IRON OXIDES.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLAIRE 1 - BEIGE

L'BEL

EFFET PARFAIT
MINÉRAL

natural skin effect
mousse foundation
SPF 16

Net Wt. 1 oz. (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLAIRE 2 - BEIGE

L'BEL

EFFET PARFAIT
MINÉRAL

natural skin effect
mousse foundation
SPF 16

Net Wt. 1 oz. (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLAIRE 3 - BEIGE

L'BEL

EFFET PARFAIT
MINÉRAL

natural skin effect
mousse foundation
SPF 16

Net Wt. 1 oz. (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLAIRE 4 - BEIGE

L'BEL

EFFET PARFAIT
MINÉRAL

natural skin effect
mousse foundation
SPF 16

Net Wt. 1 oz. (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIUM 5 - BEIGE

L'BEL

EFFET PARFAIT
MINÉRAL

natural skin effect
mousse foundation
SPF 16

Net Wt. 1 oz. (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIUM 6 - BEIGE

L'BEL

EFFET PARFAIT
MINÉRAL

natural skin effect
mousse foundation
SPF 16

Net Wt. 1 oz. (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIUM 7 - BEIGE

L'BEL

EFFET PARFAIT
MINÉRAL

natural skin effect
mousse foundation
SPF 16

Net Wt. 1 oz. (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - OBSCURE 8 - BEIGE

L'BEL

EFFET PARFAIT
MINÉRAL

natural skin effect
mousse foundation
SPF 16

Net Wt. 1 oz. (30 g)

INGREDIENTS AND APPEARANCE

LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   CLAIRE 1 - BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-000-02	1 in 1 BOX	11/02/2016
1	NDC: 14783-000-01	30 g in 1 TUBE; 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	11/02/2016

LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   CLAIRE 2 - BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-001-02	1 in 1 BOX	11/02/2016
1	NDC: 14783-001-01	30 g in 1 TUBE; 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	11/02/2016

LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   CLAIRE 3 - BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-002-02	1 in 1 BOX	11/02/2016
1	NDC: 14783-002-01	30 g in 1 TUBE; 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	11/02/2016

LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   CLAIRE 4 - BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-003-02	1 in 1 BOX	11/02/2016
1	NDC: 14783-003-01	30 g in 1 TUBE; 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	11/02/2016

LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   MEDIUM 5 - BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-004-02	1 in 1 BOX	11/02/2016
1	NDC: 14783-004-01	30 g in 1 TUBE; 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	11/02/2016

LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   MEDIUM 6 - BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-005-02	1 in 1 BOX	11/02/2016
1	NDC: 14783-005-01	30 g in 1 TUBE; 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	11/02/2016

LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   MEDIUM 7 - BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-006-02	1 in 1 BOX	11/02/2016
1	NDC: 14783-006-01	30 g in 1 TUBE; 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	11/02/2016

LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   OBSCURE 8 - BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-007-02	1 in 1 BOX	11/02/2016
1	NDC: 14783-007-01	30 g in 1 TUBE; 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	11/02/2016

Labeler - Ventura International LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-000, 14783-001, 14783-002, 14783-003, 14783-004, 14783-005, 14783-006, 14783-007)