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 
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.

----------

L'BEL EFFET PARFAIT MINÉRAL natural skin effect mousse foundation SPF 16

Drug Facts

Active IngredientsPurpose
OCTINOXATE 6.50 %Sunscreen
TITANIUM DIOXIDE 2.442 %Sunscreen
ZINC OXIDE 1.568 %Sunscreen

Uses

Warnings

  • 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

Other information

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.

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 1 - BEIGE

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 2 - BEIGE

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 3 - BEIGE

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 - CLAIRE 4 - BEIGE

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 5 - BEIGE

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 6 - BEIGE

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 - MEDIUM 7 - BEIGE

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)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - OBSCURE 8 - BEIGE
LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   CLAIRE 1 - BEIGE
octinoxate, titanium dioxide, and zinc oxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.024 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-000-021 in 1 BOX11/02/2016
1NDC:14783-000-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/02/2016
LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   CLAIRE 2 - BEIGE
octinoxate, titanium dioxide, and zinc oxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.024 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-001-021 in 1 BOX11/02/2016
1NDC:14783-001-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/02/2016
LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   CLAIRE 3 - BEIGE
octinoxate, titanium dioxide, and zinc oxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.024 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-002-021 in 1 BOX11/02/2016
1NDC:14783-002-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/02/2016
LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   CLAIRE 4 - BEIGE
octinoxate, titanium dioxide, and zinc oxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.024 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-003-021 in 1 BOX11/02/2016
1NDC:14783-003-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/02/2016
LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   MEDIUM 5 - BEIGE
octinoxate, titanium dioxide, and zinc oxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.024 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-004-021 in 1 BOX11/02/2016
1NDC:14783-004-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/02/2016
LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   MEDIUM 6 - BEIGE
octinoxate, titanium dioxide, and zinc oxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.024 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-005-021 in 1 BOX11/02/2016
1NDC:14783-005-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/02/2016
LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   MEDIUM 7 - BEIGE
octinoxate, titanium dioxide, and zinc oxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.024 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-006-021 in 1 BOX11/02/2016
1NDC:14783-006-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/02/2016
LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   OBSCURE 8 - BEIGE
octinoxate, titanium dioxide, and zinc oxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.024 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-007-021 in 1 BOX11/02/2016
1NDC:14783-007-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/02/2016
Labeler - Ventura International LTD (603192787)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(14783-000, 14783-001, 14783-002, 14783-003, 14783-004, 14783-005, 14783-006, 14783-007)

Revised: 11/2016
Document Id: 862def39-9cee-4c25-901f-8bb8ef25023a
Set id: 248e2147-201a-444b-a737-88d17f38e9fa
Version: 1
Effective Time: 20161104
 
Ventura International LTD