Label: 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) - BROWN- octinoxate, titanium dioxide, and zinc oxide paste
LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (MEDIUM 6) - BROWN- octinoxate, titanium dioxide, and zinc oxide paste
LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (MEDIUM 7) - BROWN- octinoxate, titanium dioxide, and zinc oxide paste
LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (OBSCURE 8) - BROWN- octinoxate, titanium dioxide, and zinc oxide paste
LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (OBSCURE 9) - BROWN- octinoxate, titanium dioxide, and zinc oxide paste

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    14783-600-01, 14783-600-02, 14783-600-03, 14783-600-04, view more
    14783-601-05, 14783-601-06, 14783-601-07, 14783-601-08, 14783-602-09, 14783-602-10, 14783-602-11, 14783-602-12, 14783-603-13, 14783-603-14, 14783-603-15, 14783-603-16, 14783-604-17, 14783-604-18, 14783-604-19, 14783-604-20, 14783-605-21, 14783-605-22, 14783-605-23, 14783-605-24, 14783-606-25, 14783-606-26, 14783-606-27, 14783-606-28, 14783-607-29, 14783-607-30, 14783-607-31, 14783-607-32, 14783-608-29, 14783-608-30, 14783-608-31, 14783-608-32
  • Packager: Ventura International LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated May 23, 2014

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Octinoxate 6.5 %Sunscreen
    Titanium Dioxide 2.4%Sunscreen
    Zinc Oxide 1.5%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, MICROCRISTALLINA CERA (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, CANDELILLA CERA (EUPHORBIA CERIFERA (CANDELILLA) WAX), CERA ALBA (BEESWAX), CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA) WAX), POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, GLYCOSPHINGOLIPIDS, ALANYL GLUTAMINE.
    MAY CONTAIN: CI 77019 (MICA), CI 77891 (TITANIUM DIOXIDE), CI 77492 (IRON OXIDES), CI 77491 (IRON OXIDES), CI 77499 (IRON OXIDES).

  • SPL UNCLASSIFIED SECTION

    US: Distributed by Ventura International Ltd. DBA Belcorp USA, San Francisco, CA 94111.

  • PRINCIPAL DISPLAY PANEL - 30 g Bottle 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 Bottle Box - (CLAIRE 1) - BEIGE
  • PRINCIPAL DISPLAY PANEL - 30 g Bottle 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 Bottle Box - (CLAIRE 2) - BEIGE
  • PRINCIPAL DISPLAY PANEL - 30 g Bottle 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 Bottle Box - (CLAIRE 3) - BEIGE
  • PRINCIPAL DISPLAY PANEL - 30 g Bottle 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 Bottle Box - (CLAIRE 4) - BEIGE
  • PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - (MEDIUM 5) - BROWN

    L'BEL

    EFFET PARFAIT
    MINÉRAL

    natural skin effect
    mousse foundation
    SPF 16

    Net Wt. 1 oz. (30 g)

    Principal Display Panel - 30 g Bottle Box - (MEDIUM 5) - BROWN
  • PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - (MEDIUM 6) - BROWN

    L'BEL

    EFFET PARFAIT
    MINÉRAL

    natural skin effect
    mousse foundation
    SPF 16

    Net Wt. 1 oz. (30 g)

    Principal Display Panel - 30 g Bottle Box - (MEDIUM 6) - BROWN
  • PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - (MEDIUM 7) - BROWN

    L'BEL

    EFFET PARFAIT
    MINÉRAL

    natural skin effect
    mousse foundation
    SPF 16

    Net Wt. 1 oz. (30 g)

    Principal Display Panel - 30 g Bottle Box - (MEDIUM 7) - BROWN
  • PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - (OBSCURE 8) - BROWN

    L'BEL

    EFFET PARFAIT
    MINÉRAL

    natural skin effect
    mousse foundation
    SPF 16

    Net Wt. 1 oz. (30 g)

    Principal Display Panel - 30 g Bottle Box - (OBSCURE 8) - BROWN
  • PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - (OBSCURE 9) - BROWN

    L'BEL

    EFFET PARFAIT
    MINÉRAL

    natural skin effect
    mousse foundation
    SPF 16

    Net Wt. 1 oz. (30 g)

    Principal Display Panel - 30 g Bottle Box - (OBSCURE 9) - BROWN
  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-600
    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)  
    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)  
    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 YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-600-021 in 1 BOX
    1NDC:14783-600-0130 g in 1 BOTTLE
    2NDC:14783-600-041 in 1 BOX
    2NDC:14783-600-033 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/28/2014
    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:14783-601
    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)  
    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)  
    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 YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-601-061 in 1 BOX
    1NDC:14783-601-0530 g in 1 BOTTLE
    2NDC:14783-601-081 in 1 BOX
    2NDC:14783-601-073 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/28/2014
    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:14783-602
    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)  
    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)  
    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 YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-602-101 in 1 BOX
    1NDC:14783-602-0930 g in 1 BOTTLE
    2NDC:14783-602-121 in 1 BOX
    2NDC:14783-602-113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/28/2014
    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:14783-603
    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)  
    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)  
    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 YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-603-141 in 1 BOX
    1NDC:14783-603-1330 g in 1 BOTTLE
    2NDC:14783-603-161 in 1 BOX
    2NDC:14783-603-153 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/28/2014
    LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   (MEDIUM 5) - BROWN
    octinoxate, titanium dioxide, and zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-604
    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)  
    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)  
    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 YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-604-181 in 1 BOX
    1NDC:14783-604-1730 g in 1 BOTTLE
    2NDC:14783-604-201 in 1 BOX
    2NDC:14783-604-193 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/28/2014
    LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   (MEDIUM 6) - BROWN
    octinoxate, titanium dioxide, and zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-605
    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)  
    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)  
    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 YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-605-221 in 1 BOX
    1NDC:14783-605-2130 g in 1 BOTTLE
    2NDC:14783-605-241 in 1 BOX
    2NDC:14783-605-233 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/28/2014
    LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   (MEDIUM 7) - BROWN
    octinoxate, titanium dioxide, and zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-606
    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)  
    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)  
    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 YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-606-261 in 1 BOX
    1NDC:14783-606-2530 g in 1 BOTTLE
    2NDC:14783-606-281 in 1 BOX
    2NDC:14783-606-273 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/28/2014
    LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   (OBSCURE 8) - BROWN
    octinoxate, titanium dioxide, and zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-607
    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)  
    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)  
    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 YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-607-301 in 1 BOX
    1NDC:14783-607-2930 g in 1 BOTTLE
    2NDC:14783-607-321 in 1 BOX
    2NDC:14783-607-313 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/28/2014
    LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16   (OBSCURE 9) - BROWN
    octinoxate, titanium dioxide, and zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-608
    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)  
    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)  
    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 YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-608-301 in 1 BOX
    1NDC:14783-608-2930 g in 1 BOTTLE
    2NDC:14783-608-321 in 1 BOX
    2NDC:14783-608-313 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/28/2014
    Labeler - Ventura International LTD (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(14783-600, 14783-601, 14783-602, 14783-603, 14783-604, 14783-605, 14783-606, 14783-607, 14783-608)