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 - 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

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    14783-000-01, 14783-000-02, 14783-001-01, 14783-001-02, view more
    14783-002-01, 14783-002-02, 14783-003-01, 14783-003-02, 14783-004-01, 14783-004-02, 14783-005-01, 14783-005-02, 14783-006-01, 14783-006-02, 14783-007-01, 14783-007-02
  • 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 November 4, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    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 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
  • 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:14783-000
    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)