Label: LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 CLAIRE 1 - BEIGE- octinoxate, titanium dioxide, and zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 CLAIRE 2 - BEIGE- octinoxate, titanium dioxide, and zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 CLAIRE 3 - BEIGE- octinoxate, titanium dioxide, and zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 CLAIRE 4 - BEIGE- octinoxate, titanium dioxide, and zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 MEDIUM 5 - BEIGE- octinoxate, titanium dioxide, and zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 MEDIUM 6 - BEIGE- octinoxate, titanium dioxide, and zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 MEDIUM 7 - BEIGE- octinoxate, titanium dioxide, and zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 OBSCURE 8 - BROWN- octinoxate, titanium dioxide, and zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 OBSCURE 9 - BROWN- octinoxate, titanium dioxide, and zinc oxide paste
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-845-01, 14783-845-02, 14783-846-01, 14783-846-02, view more14783-847-01, 14783-847-02, 14783-848-01, 14783-848-02, 14783-849-01, 14783-849-02, 14783-850-01, 14783-850-02, 14783-851-01, 14783-851-02, 14783-852-01, 14783-852-02, 14783-853-01, 14783-853-02 - Packager: Ventura International LTD
- Category: HUMAN OTC DRUG LABEL
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 19, 2015
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
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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
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLAIRE 1 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLAIRE 2 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLAIRE 3 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLAIRE 4 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIUM 5 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIUM 6 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIUM 7 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - OBSCURE 8 - BROWN
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - OBSCURE 9 - BROWN
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INGREDIENTS AND APPEARANCE
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 CLAIRE 1 - BEIGE
octinoxate, titanium dioxide, and zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-845 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) 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) 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:14783-845-02 1 in 1 BOX 1 NDC:14783-845-01 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 11/20/2015 LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 CLAIRE 2 - BEIGE
octinoxate, titanium dioxide, and zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-846 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) 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) 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:14783-846-02 1 in 1 BOX 1 NDC:14783-846-01 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 11/20/2015 LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 CLAIRE 3 - BEIGE
octinoxate, titanium dioxide, and zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-847 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) 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) 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:14783-847-02 1 in 1 BOX 1 NDC:14783-847-01 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 11/20/2015 LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 CLAIRE 4 - BEIGE
octinoxate, titanium dioxide, and zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-848 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) 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) 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:14783-848-02 1 in 1 BOX 1 NDC:14783-848-01 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 11/20/2015 LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 MEDIUM 5 - BEIGE
octinoxate, titanium dioxide, and zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-849 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) 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) 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:14783-849-02 1 in 1 BOX 1 NDC:14783-849-01 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 11/20/2015 LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 MEDIUM 6 - BEIGE
octinoxate, titanium dioxide, and zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-850 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) 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) 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:14783-850-02 1 in 1 BOX 1 NDC:14783-850-01 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 11/20/2015 LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 MEDIUM 7 - BEIGE
octinoxate, titanium dioxide, and zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-851 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) 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) 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:14783-851-02 1 in 1 BOX 1 NDC:14783-851-01 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 11/20/2015 LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 OBSCURE 8 - BROWN
octinoxate, titanium dioxide, and zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-852 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) 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) 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:14783-852-02 1 in 1 BOX 1 NDC:14783-852-01 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 11/20/2015 LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 OBSCURE 9 - BROWN
octinoxate, titanium dioxide, and zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-853 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) 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) 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:14783-853-02 1 in 1 BOX 1 NDC:14783-853-01 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 11/20/2015 Labeler - Ventura International LTD (603192787) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(14783-845, 14783-846, 14783-847, 14783-848, 14783-849, 14783-850, 14783-851, 14783-852, 14783-853)