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 
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 MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16

Drug Facts

Active IngredientsPurpose
OCTINOXATE 6.50 %Sunscreen
TITANIUM DIOXIDE 2.4%Sunscreen
ZINC OXIDE 1.568%Sunscreen

Uses

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 damage 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

MOUSSE

matte finish 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

MOUSSE

matte finish 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

MOUSSE

matte finish 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

MOUSSE

matte finish 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

MOUSSE

matte finish 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

MOUSSE

matte finish 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

MOUSSE

matte finish 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 - BROWN

L'BEL

MOUSSE

matte finish mousse
foundation
SPF 16

Net Wt. 1 oz. (30 g)

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

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - OBSCURE 9 - BROWN

L'BEL

MOUSSE

matte finish mousse
foundation
SPF 16

Net Wt. 1 oz. (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - OBSCURE 9 - BROWN
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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-845
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)  
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:14783-845-021 in 1 BOX
1NDC:14783-845-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/20/2015
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 paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-846
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)  
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:14783-846-021 in 1 BOX
1NDC:14783-846-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/20/2015
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 paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-847
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)  
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:14783-847-021 in 1 BOX
1NDC:14783-847-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/20/2015
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 paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-848
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)  
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:14783-848-021 in 1 BOX
1NDC:14783-848-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/20/2015
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 paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-849
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)  
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:14783-849-021 in 1 BOX
1NDC:14783-849-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/20/2015
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 paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-850
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)  
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:14783-850-021 in 1 BOX
1NDC:14783-850-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/20/2015
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 paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-851
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)  
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:14783-851-021 in 1 BOX
1NDC:14783-851-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/20/2015
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 paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-852
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)  
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:14783-852-021 in 1 BOX
1NDC:14783-852-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/20/2015
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 paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-853
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)  
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:14783-853-021 in 1 BOX
1NDC:14783-853-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/20/2015
Labeler - Ventura International LTD (603192787)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(14783-845, 14783-846, 14783-847, 14783-848, 14783-849, 14783-850, 14783-851, 14783-852, 14783-853)

Revised: 11/2015
Document Id: 477837de-4654-4388-8fba-dda390f71f12
Set id: fa72e223-d463-4917-8554-f5925c5c7bf4
Version: 1
Effective Time: 20151119
 
Ventura International LTD