Label: LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 MEDIUM 7- octinoxate, titanium dioxide, zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 OBSCURE 8- octinoxate, titanium dioxide, zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 OBSCURE 9- octinoxate, titanium dioxide, zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 1- octinoxate, titanium dioxide, zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 2- octinoxate, titanium dioxide, zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 3- octinoxate, titanium dioxide, zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 4- octinoxate, titanium dioxide, zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 MEDIUM 5- octinoxate, titanium dioxide, zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 MEDIUM 6- octinoxate, titanium dioxide, zinc oxide paste

  • 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 19, 2020

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

  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Octinoxate 6.50% Sunscreen

    Titanium 2.44% Sunscreen

    Zinc Oxide 1.57% Sunscreen

  • PURPOSE

    • Helps prevent sunburn.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • INDICATIONS & USAGE

    • Stop use and ask a doctorif rash occurs.
  • 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.

  • DOSAGE & ADMINISTRATION

    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
  • INACTIVE INGREDIENT

    Cylcopentasiloxane, Mica, Dimethicone Crosspolymer, dimethicone/vinyl dimethicone crosspolymer, trimethylsiloxysilicate, cyclohexasiloxane, bis-hydroxyethoxypropyl dimethicone, octyldodecanol, phenoxyethanol, boron nitride, irvingia gabonensis kernel butter, disteardimonium hectorite, alumina, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, silica, hydrogenated coco-glycerides, hexyl laurate, dimethiconol, caprylyl glycol, tocopheryl acetate, chlorphenesin, lauroyl lysine, propylene carbonate, hydrogen dimethicone, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, rhodiola rosea root extract, carnosine, triethoxycaprylylsilane. May Contain: titanium dioxide , iron oxides

  • OTHER SAFETY INFORMATION

    Other Information

    Protect the product in this container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL

    L'BEL

    Mousse Mattifiant

    Base textura mousse acabado mate FPS 15

    Matte finish mousse foundation SPF 15

    Base textura mousse acabamento mate FPS 15

    Tone: Claire 1

    Net wt 1 oz. (30 g)

    CJ-51807-E CLAIRE 1

  • PRINCIPAL DISPLAY PANEL

    L'BEL
    Mousse Mattifiant
    Base textura mousse acabado mate FPS 15
    Matte finish mousse foundation SPF 15
    Base textura mousse acabamento mate FPS 15
    Tone: Claire 2
    Net wt 1 oz. (30 g)

    CJ-51807-E Claire 2

  • PRINCIPAL DISPLAY PANEL

    L'BEL
    Mousse Mattifiant
    Base textura mousse acabado mate FPS 15
    Matte finish mousse foundation SPF 15
    Base textura mousse acabamento mate FPS 15
    Tone: Claire 3
    Net wt 1 oz. (30 g)

    CJ-51807-E Claire 3

  • PRINCIPAL DISPLAY PANEL

    L'BEL
    Mousse Mattifiant
    Base textura mousse acabado mate FPS 15
    Matte finish mousse foundation SPF 15
    Base textura mousse acabamento mate FPS 15
    Tone: Claire 4
    Net wt 1 oz. (30 g)

    CJ-51807-E Claire 4

  • PRINCIPAL DISPLAY PANEL

    L'BEL
    Mousse Mattifiant
    Base textura mousse acabado mate FPS 15
    Matte finish mousse foundation SPF 15
    Base textura mousse acabamento mate FPS 15
    Tone: Medium 5
    Net wt 1 oz. (30 g)

    CJ-51807-E Medium 5

  • PRINCIPAL DISPLAY PANEL

    L'BEL
    Mousse Mattifiant
    Base textura mousse acabado mate FPS 15
    Matte finish mousse foundation SPF 15
    Base textura mousse acabamento mate FPS 15
    Tone: Medium 6
    Net wt 1 oz. (30 g)

    CJ-51807-E Medium 6

  • PRINCIPAL DISPLAY PANEL

    L'BEL
    Mousse Mattifiant
    Base textura mousse acabado mate FPS 15
    Matte finish mousse foundation SPF 15
    Base textura mousse acabamento mate FPS 15
    Tone: Medium 7
    Net wt 1 oz. (30 g)

    CJ-51807-E Medium 7

  • PRINCIPAL DISPLAY PANEL

    L'BEL
    Mousse Mattifiant
    Base textura mousse acabado mate FPS 15
    Matte finish mousse foundation SPF 15
    Base textura mousse acabamento mate FPS 15
    Tone: Obscure 8
    Net wt 1 oz. (30 g)

    CJ-51807-E Obscure8

  • PRINCIPAL DISPLAY PANEL

    L'BEL
    Mousse Mattifiant
    Base textura mousse acabado mate FPS 15
    Matte finish mousse foundation SPF 15
    Base textura mousse acabamento mate FPS 15
    Tone: Obscure 9
    Net wt 1 oz. (30 g)

    CJ-51807-E obscure

  • INGREDIENTS AND APPEARANCE
    LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 MEDIUM 7 
    octinoxate, titanium dioxide, zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0174
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.44 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.57 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V)  
    BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)  
    IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALANYL GLUTAMINE (UNII: U5JDO2770Z)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0174-130 g in 1 TUBE; Type 0: Not a Combination Product11/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/12/2020
    LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 OBSCURE 8 
    octinoxate, titanium dioxide, zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0175
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.44 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.57 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V)  
    BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)  
    IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALANYL GLUTAMINE (UNII: U5JDO2770Z)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0175-130 g in 1 TUBE; Type 0: Not a Combination Product11/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/12/2020
    LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 OBSCURE 9 
    octinoxate, titanium dioxide, zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0176
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.44 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.57 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V)  
    BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)  
    IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALANYL GLUTAMINE (UNII: U5JDO2770Z)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0176-130 g in 1 TUBE; Type 0: Not a Combination Product11/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/12/2020
    LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 1 
    octinoxate, titanium dioxide, zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0177
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.44 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.57 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V)  
    BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)  
    IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALANYL GLUTAMINE (UNII: U5JDO2770Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0177-130 g in 1 TUBE; Type 0: Not a Combination Product11/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/12/2020
    LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 2 
    octinoxate, titanium dioxide, zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0178
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.44 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.57 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V)  
    BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)  
    IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALANYL GLUTAMINE (UNII: U5JDO2770Z)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0178-130 g in 1 TUBE; Type 0: Not a Combination Product11/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/12/2020
    LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 3 
    octinoxate, titanium dioxide, zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0179
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.44 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.57 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V)  
    BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)  
    IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALANYL GLUTAMINE (UNII: U5JDO2770Z)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0179-130 g in 1 TUBE; Type 0: Not a Combination Product11/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/12/2020
    LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 4 
    octinoxate, titanium dioxide, zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0180
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.44 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.57 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V)  
    BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)  
    IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALANYL GLUTAMINE (UNII: U5JDO2770Z)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0180-130 g in 1 TUBE; Type 0: Not a Combination Product11/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/12/2020
    LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 MEDIUM 5 
    octinoxate, titanium dioxide, zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0181
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.44 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.57 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V)  
    BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)  
    IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALANYL GLUTAMINE (UNII: U5JDO2770Z)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0181-130 g in 1 TUBE; Type 0: Not a Combination Product11/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/12/2020
    LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 MEDIUM 6 
    octinoxate, titanium dioxide, zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0182
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.44 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.57 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V)  
    BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)  
    IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALANYL GLUTAMINE (UNII: U5JDO2770Z)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0182-130 g in 1 TUBE; Type 0: Not a Combination Product11/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/12/2020
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197manufacture(43596-0174, 43596-0175, 43596-0176, 43596-0177, 43596-0178, 43596-0179, 43596-0180, 43596-0181, 43596-0182)