Label: LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 LATTE 180-F- octinoxate, zinc oxide emulsion
LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 CHAMPAGNE 170-N- octinoxate, zinc oxide emulsion
LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 ALMENDRA 230-N- octinoxate, zinc oxide emulsion
LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 BEIGE 220-C- octinoxate, zinc oxide emulsion
LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 CAPUCCINO 310-C- octinoxate, zinc oxide emulsion
LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 MOKACCINO 390-N- octinoxate, zinc oxide emulsion

  • NDC Code(s): 14141-017-01, 14141-018-01, 14141-019-01, 14141-020-01, view more
    14141-021-01, 14141-022-01
  • Packager: Bel Star S.A.
  • 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 December 2, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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  • Drug Facts

  • Active Ingredients

    OCTINOXATE 6.00%

    ZINC OXIDE 2.94%

  • Purpose

    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 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

    DIMETHICONE, ISODODECANE, WATER, MICA, GLYCERIN, TRIMETHYLSILOXYSILICATE, PEG-10 DIMETHICONE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, ALCOHOL DENAT., HYDROXYETHYL UREA, PEG/PPG-18/18 DIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SODIUM PCA, POLYSILICONE-11, SILICA, LECITHIN, PHENOXYETHANOL, SODIUM CHLORIDE, NIACINAMIDE, SILICA DIMETHYL SILYLATE, TRIETHOXYCAPRYLYLSILANE, CAPRYLYL GLYCOL, DISTEARDIMONIUM HECTORITE, CHLORPHENESIN, FRAGRANCE, PANTHENOL, TOCOPHERYL ACETATE, SACCHAROMYCES LYSATE, PERFLUOROHEXYLETHYL TRIETHOXYSILANE, DISODIUM SUCCINATE, GLUTAMIC ACID, GLYCINE, THREONINE, VALINE. MAY CONTAIN: TITANIUM DIOXIDE, IRON OXIDES.

  • Company Information

    U.S.A.: Dist. by Ventura Int Ltd. DBA Belcorp USA Miami, FL 33126

    PUERTO RICO: Dist. by Ventura Corp. Ltd., San Juan, Puerto Rico 00926.

    Made in Columbia.

    www.lbel.com

  • Product Packaging ALMENDRA 230-N

    230-N

  • Product Packaging BEIGE 220-C

    220-C

  • Product Packaging CAPUCCINO 310-C

    310-C

  • Product Packaging CHAMPAGNE 170-N

    170-N

  • Product Packaging LATTE 180-F

    180-F

  • Product Packaging MOKACCINO 390-N

    390-N

  • INGREDIENTS AND APPEARANCE
    LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 LATTE 180-F 
    octinoxate, zinc oxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE29.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    THREONINE (UNII: 2ZD004190S)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    VALINE (UNII: HG18B9YRS7)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    GLYCINE (UNII: TE7660XO1C)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISODODECANE (UNII: A8289P68Y2)  
    MICA (UNII: V8A1AW0880)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-021-011 in 1 BOX01/19/2022
    126 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/19/2022
    LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 CHAMPAGNE 170-N 
    octinoxate, zinc oxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE29.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    THREONINE (UNII: 2ZD004190S)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    VALINE (UNII: HG18B9YRS7)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    GLYCINE (UNII: TE7660XO1C)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISODODECANE (UNII: A8289P68Y2)  
    MICA (UNII: V8A1AW0880)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-020-011 in 1 BOX01/19/2022
    126 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/19/2022
    LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 ALMENDRA 230-N 
    octinoxate, zinc oxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE29.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    THREONINE (UNII: 2ZD004190S)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    VALINE (UNII: HG18B9YRS7)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    GLYCINE (UNII: TE7660XO1C)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISODODECANE (UNII: A8289P68Y2)  
    MICA (UNII: V8A1AW0880)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-017-011 in 1 BOX01/19/2022
    126 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/19/2022
    LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 BEIGE 220-C 
    octinoxate, zinc oxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE29.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    THREONINE (UNII: 2ZD004190S)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    VALINE (UNII: HG18B9YRS7)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    GLYCINE (UNII: TE7660XO1C)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISODODECANE (UNII: A8289P68Y2)  
    MICA (UNII: V8A1AW0880)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-018-011 in 1 BOX01/19/2022
    126 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/19/2022
    LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 CAPUCCINO 310-C 
    octinoxate, zinc oxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE29.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    THREONINE (UNII: 2ZD004190S)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    VALINE (UNII: HG18B9YRS7)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    GLYCINE (UNII: TE7660XO1C)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISODODECANE (UNII: A8289P68Y2)  
    MICA (UNII: V8A1AW0880)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-019-011 in 1 BOX01/19/2022
    126 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/19/2022
    LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 MOKACCINO 390-N 
    octinoxate, zinc oxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE29.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    THREONINE (UNII: 2ZD004190S)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    VALINE (UNII: HG18B9YRS7)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    GLYCINE (UNII: TE7660XO1C)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISODODECANE (UNII: A8289P68Y2)  
    MICA (UNII: V8A1AW0880)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-022-011 in 1 BOX01/19/2022
    126 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/19/2022
    Labeler - Bel Star S.A. (880160197)
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