Label: ESIKA- octinoxate, oxybenzone, and titanium dioxide powder

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    13537-329-01, 13537-329-02, 13537-330-01, 13537-330-02, view more
    13537-331-01, 13537-331-02, 13537-332-01, 13537-332-02, 13537-333-01, 13537-333-02, 13537-334-01, 13537-334-02, 13537-335-01, 13537-335-02, 13537-336-01, 13537-336-02, 13537-337-01, 13537-337-02, 13537-338-01, 13537-338-02, 13537-339-01, 13537-339-02, 13537-340-01, 13537-340-02
  • Packager: Ventura Corporation (San Juan, P.R)
  • 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 May 18, 2011

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Octinoxate (7%), Oxybenzone (2%), Titanium Dioxide (2%)

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • provides moderate protection against sunburn
  • Warnings

    • For external use only.

    • When using this product keep out of eyes. Rinse with water to remove.

    • Stop use and ask a doctor if rash and irritation develops and lasts.

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

    • apply smootly every morning before sun exposure and as needed.
    • apply evenly on face and neck using a latex pad. Touch up when necessary.
    • moderate sun protection product.
  • Other information

    • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.
  • Inactive ingredients

    Isostearyl neopentanoate, C12-15 alkyl benzoate, polymethyl methacrylate, corn starch, silica, mica, ethylhexyl palmitate, ozokerite, copernicia cerifera cera (copernicia cerifera (carnauba) wax), phenoxyethanol, octyldodecanol, trimethylsiloxysilicate, dimethicone, methylparaben, tocopheryl acetate, microcrystalline wax, propylparaben, petrolatum, phospholipids, bht, c9-13 fluoroalcohol, butylparaben, ethylparaben, phosphoric acid, cholesterol, isobutylparaben, candelilla cera (euphorbia cerifera (candelilla) wax), cera alba (beeswax), cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, glycosphingolipids, chitosan, ci 77492 (iron oxides), ci 77491 (iron oxides), ci 77499 (iron oxides).

  • PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 1

    ēsika

    3-in-1 Pro Make Up
    Foundation SPF 20

    6 g e (.21 oz.)

    PRINCIPAL DISPLAY PANEL - 6 g Carton
  • PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 2

    ēsika

    3-in-1 Pro Make Up
    Foundation SPF 20

    6 g e (.21 oz.)

    PRINCIPAL DISPLAY PANEL - 6 g Carton
  • PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 3

    ēsika

    3-in-1 Pro Make Up
    Foundation SPF 20

    6 g e (.21 oz.)

    PRINCIPAL DISPLAY PANEL - 6 g Carton
  • PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 4

    ēsika

    3-in-1 Pro Make Up
    Foundation SPF 20

    6 g e (.21 oz.)

    PRINCIPAL DISPLAY PANEL - 6 g Carton
  • PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 5

    ēsika

    3-in-1 Pro Make Up
    Foundation SPF 20

    6 g e (.21 oz.)

    PRINCIPAL DISPLAY PANEL - 6 g Carton
  • PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 6

    ēsika

    3-in-1 Pro Make Up
    Foundation SPF 20

    6 g e (.21 oz.)

    PRINCIPAL DISPLAY PANEL - 6 g Carton
  • PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 1

    ēsika

    3-in-1 Pro Make Up
    Foundation SPF 20

    6 g e (.21 oz.)

    PRINCIPAL DISPLAY PANEL - 6 g Carton
  • PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 2

    ēsika

    3-in-1 Pro Make Up
    Foundation SPF 20

    6 g e (.21 oz.)

    PRINCIPAL DISPLAY PANEL - 6 g Carton
  • PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 3

    ēsika

    3-in-1 Pro Make Up
    Foundation SPF 20

    6 g e (.21 oz.)

    PRINCIPAL DISPLAY PANEL - 6 g Carton
  • PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 4

    ēsika

    3-in-1 Pro Make Up
    Foundation SPF 20

    6 g e (.21 oz.)

    PRINCIPAL DISPLAY PANEL - 6 g Carton
  • PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 5

    ēsika

    3-in-1 Pro Make Up
    Foundation SPF 20

    6 g e (.21 oz.)

    PRINCIPAL DISPLAY PANEL - 6 g Carton
  • PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 6

    ēsika

    3-in-1 Pro Make Up
    Foundation SPF 20

    6 g e (.21 oz.)

    PRINCIPAL DISPLAY PANEL - 6 g Carton
  • INGREDIENTS AND APPEARANCE
    ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
    octinoxate, oxybenzone, and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-329
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    starch, corn (UNII: O8232NY3SJ)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    mica (UNII: V8A1AW0880)  
    ethylhexyl palmitate (UNII: 2865993309)  
    ceresin (UNII: Q1LS2UJO3A)  
    carnauba wax (UNII: R12CBM0EIZ)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    octyldodecanol (UNII: 461N1O614Y)  
    dimethicone (UNII: 92RU3N3Y1O)  
    methylparaben (UNII: A2I8C7HI9T)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    propylparaben (UNII: Z8IX2SC1OH)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    phosphoric acid (UNII: E4GA8884NN)  
    cholesterol (UNII: 97C5T2UQ7J)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Product Characteristics
    ColorBROWN (Beige 1) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-329-021 in 1 BOX
    1NDC:13537-329-016 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/17/2011
    ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
    octinoxate, oxybenzone, and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-330
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    starch, corn (UNII: O8232NY3SJ)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    mica (UNII: V8A1AW0880)  
    ethylhexyl palmitate (UNII: 2865993309)  
    ceresin (UNII: Q1LS2UJO3A)  
    carnauba wax (UNII: R12CBM0EIZ)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    octyldodecanol (UNII: 461N1O614Y)  
    dimethicone (UNII: 92RU3N3Y1O)  
    methylparaben (UNII: A2I8C7HI9T)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    propylparaben (UNII: Z8IX2SC1OH)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    phosphoric acid (UNII: E4GA8884NN)  
    cholesterol (UNII: 97C5T2UQ7J)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Product Characteristics
    ColorBROWN (Beige 2) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-330-021 in 1 BOX
    1NDC:13537-330-016 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/17/2011
    ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
    octinoxate, oxybenzone, and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-331
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    starch, corn (UNII: O8232NY3SJ)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    mica (UNII: V8A1AW0880)  
    ethylhexyl palmitate (UNII: 2865993309)  
    ceresin (UNII: Q1LS2UJO3A)  
    carnauba wax (UNII: R12CBM0EIZ)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    octyldodecanol (UNII: 461N1O614Y)  
    dimethicone (UNII: 92RU3N3Y1O)  
    methylparaben (UNII: A2I8C7HI9T)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    propylparaben (UNII: Z8IX2SC1OH)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    phosphoric acid (UNII: E4GA8884NN)  
    cholesterol (UNII: 97C5T2UQ7J)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Product Characteristics
    ColorBROWN (Beige 3) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-331-021 in 1 BOX
    1NDC:13537-331-016 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/17/2011
    ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
    octinoxate, oxybenzone, and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    starch, corn (UNII: O8232NY3SJ)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    mica (UNII: V8A1AW0880)  
    ethylhexyl palmitate (UNII: 2865993309)  
    ceresin (UNII: Q1LS2UJO3A)  
    carnauba wax (UNII: R12CBM0EIZ)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    octyldodecanol (UNII: 461N1O614Y)  
    dimethicone (UNII: 92RU3N3Y1O)  
    methylparaben (UNII: A2I8C7HI9T)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    propylparaben (UNII: Z8IX2SC1OH)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    phosphoric acid (UNII: E4GA8884NN)  
    cholesterol (UNII: 97C5T2UQ7J)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Product Characteristics
    ColorBROWN (Beige 4) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-332-021 in 1 BOX
    1NDC:13537-332-016 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/17/2011
    ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
    octinoxate, oxybenzone, and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    starch, corn (UNII: O8232NY3SJ)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    mica (UNII: V8A1AW0880)  
    ethylhexyl palmitate (UNII: 2865993309)  
    ceresin (UNII: Q1LS2UJO3A)  
    carnauba wax (UNII: R12CBM0EIZ)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    octyldodecanol (UNII: 461N1O614Y)  
    dimethicone (UNII: 92RU3N3Y1O)  
    methylparaben (UNII: A2I8C7HI9T)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    propylparaben (UNII: Z8IX2SC1OH)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    phosphoric acid (UNII: E4GA8884NN)  
    cholesterol (UNII: 97C5T2UQ7J)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Product Characteristics
    ColorBROWN (Beige 5) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-333-021 in 1 BOX
    1NDC:13537-333-016 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/17/2011
    ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
    octinoxate, oxybenzone, and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-334
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    starch, corn (UNII: O8232NY3SJ)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    mica (UNII: V8A1AW0880)  
    ethylhexyl palmitate (UNII: 2865993309)  
    ceresin (UNII: Q1LS2UJO3A)  
    carnauba wax (UNII: R12CBM0EIZ)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    octyldodecanol (UNII: 461N1O614Y)  
    dimethicone (UNII: 92RU3N3Y1O)  
    methylparaben (UNII: A2I8C7HI9T)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    propylparaben (UNII: Z8IX2SC1OH)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    phosphoric acid (UNII: E4GA8884NN)  
    cholesterol (UNII: 97C5T2UQ7J)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Product Characteristics
    ColorBROWN (Beige 6) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-334-021 in 1 BOX
    1NDC:13537-334-016 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/17/2011
    ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
    octinoxate, oxybenzone, and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-335
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    starch, corn (UNII: O8232NY3SJ)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    mica (UNII: V8A1AW0880)  
    ethylhexyl palmitate (UNII: 2865993309)  
    ceresin (UNII: Q1LS2UJO3A)  
    carnauba wax (UNII: R12CBM0EIZ)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    octyldodecanol (UNII: 461N1O614Y)  
    dimethicone (UNII: 92RU3N3Y1O)  
    methylparaben (UNII: A2I8C7HI9T)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    propylparaben (UNII: Z8IX2SC1OH)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    phosphoric acid (UNII: E4GA8884NN)  
    cholesterol (UNII: 97C5T2UQ7J)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Product Characteristics
    ColorRED (Rosa 1) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-335-021 in 1 BOX
    1NDC:13537-335-016 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/17/2011
    ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
    octinoxate, oxybenzone, and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-336
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    starch, corn (UNII: O8232NY3SJ)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    mica (UNII: V8A1AW0880)  
    ethylhexyl palmitate (UNII: 2865993309)  
    ceresin (UNII: Q1LS2UJO3A)  
    carnauba wax (UNII: R12CBM0EIZ)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    octyldodecanol (UNII: 461N1O614Y)  
    dimethicone (UNII: 92RU3N3Y1O)  
    methylparaben (UNII: A2I8C7HI9T)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    propylparaben (UNII: Z8IX2SC1OH)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    phosphoric acid (UNII: E4GA8884NN)  
    cholesterol (UNII: 97C5T2UQ7J)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Product Characteristics
    ColorRED (Rosa 2) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-336-021 in 1 BOX
    1NDC:13537-336-016 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/17/2011
    ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
    octinoxate, oxybenzone, and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-337
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    starch, corn (UNII: O8232NY3SJ)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    mica (UNII: V8A1AW0880)  
    ethylhexyl palmitate (UNII: 2865993309)  
    ceresin (UNII: Q1LS2UJO3A)  
    carnauba wax (UNII: R12CBM0EIZ)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    octyldodecanol (UNII: 461N1O614Y)  
    dimethicone (UNII: 92RU3N3Y1O)  
    methylparaben (UNII: A2I8C7HI9T)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    propylparaben (UNII: Z8IX2SC1OH)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    phosphoric acid (UNII: E4GA8884NN)  
    cholesterol (UNII: 97C5T2UQ7J)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Product Characteristics
    ColorRED (Rosa 3) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-337-021 in 1 BOX
    1NDC:13537-337-016 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/17/2011
    ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
    octinoxate, oxybenzone, and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-338
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    starch, corn (UNII: O8232NY3SJ)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    mica (UNII: V8A1AW0880)  
    ethylhexyl palmitate (UNII: 2865993309)  
    ceresin (UNII: Q1LS2UJO3A)  
    carnauba wax (UNII: R12CBM0EIZ)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    octyldodecanol (UNII: 461N1O614Y)  
    dimethicone (UNII: 92RU3N3Y1O)  
    methylparaben (UNII: A2I8C7HI9T)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    propylparaben (UNII: Z8IX2SC1OH)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    phosphoric acid (UNII: E4GA8884NN)  
    cholesterol (UNII: 97C5T2UQ7J)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Product Characteristics
    ColorRED (Rosa 4) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-338-021 in 1 BOX
    1NDC:13537-338-016 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/17/2011
    ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
    octinoxate, oxybenzone, and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-339
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    starch, corn (UNII: O8232NY3SJ)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    mica (UNII: V8A1AW0880)  
    ethylhexyl palmitate (UNII: 2865993309)  
    ceresin (UNII: Q1LS2UJO3A)  
    carnauba wax (UNII: R12CBM0EIZ)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    octyldodecanol (UNII: 461N1O614Y)  
    dimethicone (UNII: 92RU3N3Y1O)  
    methylparaben (UNII: A2I8C7HI9T)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    propylparaben (UNII: Z8IX2SC1OH)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    phosphoric acid (UNII: E4GA8884NN)  
    cholesterol (UNII: 97C5T2UQ7J)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Product Characteristics
    ColorRED (Rosa 5) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-339-021 in 1 BOX
    1NDC:13537-339-016 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/17/2011
    ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
    octinoxate, oxybenzone, and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-340
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    starch, corn (UNII: O8232NY3SJ)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    mica (UNII: V8A1AW0880)  
    ethylhexyl palmitate (UNII: 2865993309)  
    ceresin (UNII: Q1LS2UJO3A)  
    carnauba wax (UNII: R12CBM0EIZ)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    octyldodecanol (UNII: 461N1O614Y)  
    dimethicone (UNII: 92RU3N3Y1O)  
    methylparaben (UNII: A2I8C7HI9T)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    propylparaben (UNII: Z8IX2SC1OH)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    phosphoric acid (UNII: E4GA8884NN)  
    cholesterol (UNII: 97C5T2UQ7J)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Product Characteristics
    ColorRED (Rosa 6) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-340-021 in 1 BOX
    1NDC:13537-340-016 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/17/2011
    Labeler - Ventura Corporation (San Juan, P.R) (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE