ESIKA 3-IN-1 PRO MAKEUP FOUNDATION SPF 20- octinoxate, oxybenzone, and titanium dioxide powder 
Ventura Corporation (San Juan, P.R)

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ēsika
3-in-1 Pro Make Up
Foundation SPF 20

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).

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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 BOX05/17/201112/31/2021
1NDC:13537-329-016 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/17/201112/31/2021
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 BOX05/17/201112/31/2021
1NDC:13537-330-016 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/17/201112/31/2021
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 BOX05/17/201112/31/2021
1NDC:13537-331-016 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/17/201112/31/2021
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 BOX05/17/201112/31/2021
1NDC:13537-332-016 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/17/201112/31/2021
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 BOX05/17/201112/31/2021
1NDC:13537-333-016 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/17/201112/31/2021
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 BOX05/17/201112/31/2021
1NDC:13537-334-016 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/17/201112/31/2021
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 BOX05/17/201112/31/2021
1NDC:13537-335-016 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/17/201112/31/2021
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 BOX05/17/201112/31/2021
1NDC:13537-336-016 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/17/201112/31/2021
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
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)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
Product Characteristics
Colorred (Rosa 3) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-337-021 in 1 BOX05/17/201112/31/2021
1NDC:13537-337-016 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/17/201112/31/2021
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 BOX05/17/201112/31/2021
1NDC:13537-338-016 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/17/201112/31/2021
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 BOX05/17/201112/31/2021
1NDC:13537-339-016 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/17/201112/31/2021
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 BOX05/17/201112/31/2021
1NDC:13537-340-016 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/17/201112/31/2021
Labeler - Ventura Corporation (San Juan, P.R) (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(13537-329, 13537-330, 13537-331, 13537-332, 13537-333, 13537-334, 13537-335, 13537-336, 13537-337, 13537-338, 13537-339, 13537-340)

Revised: 5/2025
 
Ventura Corporation (San Juan, P.R)