ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 1) - ROSE- octinoxate, oxybenzone, and titanium dioxide cream 
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 2) - ROSE- octinoxate, oxybenzone, and titanium dioxide cream 
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 3) - ROSE- octinoxate, oxybenzone, and titanium dioxide cream 
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 4) - ROSE- octinoxate, oxybenzone, and titanium dioxide cream 
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 5) - ROSE- octinoxate, oxybenzone, and titanium dioxide cream 
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 6) - ROSE- octinoxate, oxybenzone, and titanium dioxide cream 
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 1) - BEIGE- octinoxate, oxybenzone, and titanium dioxide cream 
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 2) - BEIGE- octinoxate, oxybenzone, and titanium dioxide cream 
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 3) - BEIGE- octinoxate, oxybenzone, and titanium dioxide cream 
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 4) - BEIGE- octinoxate, oxybenzone, and titanium dioxide cream 
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 5) - BEIGE- octinoxate, oxybenzone, and titanium dioxide cream 
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 6) - BEIGE- octinoxate, oxybenzone, and titanium dioxide cream 
Ventura Corporation LTD

----------

ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20

Drug Facts

Active Ingredients

OCTINOXATE 7.0 %,OXYBENZONE 2.0%, TITANIUM DIOXIDE 2.0%

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, notskin cancer or early skin aging.
  • For external use only.

  • Do not useon damage or broken skin.

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

  • Stop use and ask a doctor ifrash 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.
  • Children under 6 months of age: Ask a doctor.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.

Other information

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

Inactive Ingredients

ISOSTEARYL NEOPENTANOATE, C12-15 ALKYL BENZOATE,POLYMETHYL METHACRYLATE, ZEA MAYS STARCH (ZEA MAYS (CORN) STARCH), SILICA, MICA, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL PALMITATE, OZOKERITE, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA) WAX), BENZOPHENONE-3, TITANIUM DIOXIDE, PHENOXYETHANOL, OCTYLDODECANOL, TRIMETHYLSILOXYSILICATE, DIMETHICONE, METHYLPARABEN, TOCOPHERYL ACETATE, MICROCRISTALLINA CERA (MICROCRYSTALLINE WAX), PROPYLPARABEN, PETROLATUM, PHOSPHOLIPIDS, BHT, C9-13 FLUOROALCOHOL, BUTYLPARABEN, ETHYLPARABEN, PHOSPHORIC ACID, CHOLESTEROL, ISOBUTYLPARABEN, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, CANDELILLA CERA (EUPHORBIA CERIFERA (CANDELILLA) WAX), CERA ALBA (BEESWAX), CETEARYL GLUCOSIDE, CETEARYL ALCOHOL, GLYCOSPHINGOLIPIDS. May contain:CI 77491 (IRON OXIDES), CI 77492 (IRON OXIDES), CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE ), CHITOSAN.

P.R.:Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 1) - ROSE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e(.21 oz.)

Principal Display Panel - 6 g Bottle Box - (ROSE 1) - ROSE

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 2) - ROSE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e(.21 oz.)

Principal Display Panel - 6 g Bottle Box - (ROSE 2) - ROSE

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 3) - ROSE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e(.21 oz.)

Principal Display Panel - 6 g Bottle Box - (ROSE 3) - ROSE

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 4) - ROSE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e(.21 oz.)

Principal Display Panel - 6 g Bottle Box - (ROSE 4) - ROSE

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 5) - ROSE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e(.21 oz.)

Principal Display Panel - 6 g Bottle Box - (ROSE 5) - ROSE

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box (ROSE 6) - ROSE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e(.21 oz.)

Principal Display Panel - 6 g Bottle Box - (ROSE 6) - ROSE

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 1) - BEIGE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e(.21 oz.)

Principal Display Panel - 6 g Bottle Box - (BEIGE 1) - BEIGE

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 2) - BEIGE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e(.21 oz.)

Principal Display Panel - 6 g Bottle Box - (BEIGE 2) - BEIGE

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 3) - BEIGE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e(.21 oz.)

Principal Display Panel - 6 g Bottle Box - (BEIGE 3) - BEIGE

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 4) - BEIGE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e(.21 oz.)

Principal Display Panel - 6 g Bottle Box - (BEIGE 4) - BEIGE

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 5) - BEIGE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e(.21 oz.)

Principal Display Panel - 6 g Bottle Box - (BEIGE 5) - BEIGE

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 6) - BEIGE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e(.21 oz.)

Principal Display Panel - 6 g Bottle Box - (BEIGE 6) - BEIGE
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20  (ROSE 1) - ROSE
octinoxate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-198
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
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)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-198-021 in 1 BOX03/06/201412/31/2021
1NDC:13537-198-016 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201412/31/2021
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20  (ROSE 2) - ROSE
octinoxate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-197
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
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)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-197-041 in 1 BOX03/06/201412/31/2021
1NDC:13537-197-036 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201412/31/2021
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20  (ROSE 3) - ROSE
octinoxate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-196
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
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)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-196-061 in 1 BOX03/06/201412/31/2021
1NDC:13537-196-056 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201412/31/2021
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20  (ROSE 4) - ROSE
octinoxate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-195
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
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)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-195-081 in 1 BOX03/06/201412/31/2021
1NDC:13537-195-076 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201412/31/2021
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20  (ROSE 5) - ROSE
octinoxate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-194
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
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)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-194-101 in 1 BOX03/06/201412/31/2021
1NDC:13537-194-096 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201412/31/2021
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20  (ROSE 6) - ROSE
octinoxate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-193
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
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)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-193-121 in 1 BOX03/06/201412/31/2021
1NDC:13537-193-116 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201412/31/2021
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20  (BEIGE 1) - BEIGE
octinoxate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-192
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
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)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-192-141 in 1 BOX03/06/201412/31/2021
1NDC:13537-192-136 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201412/31/2021
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20  (BEIGE 2) - BEIGE
octinoxate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-191
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
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)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-191-161 in 1 BOX03/06/201412/31/2021
1NDC:13537-191-156 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201412/31/2021
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20  (BEIGE 3) - BEIGE
octinoxate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-190
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
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)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-190-181 in 1 BOX03/06/201412/31/2021
1NDC:13537-190-176 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201412/31/2021
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20  (BEIGE 4) - BEIGE
octinoxate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-189
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
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)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-189-201 in 1 BOX03/06/201412/31/2021
1NDC:13537-189-196 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201412/31/2021
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20  (BEIGE 5) - BEIGE
octinoxate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-188
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
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)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-188-221 in 1 BOX03/06/201412/31/2021
1NDC:13537-188-216 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201412/31/2021
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20  (BEIGE 6) - BEIGE
octinoxate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-187
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
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)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-187-241 in 1 BOX03/06/201412/31/2021
1NDC:13537-187-236 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201412/31/2021
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(13537-198, 13537-197, 13537-196, 13537-195, 13537-194, 13537-193, 13537-192, 13537-191, 13537-190, 13537-189, 13537-188, 13537-187)

Revised: 4/2025
Document Id: 32c28f6b-8a8b-460c-e063-6394a90aabb9
Set id: bd3d0467-41aa-4a2a-a371-646fc5880f97
Version: 2
Effective Time: 20250414
 
Ventura Corporation LTD