ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 1) - BROWN- octinoxate and oxybenzone emulsion 
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 2) - BROWN- octinoxate and oxybenzone emulsion 
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 3) - BROWN- octinoxate and oxybenzone emulsion 
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 4) - BROWN- octinoxate and oxybenzone emulsion 
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 5) - BROWN- octinoxate and oxybenzone emulsion 
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 6) - BROWN- octinoxate and oxybenzone emulsion 
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 1) - PINK- octinoxate and oxybenzone emulsion 
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 2) - PINK- octinoxate and oxybenzone emulsion 
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 3) - PINK- octinoxate and oxybenzone emulsion 
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 4) - PINK- octinoxate and oxybenzone emulsion 
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 5) - PINK- octinoxate and oxybenzone emulsion 
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 6) - PINK- octinoxate and oxybenzone emulsion 
Ventura Corporation LTD

----------

ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15

Drug Facts

Active IngredientsPurpose
OCTINOXATE: 5.00%Sunscreen
OXYBENZONE: 2.00%Sunscreen

Uses

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

  • For external use only.

  • Do not useon damaged 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.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months of age: Ask a doctor
  • Reapply at least every 2 hours.
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses.

Other information

  • Protect this product in this container form excesive heat and direct sun. Keep away from heat sources and direct sunlight. Store well and under 50°C (112°F).

Inactive ingredients

WATER, CYCLOMETHICONE, CYCLOPENTASILOXANE, TALC, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, PISUM SATIVUM (PEA) EXTRACT, PEG-12 DIMETHICONE CROSSPOLYMER, HEXYL LAURATE, ISOSTEARYL NEOPENTANOATE, DISTEARDIMONIUM HECTORITE, CYCLOHEXASILOXANE, HYDROXYACETOPHENONE, ROSA CENTIFOLIA FLOWER WATER, SODIUM CHLORIDE, PHENOXYETHANOL, MANNITOL, DIMETHICONE, PROPYLENE CARBONATE, PROPYLENE GLYCOL, OCTYLDODECANOL, BUTYLENE GLYCOL, DIMETHICONOL, CAPRYLYL GLYCOL, CETEARYL DIMETHICONE CROSSPOLYMER, TOCOPHERYL ACETATE, CHLORPHENESIN, MICROCRYSTALLINE WAX, POLYMETHYLSILSESQUIOXANE, PETROLATUM, PHOSPHOLIPIDS, CYCLODEXTRIN, CHOLESTEROL, YEAST EXTRACT, EUPHORBIA CERIFERA (CANDELILLA) WAX, BEESWAX, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, COPERNICIA CERIFERA (CARNAUBA ) WAX, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, GLYCOSPHINGOLIPIDS, DISODIUM SUCCINATE.

MAY CONTAIN:

TITANIUM DIOXIDE, METHICONE, IRON OXIDES.

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

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 1) - Brown

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 mle (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 1) - Brown

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 2) - Brown

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 mle (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 2) - Brown

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 3) - Brown

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 mle (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 3) - Brown

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 4) - Brown

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 mle (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 4) - Brown

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 5) - Brown

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 mle (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 5) - Brown

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 6) - Brown

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 mle (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 6) - Brown

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 1) - Pink

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 mle (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 1) - Pink

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 2) - Pink

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 mle (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 2) - Pink

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 3) - Pink

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 mle (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 3) - Pink

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 4) - Pink

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 mle (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 4) - Pink

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 5) - Pink

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 mle (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 5) - Pink

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 6) - Pink

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 mle (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 6) - Pink
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (BEIGE 1) - BROWN
octinoxate and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-625
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TALC (UNII: 7SEV7J4R1U)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PEA (UNII: W4X7H8GYFM)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MANNITOL (UNII: 3OWL53L36A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PETROLATUM (UNII: 4T6H12BN9U)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-625-021 in 1 BOX03/06/201512/31/2021
1NDC:13537-625-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201512/31/2021
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (BEIGE 2) - BROWN
octinoxate and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-626
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TALC (UNII: 7SEV7J4R1U)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PEA (UNII: W4X7H8GYFM)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MANNITOL (UNII: 3OWL53L36A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PETROLATUM (UNII: 4T6H12BN9U)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-626-041 in 1 BOX03/06/201512/31/2021
1NDC:13537-626-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201512/31/2021
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (BEIGE 3) - BROWN
octinoxate and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-627
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TALC (UNII: 7SEV7J4R1U)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PEA (UNII: W4X7H8GYFM)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MANNITOL (UNII: 3OWL53L36A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PETROLATUM (UNII: 4T6H12BN9U)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-627-061 in 1 BOX03/06/201512/31/2021
1NDC:13537-627-0530 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201512/31/2021
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (BEIGE 4) - BROWN
octinoxate and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-628
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TALC (UNII: 7SEV7J4R1U)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PEA (UNII: W4X7H8GYFM)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MANNITOL (UNII: 3OWL53L36A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PETROLATUM (UNII: 4T6H12BN9U)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-628-081 in 1 BOX03/06/201512/31/2021
1NDC:13537-628-0730 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201512/31/2021
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (BEIGE 5) - BROWN
octinoxate and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-629
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TALC (UNII: 7SEV7J4R1U)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PEA (UNII: W4X7H8GYFM)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MANNITOL (UNII: 3OWL53L36A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PETROLATUM (UNII: 4T6H12BN9U)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-629-101 in 1 BOX03/06/201512/31/2021
1NDC:13537-629-0930 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201512/31/2021
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (BEIGE 6) - BROWN
octinoxate and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-630
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TALC (UNII: 7SEV7J4R1U)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PEA (UNII: W4X7H8GYFM)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MANNITOL (UNII: 3OWL53L36A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PETROLATUM (UNII: 4T6H12BN9U)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-630-121 in 1 BOX03/06/201512/31/2021
1NDC:13537-630-1130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201512/31/2021
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (ROSA 1) - PINK
octinoxate and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-631
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TALC (UNII: 7SEV7J4R1U)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PEA (UNII: W4X7H8GYFM)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MANNITOL (UNII: 3OWL53L36A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PETROLATUM (UNII: 4T6H12BN9U)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-631-141 in 1 BOX03/06/201512/31/2021
1NDC:13537-631-1330 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201512/31/2021
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (ROSA 2) - PINK
octinoxate and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-632
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TALC (UNII: 7SEV7J4R1U)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PEA (UNII: W4X7H8GYFM)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MANNITOL (UNII: 3OWL53L36A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PETROLATUM (UNII: 4T6H12BN9U)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-632-161 in 1 BOX03/06/201512/31/2021
1NDC:13537-632-1530 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201512/31/2021
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (ROSA 3) - PINK
octinoxate and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-633
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TALC (UNII: 7SEV7J4R1U)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PEA (UNII: W4X7H8GYFM)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MANNITOL (UNII: 3OWL53L36A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PETROLATUM (UNII: 4T6H12BN9U)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-633-181 in 1 BOX03/06/201512/31/2021
1NDC:13537-633-1730 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201512/31/2021
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (ROSA 4) - PINK
octinoxate and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-634
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TALC (UNII: 7SEV7J4R1U)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PEA (UNII: W4X7H8GYFM)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MANNITOL (UNII: 3OWL53L36A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PETROLATUM (UNII: 4T6H12BN9U)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-634-201 in 1 BOX03/06/201512/31/2021
1NDC:13537-634-1930 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201512/31/2021
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (ROSA 5) - PINK
octinoxate and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-635
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TALC (UNII: 7SEV7J4R1U)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PEA (UNII: W4X7H8GYFM)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MANNITOL (UNII: 3OWL53L36A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PETROLATUM (UNII: 4T6H12BN9U)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-635-221 in 1 BOX03/06/201512/31/2021
1NDC:13537-635-2130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201512/31/2021
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (ROSA 6) - PINK
octinoxate and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-636
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TALC (UNII: 7SEV7J4R1U)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PEA (UNII: W4X7H8GYFM)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MANNITOL (UNII: 3OWL53L36A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PETROLATUM (UNII: 4T6H12BN9U)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-636-241 in 1 BOX03/06/201512/31/2021
1NDC:13537-636-2330 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201512/31/2021
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(13537-625, 13537-626, 13537-627, 13537-628, 13537-629, 13537-630, 13537-631, 13537-632, 13537-633, 13537-634, 13537-635, 13537-636)

Revised: 3/2025
Document Id: 3013a2a2-6c13-31a8-e063-6394a90a4ecd
Set id: a2a25c0b-e094-4e33-9d50-0079e8061423
Version: 4
Effective Time: 20250311
 
Ventura Corporation LTD