ESIKA Hydro-Nutrative Foundation SPF 13

Dosage form: lotion
Ingredients: Octinoxate 0.05mg in 1mL, Oxybenzone 0.02mg in 1mL
Labeler: Ventura Corporation (San Juan, P.R)
NDC Code: 13537-305

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ēsika
Hydro-Nutritive
Foundation
SPF 13

Drug Facts

Active Ingredients

Octinoxate (5%), Oxybenzone (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 to the forehead, nose, chin and both cheeks. Blend with circular motion and spread softly.
  • 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

Aqua (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, rosa centifolia flower water, sodium chloride, mannitol, dimethicone, propylene carbonate, propylene glycol, phenoxyethanol, octyldodecanol, butylene glycol, dimethiconol, methylparaben, propylparaben, cetearyl dimethicone crosspolymer, tocopheryl acetate, microcristallina cera (microcrystalline wax), methicone, polymethylsilsesquioxane, petrolatum, phospholipids, bha, bht, cyclodextrin, butylparaben, ethylparaben, cholesterol, faex extract (yeast extract), isobutylparaben, candelilla cera (euphorbia cerifera (candelilla) wax), cera alba (beeswax), cetearyl alcohol, cetearyl glucoside, copernicia cerifera cera (copernicia cerifera (carnauba) wax), polyglyceryl-2 dipolyhydroxystearate, olea europaea oil unsaponifiables (olea europaea (olive) oil unsaponifiables), glycosphingolipids, disodium succinate. May contain: CI 77891 (titanium dioxide), CI 77492 (iron oxides), CI 77491 (iron oxides), CI 77499 (iron oxides).

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Beige 1

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Beige 2

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Beige 3

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Beige 4

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Beige 5

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Beige 6

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Rosa 1

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Rosa 2

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Rosa 3

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Rosa 4

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Rosa 5

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Rosa 6

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-305
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.05 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone0.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 
cyclomethicone 5 
talc 
polyglyceryl-4 isostearate 
pea 
hexyl laurate 
cyclomethicone 6 
rosa centifolia flower oil 
sodium chloride 
mannitol 
dimethicone 
propylene carbonate 
propylene glycol 
phenoxyethanol 
octyldodecanol 
butylene glycol 
methylparaben 
propylparaben 
microcrystalline wax 
petrolatum 
butylated hydroxyanisole 
butylated hydroxytoluene 
butylparaben 
ethylparaben 
cholesterol 
yeast 
isobutylparaben 
candelilla wax 
yellow wax 
cetostearyl alcohol 
cetearyl glucoside 
carnauba wax 
olive oil 
sodium succinate anhydrous 
titanium dioxide 
ferric oxide yellow 
ferric oxide red 
ferrosoferric oxide 
Product Characteristics
ColorBROWN (Beige 1) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13537-305-021 BOTTLE (BOTTLE) in 1 BOX
1NDC:13537-305-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-306
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.05 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone0.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 
cyclomethicone 5 
talc 
polyglyceryl-4 isostearate 
pea 
hexyl laurate 
cyclomethicone 6 
rosa centifolia flower oil 
sodium chloride 
mannitol 
dimethicone 
propylene carbonate 
propylene glycol 
phenoxyethanol 
octyldodecanol 
butylene glycol 
methylparaben 
propylparaben 
microcrystalline wax 
petrolatum 
butylated hydroxyanisole 
butylated hydroxytoluene 
butylparaben 
ethylparaben 
cholesterol 
yeast 
isobutylparaben 
candelilla wax 
yellow wax 
cetostearyl alcohol 
cetearyl glucoside 
carnauba wax 
olive oil 
sodium succinate anhydrous 
titanium dioxide 
ferric oxide yellow 
ferric oxide red 
ferrosoferric oxide 
Product Characteristics
ColorBROWN (Beige 2) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13537-306-021 BOTTLE (BOTTLE) in 1 BOX
1NDC:13537-306-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-307
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.05 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone0.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 
cyclomethicone 5 
talc 
polyglyceryl-4 isostearate 
pea 
hexyl laurate 
cyclomethicone 6 
rosa centifolia flower oil 
sodium chloride 
mannitol 
dimethicone 
propylene carbonate 
propylene glycol 
phenoxyethanol 
octyldodecanol 
butylene glycol 
methylparaben 
propylparaben 
microcrystalline wax 
petrolatum 
butylated hydroxyanisole 
butylated hydroxytoluene 
butylparaben 
ethylparaben 
cholesterol 
yeast 
isobutylparaben 
candelilla wax 
yellow wax 
cetostearyl alcohol 
cetearyl glucoside 
carnauba wax 
olive oil 
sodium succinate anhydrous 
titanium dioxide 
ferric oxide yellow 
ferric oxide red 
ferrosoferric oxide 
Product Characteristics
ColorBROWN (Beige 3) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13537-307-021 BOTTLE (BOTTLE) in 1 BOX
1NDC:13537-307-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-308
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.05 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone0.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 
cyclomethicone 5 
talc 
polyglyceryl-4 isostearate 
pea 
hexyl laurate 
cyclomethicone 6 
rosa centifolia flower oil 
sodium chloride 
mannitol 
dimethicone 
propylene carbonate 
propylene glycol 
phenoxyethanol 
octyldodecanol 
butylene glycol 
methylparaben 
propylparaben 
microcrystalline wax 
petrolatum 
butylated hydroxyanisole 
butylated hydroxytoluene 
butylparaben 
ethylparaben 
cholesterol 
yeast 
isobutylparaben 
candelilla wax 
yellow wax 
cetostearyl alcohol 
cetearyl glucoside 
carnauba wax 
olive oil 
sodium succinate anhydrous 
titanium dioxide 
ferric oxide yellow 
ferric oxide red 
ferrosoferric oxide 
Product Characteristics
ColorBROWN (Beige 4) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13537-308-021 BOTTLE (BOTTLE) in 1 BOX
1NDC:13537-308-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-309
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.05 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone0.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 
cyclomethicone 5 
talc 
polyglyceryl-4 isostearate 
pea 
hexyl laurate 
cyclomethicone 6 
rosa centifolia flower oil 
sodium chloride 
mannitol 
dimethicone 
propylene carbonate 
propylene glycol 
phenoxyethanol 
octyldodecanol 
butylene glycol 
methylparaben 
propylparaben 
microcrystalline wax 
petrolatum 
butylated hydroxyanisole 
butylated hydroxytoluene 
butylparaben 
ethylparaben 
cholesterol 
yeast 
isobutylparaben 
candelilla wax 
yellow wax 
cetostearyl alcohol 
cetearyl glucoside 
carnauba wax 
olive oil 
sodium succinate anhydrous 
titanium dioxide 
ferric oxide yellow 
ferric oxide red 
ferrosoferric oxide 
Product Characteristics
ColorBROWN (Beige 5) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13537-309-021 BOTTLE (BOTTLE) in 1 BOX
1NDC:13537-309-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-310
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.05 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone0.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 
cyclomethicone 5 
talc 
polyglyceryl-4 isostearate 
pea 
hexyl laurate 
cyclomethicone 6 
rosa centifolia flower oil 
sodium chloride 
mannitol 
dimethicone 
propylene carbonate 
propylene glycol 
phenoxyethanol 
octyldodecanol 
butylene glycol 
methylparaben 
propylparaben 
microcrystalline wax 
petrolatum 
butylated hydroxyanisole 
butylated hydroxytoluene 
butylparaben 
ethylparaben 
cholesterol 
yeast 
isobutylparaben 
candelilla wax 
yellow wax 
cetostearyl alcohol 
cetearyl glucoside 
carnauba wax 
olive oil 
sodium succinate anhydrous 
titanium dioxide 
ferric oxide yellow 
ferric oxide red 
ferrosoferric oxide 
Product Characteristics
ColorBROWN (Beige 6) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13537-310-021 BOTTLE (BOTTLE) in 1 BOX
1NDC:13537-310-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-311
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.05 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone0.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 
cyclomethicone 5 
talc 
polyglyceryl-4 isostearate 
pea 
hexyl laurate 
cyclomethicone 6 
rosa centifolia flower oil 
sodium chloride 
mannitol 
dimethicone 
propylene carbonate 
propylene glycol 
phenoxyethanol 
octyldodecanol 
butylene glycol 
methylparaben 
propylparaben 
microcrystalline wax 
petrolatum 
butylated hydroxyanisole 
butylated hydroxytoluene 
butylparaben 
ethylparaben 
cholesterol 
yeast 
isobutylparaben 
candelilla wax 
yellow wax 
cetostearyl alcohol 
cetearyl glucoside 
carnauba wax 
olive oil 
sodium succinate anhydrous 
titanium dioxide 
ferric oxide yellow 
ferric oxide red 
ferrosoferric oxide 
Product Characteristics
ColorRED (Rosa 1) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13537-311-021 BOTTLE (BOTTLE) in 1 BOX
1NDC:13537-311-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-312
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.05 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone0.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 
cyclomethicone 5 
talc 
polyglyceryl-4 isostearate 
pea 
hexyl laurate 
cyclomethicone 6 
rosa centifolia flower oil 
sodium chloride 
mannitol 
dimethicone 
propylene carbonate 
propylene glycol 
phenoxyethanol 
octyldodecanol 
butylene glycol 
methylparaben 
propylparaben 
microcrystalline wax 
petrolatum 
butylated hydroxyanisole 
butylated hydroxytoluene 
butylparaben 
ethylparaben 
cholesterol 
yeast 
isobutylparaben 
candelilla wax 
yellow wax 
cetostearyl alcohol 
cetearyl glucoside 
carnauba wax 
olive oil 
sodium succinate anhydrous 
titanium dioxide 
ferric oxide yellow 
ferric oxide red 
ferrosoferric oxide 
Product Characteristics
ColorRED (Rosa 2) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13537-312-021 BOTTLE (BOTTLE) in 1 BOX
1NDC:13537-312-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-313
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.05 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone0.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 
cyclomethicone 5 
talc 
polyglyceryl-4 isostearate 
pea 
hexyl laurate 
cyclomethicone 6 
rosa centifolia flower oil 
sodium chloride 
mannitol 
dimethicone 
propylene carbonate 
propylene glycol 
phenoxyethanol 
octyldodecanol 
butylene glycol 
methylparaben 
propylparaben 
microcrystalline wax 
petrolatum 
butylated hydroxyanisole 
butylated hydroxytoluene 
butylparaben 
ethylparaben 
cholesterol 
yeast 
isobutylparaben 
candelilla wax 
yellow wax 
cetostearyl alcohol 
cetearyl glucoside 
carnauba wax 
olive oil 
sodium succinate anhydrous 
titanium dioxide 
ferric oxide yellow 
ferric oxide red 
ferrosoferric oxide 
Product Characteristics
ColorRED (Rosa 3) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13537-313-021 BOTTLE (BOTTLE) in 1 BOX
1NDC:13537-313-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-314
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.05 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone0.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 
cyclomethicone 5 
talc 
polyglyceryl-4 isostearate 
pea 
hexyl laurate 
cyclomethicone 6 
rosa centifolia flower oil 
sodium chloride 
mannitol 
dimethicone 
propylene carbonate 
propylene glycol 
phenoxyethanol 
octyldodecanol 
butylene glycol 
methylparaben 
propylparaben 
microcrystalline wax 
petrolatum 
butylated hydroxyanisole 
butylated hydroxytoluene 
butylparaben 
ethylparaben 
cholesterol 
yeast 
isobutylparaben 
candelilla wax 
yellow wax 
cetostearyl alcohol 
cetearyl glucoside 
carnauba wax 
olive oil 
sodium succinate anhydrous 
titanium dioxide 
ferric oxide yellow 
ferric oxide red 
ferrosoferric oxide 
Product Characteristics
ColorRED (Rosa 4) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13537-314-021 BOTTLE (BOTTLE) in 1 BOX
1NDC:13537-314-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-315
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.05 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone0.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 
cyclomethicone 5 
talc 
polyglyceryl-4 isostearate 
pea 
hexyl laurate 
cyclomethicone 6 
rosa centifolia flower oil 
sodium chloride 
mannitol 
dimethicone 
propylene carbonate 
propylene glycol 
phenoxyethanol 
octyldodecanol 
butylene glycol 
methylparaben 
propylparaben 
microcrystalline wax 
petrolatum 
butylated hydroxyanisole 
butylated hydroxytoluene 
butylparaben 
ethylparaben 
cholesterol 
yeast 
isobutylparaben 
candelilla wax 
yellow wax 
cetostearyl alcohol 
cetearyl glucoside 
carnauba wax 
olive oil 
sodium succinate anhydrous 
titanium dioxide 
ferric oxide yellow 
ferric oxide red 
ferrosoferric oxide 
Product Characteristics
ColorRED (Rosa 5) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13537-315-021 BOTTLE (BOTTLE) in 1 BOX
1NDC:13537-315-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-316
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.05 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone0.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 
cyclomethicone 5 
talc 
polyglyceryl-4 isostearate 
pea 
hexyl laurate 
cyclomethicone 6 
rosa centifolia flower oil 
sodium chloride 
mannitol 
dimethicone 
propylene carbonate 
propylene glycol 
phenoxyethanol 
octyldodecanol 
butylene glycol 
methylparaben 
propylparaben 
microcrystalline wax 
petrolatum 
butylated hydroxyanisole 
butylated hydroxytoluene 
butylparaben 
ethylparaben 
cholesterol 
yeast 
isobutylparaben 
candelilla wax 
yellow wax 
cetostearyl alcohol 
cetearyl glucoside 
carnauba wax 
olive oil 
sodium succinate anhydrous 
titanium dioxide 
ferric oxide yellow 
ferric oxide red 
ferrosoferric oxide 
Product Characteristics
ColorRED (Rosa 6) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13537-316-021 BOTTLE (BOTTLE) in 1 BOX
1NDC:13537-316-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
Labeler - Ventura Corporation (San Juan, P.R) (602751344)
Establishment
NameAddressID/FEIOperations
Bel Star S.A. (Colombia)880160197MANUFACTURE

Revised: 05/2011
 
Ventura Corporation (San Juan, P.R)

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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