Ventura Corporation (San Juan, P.R)
ēsika Hydro-Nutritive Foundation SPF 13
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
Drug Facts
Active Ingredients
Octinoxate (5%), Oxybenzone (2%)
Purpose
Sunscreen
ESIKA Uses
- Helps prevent sunburn.
- Higher SPF gives more sunburn protection.
- Provides moderate protection against sunburn.
Warnings
- 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.
ESIKA 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
Octinoxate and Oxybenzone LOTION
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-305 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.05 mg
|
|
OXYBENZONE OXYBENZONE |
|
0.02 mg
|
Product Characteristics
|
|
Color
|
|
BROWN (Beige 1) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-305-01 |
30 in 1 BOTTLE |
|
|
|
2 |
NDC:13537-305-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
ESIKA
Octinoxate and Oxybenzone LOTION
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-306 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.05 mg
|
|
OXYBENZONE OXYBENZONE |
|
0.02 mg
|
Product Characteristics
|
|
Color
|
|
BROWN (Beige 2) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-306-01 |
30 in 1 BOTTLE |
|
|
|
2 |
NDC:13537-306-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
ESIKA
Octinoxate and Oxybenzone LOTION
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-307 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.05 mg
|
|
OXYBENZONE OXYBENZONE |
|
0.02 mg
|
Product Characteristics
|
|
Color
|
|
BROWN (Beige 3) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-307-01 |
30 in 1 BOTTLE |
|
|
|
2 |
NDC:13537-307-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
ESIKA
Octinoxate and Oxybenzone LOTION
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-308 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.05 mg
|
|
OXYBENZONE OXYBENZONE |
|
0.02 mg
|
Product Characteristics
|
|
Color
|
|
BROWN (Beige 4) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-308-01 |
30 in 1 BOTTLE |
|
|
|
2 |
NDC:13537-308-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
ESIKA
Octinoxate and Oxybenzone LOTION
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-309 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.05 mg
|
|
OXYBENZONE OXYBENZONE |
|
0.02 mg
|
Product Characteristics
|
|
Color
|
|
BROWN (Beige 5) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-309-01 |
30 in 1 BOTTLE |
|
|
|
2 |
NDC:13537-309-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
ESIKA
Octinoxate and Oxybenzone LOTION
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-310 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.05 mg
|
|
OXYBENZONE OXYBENZONE |
|
0.02 mg
|
Product Characteristics
|
|
Color
|
|
BROWN (Beige 6) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-310-01 |
30 in 1 BOTTLE |
|
|
|
2 |
NDC:13537-310-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
ESIKA
Octinoxate and Oxybenzone LOTION
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-311 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.05 mg
|
|
OXYBENZONE OXYBENZONE |
|
0.02 mg
|
Product Characteristics
|
|
Color
|
|
RED (Rosa 1) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-311-01 |
30 in 1 BOTTLE |
|
|
|
2 |
NDC:13537-311-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
ESIKA
Octinoxate and Oxybenzone LOTION
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-312 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.05 mg
|
|
OXYBENZONE OXYBENZONE |
|
0.02 mg
|
Product Characteristics
|
|
Color
|
|
RED (Rosa 2) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-312-01 |
30 in 1 BOTTLE |
|
|
|
2 |
NDC:13537-312-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
ESIKA
Octinoxate and Oxybenzone LOTION
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-313 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.05 mg
|
|
OXYBENZONE OXYBENZONE |
|
0.02 mg
|
Product Characteristics
|
|
Color
|
|
RED (Rosa 3) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-313-01 |
30 in 1 BOTTLE |
|
|
|
2 |
NDC:13537-313-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
ESIKA
Octinoxate and Oxybenzone LOTION
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-314 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.05 mg
|
|
OXYBENZONE OXYBENZONE |
|
0.02 mg
|
Product Characteristics
|
|
Color
|
|
RED (Rosa 4) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-314-01 |
30 in 1 BOTTLE |
|
|
|
2 |
NDC:13537-314-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
ESIKA
Octinoxate and Oxybenzone LOTION
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-315 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.05 mg
|
|
OXYBENZONE OXYBENZONE |
|
0.02 mg
|
Product Characteristics
|
|
Color
|
|
RED (Rosa 5) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-315-01 |
30 in 1 BOTTLE |
|
|
|
2 |
NDC:13537-315-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
ESIKA
Octinoxate and Oxybenzone LOTION
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-316 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.05 mg
|
|
OXYBENZONE OXYBENZONE |
|
0.02 mg
|
Product Characteristics
|
|
Color
|
|
RED (Rosa 6) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-316-01 |
30 in 1 BOTTLE |
|
|
|
2 |
NDC:13537-316-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
