Ventura Corporation (San Juan, P.R)
ēsika Hydrated Face Makeup Foundation SPF 15
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
Drug Facts
Active Ingredients
Octinoxate (6%)
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 smoothly 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), coco-caprylate/caprate, ethylhexyl palmitate, glycerin, octyldodecanol, polymethyl methacrylate, cyclopentasiloxane, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, sodium chloride, talc, dimethicone, hexyl laurate, dimethicone/vinyl dimethicone crosspolymer, cyclomethicone, disteardimonium hectorite, cyclohexasiloxane, glycine soja protein (glycine soja (soybean) protein), microcrystalline wax, diazolidinyl urea, cetearyl dimethicone crosspolymer, methylparaben, propylparaben, tocopheryl acetate, petrolatum, dimethiconol, phospholipids, cholesterol, silica, bha, bht, candelilla cera (euphorbia cerifera (candelilla) wax), beeswax, cetearyl alcohol, cetearyl glucoside, copernicia cerifera cera (copernicia cerifera (carnauba) wax), polyglyceryl-2 dipolyhydroxystearate, glycosphingolipids, triethoxycaprylylsilane, ci 77891 (titanium dioxide ), ci 77492 (iron oxides), ci 77491( iron oxides), ci 77499 (iron oxides).
PRINCIPAL DISPLAY PANEL - 30 g Carton
ēsika
Hydrated Face Makeup Foundation SPF 15
30 g e (1 oz.)
Product Information
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|
Product Type
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Human otc drug label |
Item Code (Source)
|
NDC:13537-317 |
|
Route of Administration
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TOPICAL |
DEA Schedule
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|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.06 g
|
Product Characteristics
|
|
Color
|
|
BROWN (Beige 1) |
|
|
Packaging
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#
|
Item Code
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Package Description
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Marketing Start Date
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Marketing End Date
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1 |
NDC:13537-317-01 |
30 in 1 JAR |
|
|
|
2 |
NDC:13537-317-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-318 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.06 g
|
Product Characteristics
|
|
Color
|
|
BROWN (Beige 2) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
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Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-318-01 |
30 in 1 JAR |
|
|
|
2 |
NDC:13537-318-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-319 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.06 g
|
Product Characteristics
|
|
Color
|
|
BROWN (Beige 3) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-319-01 |
30 in 1 JAR |
|
|
|
2 |
NDC:13537-319-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-320 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.06 g
|
Product Characteristics
|
|
Color
|
|
BROWN (Beige 4) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-320-01 |
30 in 1 JAR |
|
|
|
2 |
NDC:13537-320-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-321 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.06 g
|
Product Characteristics
|
|
Color
|
|
BROWN (Beige 5) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-321-01 |
30 in 1 JAR |
|
|
|
2 |
NDC:13537-321-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-322 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.06 g
|
Product Characteristics
|
|
Color
|
|
BROWN (Beige 6) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-322-01 |
30 in 1 JAR |
|
|
|
2 |
NDC:13537-322-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-323 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.06 g
|
Product Characteristics
|
|
Color
|
|
RED (Rosa 1) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-323-01 |
30 in 1 JAR |
|
|
|
2 |
NDC:13537-323-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-324 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.06 g
|
Product Characteristics
|
|
Color
|
|
RED (Rosa 2) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-324-01 |
30 in 1 JAR |
|
|
|
2 |
NDC:13537-324-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-325 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.06 g
|
Product Characteristics
|
|
Color
|
|
RED (Rosa 3) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-325-01 |
30 in 1 JAR |
|
|
|
2 |
NDC:13537-325-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-326 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.06 g
|
Product Characteristics
|
|
Color
|
|
RED (Rosa 4) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-326-01 |
30 in 1 JAR |
|
|
|
2 |
NDC:13537-326-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-327 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.06 g
|
Product Characteristics
|
|
Color
|
|
RED (Rosa 5) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-327-01 |
30 in 1 JAR |
|
|
|
2 |
NDC:13537-327-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-328 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.06 g
|
Product Characteristics
|
|
Color
|
|
RED (Rosa 6) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-328-01 |
30 in 1 JAR |
|
|
|
2 |
NDC:13537-328-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-05-17 |
|
|
