Ventura Corporation (San Juan, P.R)
Esika Ultra-Softening Lipstick FPS 15
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
Active Ingredients
Octinoxate 6.5%, Oxybenzone 1.82%
Use
Helps prevent sunburn.
Warnings
For external use only.
Stop use if skin rash occurs.
Keep out of reach of children.
Directions
Apply evenly before sun exposure and as needed. Apply lipstick following the curves of natural lip line.
Inactive Ingredients
Ricinus communis seed oil (ricinus communis (castor) seed oil), ethylhexyl palmitate, caprylic/capric triglyceride, polyethylene, candelilla cera (euphorbia cerifera (candelilla) wax), butyrospermum parkii (butyrospermum parkii (shea butter)), cera alba (beeswax), silica dimethyl silylate, glycerin, octyldodecanol, parfum (fragrance), glyceryl isostearate, isostearyl alcohol, sodium saccharin, propylparaben, cera microcristallina (microcrystalline wax), beta-sitosterol, petrolatum, bht, phospholipids, cholesterol, cetearyl alcohol, cetearyl glucoside, copernicia cerifera cera (copernicia cerifera (carnauba ) wax), polyglyceryl-2 dipolyhydroxystearate, glycosphingolipids, CI 77742 (manganese violet), CI 77491 (iron oxides), CI 77499 (iron oxides), CI 77492 (iron oxides), CI 77891 (titanium dioxide ), CI 45410 (red 27 lake), CI 15850 (red 7 lake), CI 45380 (red 21 lake), CI 19140 (yellow 5 lake), CI 77019 (mica), CI 73360 (red 30 lake), talc, CI 42090 (blue 1 lake), CI 75470 (carmine)
PRINCIPAL DISPLAY PANEL - 4 g Carton - ROJO PROVOCACION
ēsika
Ultra-Softening
Lipstick SPF 15
4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - ROJO VIVAZ
ēsika
Ultra-Softening
Lipstick SPF 15
4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - FUCSIA FANTASIA
ēsika
Ultra-Softening
Lipstick SPF 15
4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - FUCSIA SEDUCTOR
ēsika
Ultra-Softening
Lipstick SPF 15
4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - ROSA INTRIGA
ēsika
Ultra-Softening
Lipstick SPF 15
4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - MORADO OBSESION
ēsika
Ultra-Softening
Lipstick SPF 15
4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - ROSA COQUETA
ēsika
Ultra-Softening
Lipstick SPF 15
4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - MALVA ILUSION
ēsika
Ultra-Softening
Lipstick SPF 15
4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - VINO SENSUAL
ēsika
Ultra-Softening
Lipstick SPF 15
4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - MARRON OTONO
ēsika
Ultra-Softening
Lipstick SPF 15
4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - MARRON TENTACION
ēsika
Ultra-Softening
Lipstick SPF 15
4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - ROSADO MAGICO
ēsika
Ultra-Softening
Lipstick SPF 15
4 g e (.14 oz.)
ESIKA
Octinoxate and Oxybenzone LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-049 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.0182 g
|
Product Characteristics
|
|
Color
|
|
RED (ROJO PROVOCACION) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-049-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-049-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-09-23 |
|
|
ESIKA
Octinoxate and Oxybenzone LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-050 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.0182 g
|
Product Characteristics
|
|
Color
|
|
RED (ROJO VIVAZ) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-050-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-050-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-09-23 |
|
|
ESIKA
Octinoxate and Oxybenzone LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-051 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.0182 g
|
Product Characteristics
|
|
Color
|
|
PURPLE (FUCSIA FANTASIA) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-051-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-051-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-09-23 |
|
|
ESIKA
Octinoxate and Oxybenzone LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-052 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.0182 g
|
Product Characteristics
|
|
Color
|
|
PURPLE (FUCSIA SEDUCTOR) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-052-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-052-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-09-23 |
|
|
ESIKA
Octinoxate and Oxybenzone LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-053 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.0182 g
|
Product Characteristics
|
|
Color
|
|
RED (ROSA INTRIGA) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-053-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-053-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-09-23 |
|
|
ESIKA
Octinoxate and Oxybenzone LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-054 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.0182 g
|
Product Characteristics
|
|
Color
|
|
BROWN (MORADO OBSESION) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-054-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-054-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-09-23 |
|
|
ESIKA
Octinoxate and Oxybenzone LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-055 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.0182 g
|
Product Characteristics
|
|
Color
|
|
RED (ROSA COQUETA) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-055-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-055-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-09-23 |
|
|
ESIKA
Octinoxate and Oxybenzone LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-056 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.0182 g
|
Product Characteristics
|
|
Color
|
|
PINK (MALVA ILUSION) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-056-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-056-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-09-23 |
|
|
ESIKA
Octinoxate and Oxybenzone LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-057 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.0182 g
|
Product Characteristics
|
|
Color
|
|
RED (VINO SENSUAL) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-057-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-057-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-09-23 |
|
|
ESIKA
Octinoxate and Oxybenzone LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-058 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.0182 g
|
Product Characteristics
|
|
Color
|
|
BROWN (MARRON OTONO) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-058-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-058-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-09-23 |
|
|
ESIKA
Octinoxate and Oxybenzone LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-059 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.0182 g
|
Product Characteristics
|
|
Color
|
|
BROWN (MARRON TENTACION) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-059-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-059-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-09-23 |
|
|
ESIKA
Octinoxate and Oxybenzone LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-060 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.0182 g
|
Product Characteristics
|
|
Color
|
|
PINK (ROSADO MAGICO) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-060-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-060-02 |
1 in 1 BOX |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-09-23 |
|
|
