Ventura Corporation (San Juan, P.R)
ēsika Core Sensations Lipstick
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
Active Ingredients
Octinoxate 6.5%, Oxybenzone 2%
ESIKA Uses
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
Caprylic/capric triglyceride, dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, octyldodecanol, vp/hexadecene copolymer, candelilla cera (euphorbia cerifera (candelilla) wax), castor isostearate beeswax succinate, cera alba (beeswax), ozokerite, polyethylene, copernicia cerifera cera (copernicia cerifera (carnauba) wax), tridecyl stearate, silica, glyceryl isostearate, isostearyl alcohol, myristyl myristate, neopentyl glycol dicaprylate/dicaprate, parfum (fragrance), butyrospermum parkii butter (butyrospermum parkii (shea) butter), glycerin, isopropyl myristate, mentha piperita oil (mentha piperita (peppermint) oil), beta-sitosterol, brassica campestris seed oil (brassica campestris (rapeseed) seed oil), sodium saccharin, phenoxyethanol, disteardimonium hectorite, silica silylate, ethyl menthane carboxamide, menthoxypropanediol, microcristallina cera (microcrystalline wax), tocopheryl acetate, methylparaben, petrolatum, phospholipids, bht, mica, schinus terebinthifolius seed extract, propylparaben, cholesterol, butylparaben, ethylparaben, cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, isobutylparaben, glycosphingolipids, dimethicone, trimethylsiloxysilicate. May Contain: diisopropyl dimer dilinoleate, ricinus communis seed oil (ricinus communis (castor) seed oil), hydrogenated polyisobutene, cetyl alcohol, menthyl lactate, propylene glycol, dipalmitoyl hydroxyproline, CI 15850 (red 7 lake), CI 77491 (iron oxides), CI 77492 (iron oxides), CI 77499 (iron oxides), CI 77019 (mica), CI 45410 (red 27 lake), CI 77891 (titanium dioxide ), CI 19140 (yellow 5 lake), CI 45380 (red 21 lake), CI 75470 (carmine), ppg-26-buteth-26, bertholletia excelsa seed oil, orbignya oleifera seed oil, peg-40 hydrogenated castor oil, silica dimethyl silylate, cetearyl ethylhexanoate, aqua (water), hydrogenated coconut oil, oleyl alcohol, cetyl ricinoleate, talc.
PRINCIPAL DISPLAY PANEL - 4 g Carton - MARRÓN DELICIA
ēsika
Core Sensations
Lipstick
4 g e (.14 oz.)
ESIKA
OCTINOXATE and OXYBENZONE LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-364 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.020 g
|
Product Characteristics
|
|
Color
|
|
BROWN (MARRÓN DELICIA) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-364-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-364-02 |
1 in 1 CARTON |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-06-02 |
|
|
ESIKA
OCTINOXATE and OXYBENZONE LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-365 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.020 g
|
Product Characteristics
|
|
Color
|
|
RED (ROJO AMOROSO) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-365-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-365-02 |
1 in 1 CARTON |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-06-02 |
|
|
ESIKA
OCTINOXATE and OXYBENZONE LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-366 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.020 g
|
Product Characteristics
|
|
Color
|
|
ORANGE (CIRUELA CONFIDENTE) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-366-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-366-02 |
1 in 1 CARTON |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-06-02 |
|
|
ESIKA
OCTINOXATE and OXYBENZONE LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-367 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.020 g
|
Product Characteristics
|
|
Color
|
|
RED (FRESA COQUETA) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-367-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-367-02 |
1 in 1 CARTON |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-06-02 |
|
|
ESIKA
OCTINOXATE and OXYBENZONE LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-368 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.020 g
|
Product Characteristics
|
|
Color
|
|
PINK (MAGENTA ENAMORADA) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-368-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-368-02 |
1 in 1 CARTON |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-06-02 |
|
|
ESIKA
OCTINOXATE and OXYBENZONE LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-369 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.020 g
|
Product Characteristics
|
|
Color
|
|
RED (ROSA TERNURA) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-369-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-369-02 |
1 in 1 CARTON |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-06-02 |
|
|
ESIKA
OCTINOXATE and OXYBENZONE LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-370 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.020 g
|
Product Characteristics
|
|
Color
|
|
PINK (MALVA ROMÁNTICA) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-370-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-370-02 |
1 in 1 CARTON |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-06-02 |
|
|
ESIKA
OCTINOXATE and OXYBENZONE LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-371 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.020 g
|
Product Characteristics
|
|
Color
|
|
RED (VINO SEDUCTOR) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-371-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-371-02 |
1 in 1 CARTON |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-06-02 |
|
|
ESIKA
OCTINOXATE and OXYBENZONE LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-372 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.020 g
|
Product Characteristics
|
|
Color
|
|
BROWN (BRONCE CAUTIVANTE) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-372-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-372-02 |
1 in 1 CARTON |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-06-02 |
|
|
ESIKA
OCTINOXATE and OXYBENZONE LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-373 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.020 g
|
Product Characteristics
|
|
Color
|
|
RED (FUCSIA FESTIVA) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-373-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-373-02 |
1 in 1 CARTON |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-06-02 |
|
|
ESIKA
OCTINOXATE and OXYBENZONE LIPSTICK
Product Information
|
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:13537-374 |
|
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
OCTINOXATE OCTINOXATE |
|
0.065 g
|
|
OXYBENZONE OXYBENZONE |
|
0.020 g
|
Product Characteristics
|
|
Color
|
|
ORANGE (CORAL ENCANTADOR) |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:13537-374-01 |
4 in 1 TUBE |
|
|
|
2 |
NDC:13537-374-02 |
1 in 1 CARTON |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
part |
part352 |
2011-06-02 |
|
|
