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ESIKA

Ventura Corporation (San Juan, P.R)

ēsika Maximum Color Lipstick SPF 18


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

Octinoxate 7.3%, Oxybenzone 1.65%

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

Diisopropyl dimer dilinoleate, ethylhexyl palmitate, ozokerite, copernicia cerifera cera (copernicia cerifera (carnauba ) wax), polyethylene, butyrospermum parkii butter (butyrospermum parkii (shea) butter), silica, octyldodecanol, aqua (water), phenoxyethanol, microcristallina cera (microcrystalline wax), petrolatum, phospholipids, methylparaben, parfum (fragrance), bht, cholesterol, butylparaben, ethylparaben, candelilla cera (euphorbia cerifera (candelilla) wax), cera alba (beeswax), cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, isobutylparaben, propylparaben, glycosphingolipids, maltodextrin, zea mays starch( zea mays (corn) starch), sodium hyaluronate, CI 15850 (red 7 lake), CI 45410 (red 27 lake), CI 77491 (iron oxides), CI 77492 (iron oxides), CI 77499 (iron oxides), CI 77019 (mica), CI 19140 (yellow 5 lake), CI 77891 (titanium dioxide ), CI 15850 (red 6 lake), isononyl isononanoate, talc, isopropyl myristate, CI 42090 (blue 1 lake), CI 75470 (carmine), isopropyl titanium triisostearate, triethoxycaprylylsilane, stearalkonium hectorite, C9-15 fluoroalcohol phosphate, polyhydroxystearic acid, propylene carbonate.

PRINCIPAL DISPLAY PANEL - 4 g Carton - Rojo Amor

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 4 g Carton - Naranja Vivaz

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 4 g Carton - Rojo Cherry

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 4 g Carton - Fucsia Fancy

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 4 g Carton - Magenta Atrevida

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 4 g Carton - Vino Glamour

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 4 g Carton - Rosa Divina

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 4 g Carton - Coral Shine

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 4 g Carton - Mocca Misterio

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 4 g Carton - Marron Calido

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

ESIKA

ESIKA

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-343
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.073 g
OXYBENZONE OXYBENZONE 0.0165 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
carnauba wax
SHEA BUTTER
SILICON DIOXIDE
OCTYLDODECANOL
water
PHENOXYETHANOL
MICROCRYSTALLINE WAX
petrolatum
METHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
PROPYLPARABEN
maltodextrin
STARCH, CORN
HYALURONATE SODIUM
D&C RED NO. 7
D&C RED NO. 28
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
FD&C YELLOW NO. 5
titanium dioxide
D&C RED NO. 6
ISONONYL ISONONANOATE
talc
ISOPROPYL MYRISTATE
FD&C BLUE NO. 1
COCHINEAL
TRIETHOXYCAPRYLYLSILANE
PROPYLENE CARBONATE

Product Characteristics

Color
RED (Rojo Amor)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-343-01 4 in 1 TUBE
2 NDC:13537-343-02 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 LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-344
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.073 g
OXYBENZONE OXYBENZONE 0.0165 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
carnauba wax
SHEA BUTTER
SILICON DIOXIDE
OCTYLDODECANOL
water
PHENOXYETHANOL
MICROCRYSTALLINE WAX
petrolatum
METHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
PROPYLPARABEN
maltodextrin
STARCH, CORN
HYALURONATE SODIUM
D&C RED NO. 7
D&C RED NO. 28
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
FD&C YELLOW NO. 5
titanium dioxide
D&C RED NO. 6
ISONONYL ISONONANOATE
talc
ISOPROPYL MYRISTATE
FD&C BLUE NO. 1
COCHINEAL
TRIETHOXYCAPRYLYLSILANE
PROPYLENE CARBONATE

Product Characteristics

Color
ORANGE (Naranja Vivaz)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-344-01 4 in 1 TUBE
2 NDC:13537-344-02 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 LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-345
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.073 g
OXYBENZONE OXYBENZONE 0.0165 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
carnauba wax
SHEA BUTTER
SILICON DIOXIDE
OCTYLDODECANOL
water
PHENOXYETHANOL
MICROCRYSTALLINE WAX
petrolatum
METHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
PROPYLPARABEN
maltodextrin
STARCH, CORN
HYALURONATE SODIUM
D&C RED NO. 7
D&C RED NO. 28
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
FD&C YELLOW NO. 5
titanium dioxide
D&C RED NO. 6
ISONONYL ISONONANOATE
talc
ISOPROPYL MYRISTATE
FD&C BLUE NO. 1
COCHINEAL
TRIETHOXYCAPRYLYLSILANE
PROPYLENE CARBONATE

Product Characteristics

Color
RED (Rojo Cherry)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-345-01 4 in 1 TUBE
2 NDC:13537-345-02 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 LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-346
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.073 g
OXYBENZONE OXYBENZONE 0.0165 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
carnauba wax
SHEA BUTTER
SILICON DIOXIDE
OCTYLDODECANOL
water
PHENOXYETHANOL
MICROCRYSTALLINE WAX
petrolatum
METHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
PROPYLPARABEN
maltodextrin
STARCH, CORN
HYALURONATE SODIUM
D&C RED NO. 7
D&C RED NO. 28
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
FD&C YELLOW NO. 5
titanium dioxide
D&C RED NO. 6
ISONONYL ISONONANOATE
talc
ISOPROPYL MYRISTATE
FD&C BLUE NO. 1
COCHINEAL
TRIETHOXYCAPRYLYLSILANE
PROPYLENE CARBONATE

Product Characteristics

Color
PINK (Fucsia Fancy)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-346-01 4 in 1 TUBE
2 NDC:13537-346-02 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 LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-347
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.073 g
OXYBENZONE OXYBENZONE 0.0165 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
carnauba wax
SHEA BUTTER
SILICON DIOXIDE
OCTYLDODECANOL
water
PHENOXYETHANOL
MICROCRYSTALLINE WAX
petrolatum
METHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
PROPYLPARABEN
maltodextrin
STARCH, CORN
HYALURONATE SODIUM
D&C RED NO. 7
D&C RED NO. 28
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
FD&C YELLOW NO. 5
titanium dioxide
D&C RED NO. 6
ISONONYL ISONONANOATE
talc
ISOPROPYL MYRISTATE
FD&C BLUE NO. 1
COCHINEAL
TRIETHOXYCAPRYLYLSILANE
PROPYLENE CARBONATE

Product Characteristics

Color
PURPLE (Magenta Atrevida)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-347-01 4 in 1 TUBE
2 NDC:13537-347-02 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 LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-348
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.073 g
OXYBENZONE OXYBENZONE 0.0165 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
carnauba wax
SHEA BUTTER
SILICON DIOXIDE
OCTYLDODECANOL
water
PHENOXYETHANOL
MICROCRYSTALLINE WAX
petrolatum
METHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
PROPYLPARABEN
maltodextrin
STARCH, CORN
HYALURONATE SODIUM
D&C RED NO. 7
D&C RED NO. 28
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
FD&C YELLOW NO. 5
titanium dioxide
D&C RED NO. 6
ISONONYL ISONONANOATE
talc
ISOPROPYL MYRISTATE
FD&C BLUE NO. 1
COCHINEAL
TRIETHOXYCAPRYLYLSILANE
PROPYLENE CARBONATE

Product Characteristics

Color
RED (Vino Glamour)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-348-01 4 in 1 TUBE
2 NDC:13537-348-02 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 LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-349
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.073 g
OXYBENZONE OXYBENZONE 0.0165 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
carnauba wax
SHEA BUTTER
SILICON DIOXIDE
OCTYLDODECANOL
water
PHENOXYETHANOL
MICROCRYSTALLINE WAX
petrolatum
METHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
PROPYLPARABEN
maltodextrin
STARCH, CORN
HYALURONATE SODIUM
D&C RED NO. 7
D&C RED NO. 28
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
FD&C YELLOW NO. 5
titanium dioxide
D&C RED NO. 6
ISONONYL ISONONANOATE
talc
ISOPROPYL MYRISTATE
FD&C BLUE NO. 1
COCHINEAL
TRIETHOXYCAPRYLYLSILANE
PROPYLENE CARBONATE

Product Characteristics

Color
RED (Rosa Divina)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-349-01 4 in 1 TUBE
2 NDC:13537-349-02 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 LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-350
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.073 g
OXYBENZONE OXYBENZONE 0.0165 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
carnauba wax
SHEA BUTTER
SILICON DIOXIDE
OCTYLDODECANOL
water
PHENOXYETHANOL
MICROCRYSTALLINE WAX
petrolatum
METHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
PROPYLPARABEN
maltodextrin
STARCH, CORN
HYALURONATE SODIUM
D&C RED NO. 7
D&C RED NO. 28
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
FD&C YELLOW NO. 5
titanium dioxide
D&C RED NO. 6
ISONONYL ISONONANOATE
talc
ISOPROPYL MYRISTATE
FD&C BLUE NO. 1
COCHINEAL
TRIETHOXYCAPRYLYLSILANE
PROPYLENE CARBONATE

Product Characteristics

Color
RED (Coral Shine)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-350-01 4 in 1 TUBE
2 NDC:13537-350-02 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 LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-351
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.073 g
OXYBENZONE OXYBENZONE 0.0165 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
carnauba wax
SHEA BUTTER
SILICON DIOXIDE
OCTYLDODECANOL
water
PHENOXYETHANOL
MICROCRYSTALLINE WAX
petrolatum
METHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
PROPYLPARABEN
maltodextrin
STARCH, CORN
HYALURONATE SODIUM
D&C RED NO. 7
D&C RED NO. 28
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
FD&C YELLOW NO. 5
titanium dioxide
D&C RED NO. 6
ISONONYL ISONONANOATE
talc
ISOPROPYL MYRISTATE
FD&C BLUE NO. 1
COCHINEAL
TRIETHOXYCAPRYLYLSILANE
PROPYLENE CARBONATE

Product Characteristics

Color
BROWN (Mocca Misterio)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-351-01 4 in 1 TUBE
2 NDC:13537-351-02 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 LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-352
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.073 g
OXYBENZONE OXYBENZONE 0.0165 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
carnauba wax
SHEA BUTTER
SILICON DIOXIDE
OCTYLDODECANOL
water
PHENOXYETHANOL
MICROCRYSTALLINE WAX
petrolatum
METHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
PROPYLPARABEN
maltodextrin
STARCH, CORN
HYALURONATE SODIUM
D&C RED NO. 7
D&C RED NO. 28
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
FD&C YELLOW NO. 5
titanium dioxide
D&C RED NO. 6
ISONONYL ISONONANOATE
talc
ISOPROPYL MYRISTATE
FD&C BLUE NO. 1
COCHINEAL
TRIETHOXYCAPRYLYLSILANE
PROPYLENE CARBONATE

Product Characteristics

Color
BROWN (Marron Calido)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-352-01 4 in 1 TUBE
2 NDC:13537-352-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-05-17


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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