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ESIKA

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

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

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
castor oil
TRIDECYL TRIMELLITATE
OCTYLDODECANOL
CANDELILLA WAX
carnauba wax
TRIDECYL STEARATE
CETYL ALCOHOL
Menthyl Lactate
SILICON DIOXIDE
GLYCERYL ISOSTEARATE
ISOSTEARYL ALCOHOL
MYRISTYL MYRISTATE
propylene glycol
Neopentyl Glycol Dicaprate
SHEA BUTTER
DIPALMITOYL HYDROXYPROLINE
GLYCERIN
ISOPROPYL MYRISTATE
PEPPERMINT OIL
BRASSICA RAPA VAR. RAPA OIL
.BETA.-SITOSTEROL
saccharin sodium
PHENOXYETHANOL
ETHYL MENTHANE CARBOXAMIDE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
MICA
BRAZILIAN PEPPER
PROPYLPARABEN
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
DIMETHICONE
D&C RED NO. 7
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
D&C RED NO. 27
titanium dioxide
FD&C YELLOW NO. 5
D&c Red No. 21
BRAZIL NUT OIL
BABASSU OIL
POLYETHYLENE GLYCOL 2000
cetearyl ethylhexanoate
water
COCONUT OIL
OLEYL ALCOHOL
talc

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

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
castor oil
TRIDECYL TRIMELLITATE
OCTYLDODECANOL
CANDELILLA WAX
carnauba wax
TRIDECYL STEARATE
CETYL ALCOHOL
Menthyl Lactate
SILICON DIOXIDE
GLYCERYL ISOSTEARATE
ISOSTEARYL ALCOHOL
MYRISTYL MYRISTATE
propylene glycol
Neopentyl Glycol Dicaprate
SHEA BUTTER
DIPALMITOYL HYDROXYPROLINE
GLYCERIN
ISOPROPYL MYRISTATE
PEPPERMINT OIL
BRASSICA RAPA VAR. RAPA OIL
.BETA.-SITOSTEROL
saccharin sodium
PHENOXYETHANOL
ETHYL MENTHANE CARBOXAMIDE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
MICA
BRAZILIAN PEPPER
PROPYLPARABEN
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
DIMETHICONE
D&C RED NO. 7
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
D&C RED NO. 27
titanium dioxide
FD&C YELLOW NO. 5
D&c Red No. 21
BRAZIL NUT OIL
BABASSU OIL
POLYETHYLENE GLYCOL 2000
cetearyl ethylhexanoate
water
COCONUT OIL
OLEYL ALCOHOL
talc

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

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
castor oil
TRIDECYL TRIMELLITATE
OCTYLDODECANOL
CANDELILLA WAX
carnauba wax
TRIDECYL STEARATE
CETYL ALCOHOL
Menthyl Lactate
SILICON DIOXIDE
GLYCERYL ISOSTEARATE
ISOSTEARYL ALCOHOL
MYRISTYL MYRISTATE
propylene glycol
Neopentyl Glycol Dicaprate
SHEA BUTTER
DIPALMITOYL HYDROXYPROLINE
GLYCERIN
ISOPROPYL MYRISTATE
PEPPERMINT OIL
BRASSICA RAPA VAR. RAPA OIL
.BETA.-SITOSTEROL
saccharin sodium
PHENOXYETHANOL
ETHYL MENTHANE CARBOXAMIDE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
MICA
BRAZILIAN PEPPER
PROPYLPARABEN
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
DIMETHICONE
D&C RED NO. 7
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
D&C RED NO. 27
titanium dioxide
FD&C YELLOW NO. 5
D&c Red No. 21
BRAZIL NUT OIL
BABASSU OIL
POLYETHYLENE GLYCOL 2000
cetearyl ethylhexanoate
water
COCONUT OIL
OLEYL ALCOHOL
talc

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

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
castor oil
TRIDECYL TRIMELLITATE
OCTYLDODECANOL
CANDELILLA WAX
carnauba wax
TRIDECYL STEARATE
CETYL ALCOHOL
Menthyl Lactate
SILICON DIOXIDE
GLYCERYL ISOSTEARATE
ISOSTEARYL ALCOHOL
MYRISTYL MYRISTATE
propylene glycol
Neopentyl Glycol Dicaprate
SHEA BUTTER
DIPALMITOYL HYDROXYPROLINE
GLYCERIN
ISOPROPYL MYRISTATE
PEPPERMINT OIL
BRASSICA RAPA VAR. RAPA OIL
.BETA.-SITOSTEROL
saccharin sodium
PHENOXYETHANOL
ETHYL MENTHANE CARBOXAMIDE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
MICA
BRAZILIAN PEPPER
PROPYLPARABEN
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
DIMETHICONE
D&C RED NO. 7
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
D&C RED NO. 27
titanium dioxide
FD&C YELLOW NO. 5
D&c Red No. 21
BRAZIL NUT OIL
BABASSU OIL
POLYETHYLENE GLYCOL 2000
cetearyl ethylhexanoate
water
COCONUT OIL
OLEYL ALCOHOL
talc

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

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
castor oil
TRIDECYL TRIMELLITATE
OCTYLDODECANOL
CANDELILLA WAX
carnauba wax
TRIDECYL STEARATE
CETYL ALCOHOL
Menthyl Lactate
SILICON DIOXIDE
GLYCERYL ISOSTEARATE
ISOSTEARYL ALCOHOL
MYRISTYL MYRISTATE
propylene glycol
Neopentyl Glycol Dicaprate
SHEA BUTTER
DIPALMITOYL HYDROXYPROLINE
GLYCERIN
ISOPROPYL MYRISTATE
PEPPERMINT OIL
BRASSICA RAPA VAR. RAPA OIL
.BETA.-SITOSTEROL
saccharin sodium
PHENOXYETHANOL
ETHYL MENTHANE CARBOXAMIDE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
MICA
BRAZILIAN PEPPER
PROPYLPARABEN
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
DIMETHICONE
D&C RED NO. 7
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
D&C RED NO. 27
titanium dioxide
FD&C YELLOW NO. 5
D&c Red No. 21
BRAZIL NUT OIL
BABASSU OIL
POLYETHYLENE GLYCOL 2000
cetearyl ethylhexanoate
water
COCONUT OIL
OLEYL ALCOHOL
talc

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

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
castor oil
TRIDECYL TRIMELLITATE
OCTYLDODECANOL
CANDELILLA WAX
carnauba wax
TRIDECYL STEARATE
CETYL ALCOHOL
Menthyl Lactate
SILICON DIOXIDE
GLYCERYL ISOSTEARATE
ISOSTEARYL ALCOHOL
MYRISTYL MYRISTATE
propylene glycol
Neopentyl Glycol Dicaprate
SHEA BUTTER
DIPALMITOYL HYDROXYPROLINE
GLYCERIN
ISOPROPYL MYRISTATE
PEPPERMINT OIL
BRASSICA RAPA VAR. RAPA OIL
.BETA.-SITOSTEROL
saccharin sodium
PHENOXYETHANOL
ETHYL MENTHANE CARBOXAMIDE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
MICA
BRAZILIAN PEPPER
PROPYLPARABEN
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
DIMETHICONE
D&C RED NO. 7
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
D&C RED NO. 27
titanium dioxide
FD&C YELLOW NO. 5
D&c Red No. 21
BRAZIL NUT OIL
BABASSU OIL
POLYETHYLENE GLYCOL 2000
cetearyl ethylhexanoate
water
COCONUT OIL
OLEYL ALCOHOL
talc

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

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
castor oil
TRIDECYL TRIMELLITATE
OCTYLDODECANOL
CANDELILLA WAX
carnauba wax
TRIDECYL STEARATE
CETYL ALCOHOL
Menthyl Lactate
SILICON DIOXIDE
GLYCERYL ISOSTEARATE
ISOSTEARYL ALCOHOL
MYRISTYL MYRISTATE
propylene glycol
Neopentyl Glycol Dicaprate
SHEA BUTTER
DIPALMITOYL HYDROXYPROLINE
GLYCERIN
ISOPROPYL MYRISTATE
PEPPERMINT OIL
BRASSICA RAPA VAR. RAPA OIL
.BETA.-SITOSTEROL
saccharin sodium
PHENOXYETHANOL
ETHYL MENTHANE CARBOXAMIDE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
MICA
BRAZILIAN PEPPER
PROPYLPARABEN
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
DIMETHICONE
D&C RED NO. 7
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
D&C RED NO. 27
titanium dioxide
FD&C YELLOW NO. 5
D&c Red No. 21
BRAZIL NUT OIL
BABASSU OIL
POLYETHYLENE GLYCOL 2000
cetearyl ethylhexanoate
water
COCONUT OIL
OLEYL ALCOHOL
talc

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

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
castor oil
TRIDECYL TRIMELLITATE
OCTYLDODECANOL
CANDELILLA WAX
carnauba wax
TRIDECYL STEARATE
CETYL ALCOHOL
Menthyl Lactate
SILICON DIOXIDE
GLYCERYL ISOSTEARATE
ISOSTEARYL ALCOHOL
MYRISTYL MYRISTATE
propylene glycol
Neopentyl Glycol Dicaprate
SHEA BUTTER
DIPALMITOYL HYDROXYPROLINE
GLYCERIN
ISOPROPYL MYRISTATE
PEPPERMINT OIL
BRASSICA RAPA VAR. RAPA OIL
.BETA.-SITOSTEROL
saccharin sodium
PHENOXYETHANOL
ETHYL MENTHANE CARBOXAMIDE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
MICA
BRAZILIAN PEPPER
PROPYLPARABEN
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
DIMETHICONE
D&C RED NO. 7
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
D&C RED NO. 27
titanium dioxide
FD&C YELLOW NO. 5
D&c Red No. 21
BRAZIL NUT OIL
BABASSU OIL
POLYETHYLENE GLYCOL 2000
cetearyl ethylhexanoate
water
COCONUT OIL
OLEYL ALCOHOL
talc

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

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
castor oil
TRIDECYL TRIMELLITATE
OCTYLDODECANOL
CANDELILLA WAX
carnauba wax
TRIDECYL STEARATE
CETYL ALCOHOL
Menthyl Lactate
SILICON DIOXIDE
GLYCERYL ISOSTEARATE
ISOSTEARYL ALCOHOL
MYRISTYL MYRISTATE
propylene glycol
Neopentyl Glycol Dicaprate
SHEA BUTTER
DIPALMITOYL HYDROXYPROLINE
GLYCERIN
ISOPROPYL MYRISTATE
PEPPERMINT OIL
BRASSICA RAPA VAR. RAPA OIL
.BETA.-SITOSTEROL
saccharin sodium
PHENOXYETHANOL
ETHYL MENTHANE CARBOXAMIDE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
MICA
BRAZILIAN PEPPER
PROPYLPARABEN
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
DIMETHICONE
D&C RED NO. 7
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
D&C RED NO. 27
titanium dioxide
FD&C YELLOW NO. 5
D&c Red No. 21
BRAZIL NUT OIL
BABASSU OIL
POLYETHYLENE GLYCOL 2000
cetearyl ethylhexanoate
water
COCONUT OIL
OLEYL ALCOHOL
talc

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

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
castor oil
TRIDECYL TRIMELLITATE
OCTYLDODECANOL
CANDELILLA WAX
carnauba wax
TRIDECYL STEARATE
CETYL ALCOHOL
Menthyl Lactate
SILICON DIOXIDE
GLYCERYL ISOSTEARATE
ISOSTEARYL ALCOHOL
MYRISTYL MYRISTATE
propylene glycol
Neopentyl Glycol Dicaprate
SHEA BUTTER
DIPALMITOYL HYDROXYPROLINE
GLYCERIN
ISOPROPYL MYRISTATE
PEPPERMINT OIL
BRASSICA RAPA VAR. RAPA OIL
.BETA.-SITOSTEROL
saccharin sodium
PHENOXYETHANOL
ETHYL MENTHANE CARBOXAMIDE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
MICA
BRAZILIAN PEPPER
PROPYLPARABEN
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
DIMETHICONE
D&C RED NO. 7
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
D&C RED NO. 27
titanium dioxide
FD&C YELLOW NO. 5
D&c Red No. 21
BRAZIL NUT OIL
BABASSU OIL
POLYETHYLENE GLYCOL 2000
cetearyl ethylhexanoate
water
COCONUT OIL
OLEYL ALCOHOL
talc

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

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
castor oil
TRIDECYL TRIMELLITATE
OCTYLDODECANOL
CANDELILLA WAX
carnauba wax
TRIDECYL STEARATE
CETYL ALCOHOL
Menthyl Lactate
SILICON DIOXIDE
GLYCERYL ISOSTEARATE
ISOSTEARYL ALCOHOL
MYRISTYL MYRISTATE
propylene glycol
Neopentyl Glycol Dicaprate
SHEA BUTTER
DIPALMITOYL HYDROXYPROLINE
GLYCERIN
ISOPROPYL MYRISTATE
PEPPERMINT OIL
BRASSICA RAPA VAR. RAPA OIL
.BETA.-SITOSTEROL
saccharin sodium
PHENOXYETHANOL
ETHYL MENTHANE CARBOXAMIDE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
MICA
BRAZILIAN PEPPER
PROPYLPARABEN
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
DIMETHICONE
D&C RED NO. 7
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
D&C RED NO. 27
titanium dioxide
FD&C YELLOW NO. 5
D&c Red No. 21
BRAZIL NUT OIL
BABASSU OIL
POLYETHYLENE GLYCOL 2000
cetearyl ethylhexanoate
water
COCONUT OIL
OLEYL ALCOHOL
talc

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


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Be sure to consult your doctor before taking any medication!
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