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ESIKA

Ventura Corporation (San Juan, P.R)

ēsika 3-in-1 Pro Make Up Foundation SPF 20


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

Octinoxate (7%), Oxybenzone (2%), Titanium Dioxide (2%)

Purpose

Sunscreen

ESIKA Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • provides moderate protection against sunburn

Warnings

  • For external use only.
  • 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 smootly every morning before sun exposure and as needed.
  • apply evenly on face and neck using a latex pad. Touch up when necessary.
  • 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

Isostearyl neopentanoate, C12-15 alkyl benzoate, polymethyl methacrylate, corn starch, silica, mica, ethylhexyl palmitate, ozokerite, copernicia cerifera cera (copernicia cerifera (carnauba) wax), phenoxyethanol, octyldodecanol, trimethylsiloxysilicate, dimethicone, methylparaben, tocopheryl acetate, microcrystalline wax, propylparaben, petrolatum, phospholipids, bht, c9-13 fluoroalcohol, butylparaben, ethylparaben, phosphoric acid, cholesterol, isobutylparaben, candelilla cera (euphorbia cerifera (candelilla) wax), cera alba (beeswax), cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, glycosphingolipids, chitosan, ci 77492 (iron oxides), ci 77491 (iron oxides), ci 77499 (iron oxides).

PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 1

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 2

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 3

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 4

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 5

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 6

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 1

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 2

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 3

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 4

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 5

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 6

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

ESIKA

ESIKA

Octinoxate, Oxybenzone, and Titanium Dioxide POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-329
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.07 g
OXYBENZONE OXYBENZONE 0.02 g
titanium dioxide 0.02 g

Inactive Ingredients

Ingredient Name Strength
ALKYL (C12-15) BENZOATE
STARCH, CORN
SILICON DIOXIDE
MICA
ETHYLHEXYL PALMITATE
Ceresin
carnauba wax
PHENOXYETHANOL
OCTYLDODECANOL
DIMETHICONE
METHYLPARABEN
MICROCRYSTALLINE WAX
PROPYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
BUTYLPARABEN
ETHYLPARABEN
phosphoric acid
CHOLESTEROL
isobutylparaben
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
FERRIC OXIDE YELLOW
ferric oxide red
FERROSOFERRIC OXIDE

Product Characteristics

Color
BROWN (Beige 1)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-329-01 6 in 1 CASE
2 NDC:13537-329-02 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, Oxybenzone, and Titanium Dioxide POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-330
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.07 g
OXYBENZONE OXYBENZONE 0.02 g
titanium dioxide 0.02 g

Inactive Ingredients

Ingredient Name Strength
ALKYL (C12-15) BENZOATE
STARCH, CORN
SILICON DIOXIDE
MICA
ETHYLHEXYL PALMITATE
Ceresin
carnauba wax
PHENOXYETHANOL
OCTYLDODECANOL
DIMETHICONE
METHYLPARABEN
MICROCRYSTALLINE WAX
PROPYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
BUTYLPARABEN
ETHYLPARABEN
phosphoric acid
CHOLESTEROL
isobutylparaben
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
FERRIC OXIDE YELLOW
ferric oxide red
FERROSOFERRIC OXIDE

Product Characteristics

Color
BROWN (Beige 2)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-330-01 6 in 1 CASE
2 NDC:13537-330-02 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, Oxybenzone, and Titanium Dioxide POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-331
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.07 g
OXYBENZONE OXYBENZONE 0.02 g
titanium dioxide 0.02 g

Inactive Ingredients

Ingredient Name Strength
ALKYL (C12-15) BENZOATE
STARCH, CORN
SILICON DIOXIDE
MICA
ETHYLHEXYL PALMITATE
Ceresin
carnauba wax
PHENOXYETHANOL
OCTYLDODECANOL
DIMETHICONE
METHYLPARABEN
MICROCRYSTALLINE WAX
PROPYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
BUTYLPARABEN
ETHYLPARABEN
phosphoric acid
CHOLESTEROL
isobutylparaben
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
FERRIC OXIDE YELLOW
ferric oxide red
FERROSOFERRIC OXIDE

Product Characteristics

Color
BROWN (Beige 3)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-331-01 6 in 1 CASE
2 NDC:13537-331-02 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, Oxybenzone, and Titanium Dioxide POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-332
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.07 g
OXYBENZONE OXYBENZONE 0.02 g
titanium dioxide 0.02 g

Inactive Ingredients

Ingredient Name Strength
ALKYL (C12-15) BENZOATE
STARCH, CORN
SILICON DIOXIDE
MICA
ETHYLHEXYL PALMITATE
Ceresin
carnauba wax
PHENOXYETHANOL
OCTYLDODECANOL
DIMETHICONE
METHYLPARABEN
MICROCRYSTALLINE WAX
PROPYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
BUTYLPARABEN
ETHYLPARABEN
phosphoric acid
CHOLESTEROL
isobutylparaben
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
FERRIC OXIDE YELLOW
ferric oxide red
FERROSOFERRIC OXIDE

Product Characteristics

Color
BROWN (Beige 4)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-332-01 6 in 1 CASE
2 NDC:13537-332-02 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, Oxybenzone, and Titanium Dioxide POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-333
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.07 g
OXYBENZONE OXYBENZONE 0.02 g
titanium dioxide 0.02 g

Inactive Ingredients

Ingredient Name Strength
ALKYL (C12-15) BENZOATE
STARCH, CORN
SILICON DIOXIDE
MICA
ETHYLHEXYL PALMITATE
Ceresin
carnauba wax
PHENOXYETHANOL
OCTYLDODECANOL
DIMETHICONE
METHYLPARABEN
MICROCRYSTALLINE WAX
PROPYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
BUTYLPARABEN
ETHYLPARABEN
phosphoric acid
CHOLESTEROL
isobutylparaben
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
FERRIC OXIDE YELLOW
ferric oxide red
FERROSOFERRIC OXIDE

Product Characteristics

Color
BROWN (Beige 5)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-333-01 6 in 1 CASE
2 NDC:13537-333-02 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, Oxybenzone, and Titanium Dioxide POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-334
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.07 g
OXYBENZONE OXYBENZONE 0.02 g
titanium dioxide 0.02 g

Inactive Ingredients

Ingredient Name Strength
ALKYL (C12-15) BENZOATE
STARCH, CORN
SILICON DIOXIDE
MICA
ETHYLHEXYL PALMITATE
Ceresin
carnauba wax
PHENOXYETHANOL
OCTYLDODECANOL
DIMETHICONE
METHYLPARABEN
MICROCRYSTALLINE WAX
PROPYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
BUTYLPARABEN
ETHYLPARABEN
phosphoric acid
CHOLESTEROL
isobutylparaben
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
FERRIC OXIDE YELLOW
ferric oxide red
FERROSOFERRIC OXIDE

Product Characteristics

Color
BROWN (Beige 6)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-334-01 6 in 1 CASE
2 NDC:13537-334-02 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, Oxybenzone, and Titanium Dioxide POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-335
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.07 g
OXYBENZONE OXYBENZONE 0.02 g
titanium dioxide 0.02 g

Inactive Ingredients

Ingredient Name Strength
ALKYL (C12-15) BENZOATE
STARCH, CORN
SILICON DIOXIDE
MICA
ETHYLHEXYL PALMITATE
Ceresin
carnauba wax
PHENOXYETHANOL
OCTYLDODECANOL
DIMETHICONE
METHYLPARABEN
MICROCRYSTALLINE WAX
PROPYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
BUTYLPARABEN
ETHYLPARABEN
phosphoric acid
CHOLESTEROL
isobutylparaben
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
FERRIC OXIDE YELLOW
ferric oxide red
FERROSOFERRIC OXIDE

Product Characteristics

Color
RED (Rosa 1)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-335-01 6 in 1 CASE
2 NDC:13537-335-02 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, Oxybenzone, and Titanium Dioxide POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-336
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.07 g
OXYBENZONE OXYBENZONE 0.02 g
titanium dioxide 0.02 g

Inactive Ingredients

Ingredient Name Strength
ALKYL (C12-15) BENZOATE
STARCH, CORN
SILICON DIOXIDE
MICA
ETHYLHEXYL PALMITATE
Ceresin
carnauba wax
PHENOXYETHANOL
OCTYLDODECANOL
DIMETHICONE
METHYLPARABEN
MICROCRYSTALLINE WAX
PROPYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
BUTYLPARABEN
ETHYLPARABEN
phosphoric acid
CHOLESTEROL
isobutylparaben
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
FERRIC OXIDE YELLOW
ferric oxide red
FERROSOFERRIC OXIDE

Product Characteristics

Color
RED (Rosa 2)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-336-01 6 in 1 CASE
2 NDC:13537-336-02 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, Oxybenzone, and Titanium Dioxide POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-337
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.07 g
OXYBENZONE OXYBENZONE 0.02 g
titanium dioxide 0.02 g

Inactive Ingredients

Ingredient Name Strength
ALKYL (C12-15) BENZOATE
STARCH, CORN
SILICON DIOXIDE
MICA
ETHYLHEXYL PALMITATE
Ceresin
carnauba wax
PHENOXYETHANOL
OCTYLDODECANOL
DIMETHICONE
METHYLPARABEN
MICROCRYSTALLINE WAX
PROPYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
BUTYLPARABEN
ETHYLPARABEN
phosphoric acid
CHOLESTEROL
isobutylparaben
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
FERRIC OXIDE YELLOW
ferric oxide red
FERROSOFERRIC OXIDE

Product Characteristics

Color
RED (Rosa 3)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-337-01 6 in 1 CASE
2 NDC:13537-337-02 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, Oxybenzone, and Titanium Dioxide POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-338
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.07 g
OXYBENZONE OXYBENZONE 0.02 g
titanium dioxide 0.02 g

Inactive Ingredients

Ingredient Name Strength
ALKYL (C12-15) BENZOATE
STARCH, CORN
SILICON DIOXIDE
MICA
ETHYLHEXYL PALMITATE
Ceresin
carnauba wax
PHENOXYETHANOL
OCTYLDODECANOL
DIMETHICONE
METHYLPARABEN
MICROCRYSTALLINE WAX
PROPYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
BUTYLPARABEN
ETHYLPARABEN
phosphoric acid
CHOLESTEROL
isobutylparaben
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
FERRIC OXIDE YELLOW
ferric oxide red
FERROSOFERRIC OXIDE

Product Characteristics

Color
RED (Rosa 4)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-338-01 6 in 1 CASE
2 NDC:13537-338-02 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, Oxybenzone, and Titanium Dioxide POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-339
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.07 g
OXYBENZONE OXYBENZONE 0.02 g
titanium dioxide 0.02 g

Inactive Ingredients

Ingredient Name Strength
ALKYL (C12-15) BENZOATE
STARCH, CORN
SILICON DIOXIDE
MICA
ETHYLHEXYL PALMITATE
Ceresin
carnauba wax
PHENOXYETHANOL
OCTYLDODECANOL
DIMETHICONE
METHYLPARABEN
MICROCRYSTALLINE WAX
PROPYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
BUTYLPARABEN
ETHYLPARABEN
phosphoric acid
CHOLESTEROL
isobutylparaben
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
FERRIC OXIDE YELLOW
ferric oxide red
FERROSOFERRIC OXIDE

Product Characteristics

Color
RED (Rosa 5)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-339-01 6 in 1 CASE
2 NDC:13537-339-02 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, Oxybenzone, and Titanium Dioxide POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-340
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.07 g
OXYBENZONE OXYBENZONE 0.02 g
titanium dioxide 0.02 g

Inactive Ingredients

Ingredient Name Strength
ALKYL (C12-15) BENZOATE
STARCH, CORN
SILICON DIOXIDE
MICA
ETHYLHEXYL PALMITATE
Ceresin
carnauba wax
PHENOXYETHANOL
OCTYLDODECANOL
DIMETHICONE
METHYLPARABEN
MICROCRYSTALLINE WAX
PROPYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
BUTYLPARABEN
ETHYLPARABEN
phosphoric acid
CHOLESTEROL
isobutylparaben
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
FERRIC OXIDE YELLOW
ferric oxide red
FERROSOFERRIC OXIDE

Product Characteristics

Color
RED (Rosa 6)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-340-01 6 in 1 CASE
2 NDC:13537-340-02 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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