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ESIKA

Ventura Corporation (San Juan, P.R)

PERFECT SKIN COVERAGE CONCEALER SPF 17


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

Titanium dioxide 4%

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 lightly on the area you wish to cover.

Inactive Ingredients

Ethylhexyl palmitate, C12-15 alkyl benzoate, caprylic/capric triglyceride, mica, di-ppg-3 myristyl ether adipate, sorbitan isostearate, ozokerite, polyethylene, copernicia cerifera cera (copernicia cerifera (carnauba) wax), polymethyl methacrylate, zea mays (corn) starch, cera alba (beeswax), calendula officinalis flower oil, phenoxyethanol, chitosan, methylparaben, dimethicone, parfum (fragrance), peg-40 hydrogenated castor oil, polysorbate 80, ppg-26-buteth-26, butylparaben, C9-13 fluoroalcohol, ethylparaben, hedera helix extract (hedera helix (ivy) leaf/stem extract), trimethylsiloxysilicate, phosphoric acid, isobutylparaben, propylparaben, tocopheryl acetate, retinyl palmitate, ascorbyl palmitate, bioflavonoids, allantoin, CI 77891 (titanium dioxide), CI 77491 (iron oxides), CI 77492 (iron oxides), CI 77499 (iron oxides).

Dist. by Ventura International Ltd. San Francisco, CA 94111.

PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 1

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 2

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 3

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 4

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 5

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 6

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 1

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 2

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 3

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 4

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 5

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

ESIKA

PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 6

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

ESIKA

ESIKA

Titanium Dioxide STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-037
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 0.04 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
ALKYL (C12-15) BENZOATE
MEDIUM-CHAIN TRIGLYCERIDES
MICA
DI-PPG-3 MYRISTYL ETHER ADIPATE
HIGH DENSITY POLYETHYLENE
carnauba wax
STARCH, CORN
YELLOW WAX
CALENDULA OFFICINALIS FLOWER
PHENOXYETHANOL
METHYLPARABEN
DIMETHICONE
POLYOXYL 40 HYDROGENATED CASTOR OIL
polysorbate 80
BUTYLPARABEN
ETHYLPARABEN
hedera helix top
phosphoric acid
isobutylparaben
PROPYLPARABEN
VITAMIN A PALMITATE
ASCORBYL PALMITATE
ALLANTOIN
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

Product Characteristics

Color
BROWN (BEIGE 1)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-037-01 2 in 1 TUBE
2 NDC:13537-037-02 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

Titanium Dioxide STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-038
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 0.04 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
ALKYL (C12-15) BENZOATE
MEDIUM-CHAIN TRIGLYCERIDES
MICA
DI-PPG-3 MYRISTYL ETHER ADIPATE
HIGH DENSITY POLYETHYLENE
carnauba wax
STARCH, CORN
YELLOW WAX
CALENDULA OFFICINALIS FLOWER
PHENOXYETHANOL
METHYLPARABEN
DIMETHICONE
POLYOXYL 40 HYDROGENATED CASTOR OIL
polysorbate 80
BUTYLPARABEN
ETHYLPARABEN
hedera helix top
phosphoric acid
isobutylparaben
PROPYLPARABEN
VITAMIN A PALMITATE
ASCORBYL PALMITATE
ALLANTOIN
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

Product Characteristics

Color
BROWN (BEIGE 2)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-038-01 2 in 1 TUBE
2 NDC:13537-038-02 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

Titanium Dioxide STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-039
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 0.04 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
ALKYL (C12-15) BENZOATE
MEDIUM-CHAIN TRIGLYCERIDES
MICA
DI-PPG-3 MYRISTYL ETHER ADIPATE
HIGH DENSITY POLYETHYLENE
carnauba wax
STARCH, CORN
YELLOW WAX
CALENDULA OFFICINALIS FLOWER
PHENOXYETHANOL
METHYLPARABEN
DIMETHICONE
POLYOXYL 40 HYDROGENATED CASTOR OIL
polysorbate 80
BUTYLPARABEN
ETHYLPARABEN
hedera helix top
phosphoric acid
isobutylparaben
PROPYLPARABEN
VITAMIN A PALMITATE
ASCORBYL PALMITATE
ALLANTOIN
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

Product Characteristics

Color
BROWN (BEIGE 3)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-039-01 2 in 1 TUBE
2 NDC:13537-039-02 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

Titanium Dioxide STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-040
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 0.04 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
ALKYL (C12-15) BENZOATE
MEDIUM-CHAIN TRIGLYCERIDES
MICA
DI-PPG-3 MYRISTYL ETHER ADIPATE
HIGH DENSITY POLYETHYLENE
carnauba wax
STARCH, CORN
YELLOW WAX
CALENDULA OFFICINALIS FLOWER
PHENOXYETHANOL
METHYLPARABEN
DIMETHICONE
POLYOXYL 40 HYDROGENATED CASTOR OIL
polysorbate 80
BUTYLPARABEN
ETHYLPARABEN
hedera helix top
phosphoric acid
isobutylparaben
PROPYLPARABEN
VITAMIN A PALMITATE
ASCORBYL PALMITATE
ALLANTOIN
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

Product Characteristics

Color
BROWN (BEIGE 4)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-040-01 2 in 1 TUBE
2 NDC:13537-040-02 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

Titanium Dioxide STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-041
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 0.04 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
ALKYL (C12-15) BENZOATE
MEDIUM-CHAIN TRIGLYCERIDES
MICA
DI-PPG-3 MYRISTYL ETHER ADIPATE
HIGH DENSITY POLYETHYLENE
carnauba wax
STARCH, CORN
YELLOW WAX
CALENDULA OFFICINALIS FLOWER
PHENOXYETHANOL
METHYLPARABEN
DIMETHICONE
POLYOXYL 40 HYDROGENATED CASTOR OIL
polysorbate 80
BUTYLPARABEN
ETHYLPARABEN
hedera helix top
phosphoric acid
isobutylparaben
PROPYLPARABEN
VITAMIN A PALMITATE
ASCORBYL PALMITATE
ALLANTOIN
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

Product Characteristics

Color
BROWN (BEIGE 5)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-041-01 2 in 1 TUBE
2 NDC:13537-041-02 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

Titanium Dioxide STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-042
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 0.04 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
ALKYL (C12-15) BENZOATE
MEDIUM-CHAIN TRIGLYCERIDES
MICA
DI-PPG-3 MYRISTYL ETHER ADIPATE
HIGH DENSITY POLYETHYLENE
carnauba wax
STARCH, CORN
YELLOW WAX
CALENDULA OFFICINALIS FLOWER
PHENOXYETHANOL
METHYLPARABEN
DIMETHICONE
POLYOXYL 40 HYDROGENATED CASTOR OIL
polysorbate 80
BUTYLPARABEN
ETHYLPARABEN
hedera helix top
phosphoric acid
isobutylparaben
PROPYLPARABEN
VITAMIN A PALMITATE
ASCORBYL PALMITATE
ALLANTOIN
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

Product Characteristics

Color
BROWN (BEIGE 6)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-042-01 2 in 1 TUBE
2 NDC:13537-042-02 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

Titanium Dioxide STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-043
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 0.04 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
ALKYL (C12-15) BENZOATE
MEDIUM-CHAIN TRIGLYCERIDES
MICA
DI-PPG-3 MYRISTYL ETHER ADIPATE
HIGH DENSITY POLYETHYLENE
carnauba wax
STARCH, CORN
YELLOW WAX
CALENDULA OFFICINALIS FLOWER
PHENOXYETHANOL
METHYLPARABEN
DIMETHICONE
POLYOXYL 40 HYDROGENATED CASTOR OIL
polysorbate 80
BUTYLPARABEN
ETHYLPARABEN
hedera helix top
phosphoric acid
isobutylparaben
PROPYLPARABEN
VITAMIN A PALMITATE
ASCORBYL PALMITATE
ALLANTOIN
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

Product Characteristics

Color
RED (ROSA 1)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-043-01 2 in 1 TUBE
2 NDC:13537-043-02 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

Titanium Dioxide STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-044
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 0.04 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
ALKYL (C12-15) BENZOATE
MEDIUM-CHAIN TRIGLYCERIDES
MICA
DI-PPG-3 MYRISTYL ETHER ADIPATE
HIGH DENSITY POLYETHYLENE
carnauba wax
STARCH, CORN
YELLOW WAX
CALENDULA OFFICINALIS FLOWER
PHENOXYETHANOL
METHYLPARABEN
DIMETHICONE
POLYOXYL 40 HYDROGENATED CASTOR OIL
polysorbate 80
BUTYLPARABEN
ETHYLPARABEN
hedera helix top
phosphoric acid
isobutylparaben
PROPYLPARABEN
VITAMIN A PALMITATE
ASCORBYL PALMITATE
ALLANTOIN
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

Product Characteristics

Color
RED (ROSA 2)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-044-01 2 in 1 TUBE
2 NDC:13537-044-02 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

Titanium Dioxide STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-045
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 0.04 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
ALKYL (C12-15) BENZOATE
MEDIUM-CHAIN TRIGLYCERIDES
MICA
DI-PPG-3 MYRISTYL ETHER ADIPATE
HIGH DENSITY POLYETHYLENE
carnauba wax
STARCH, CORN
YELLOW WAX
CALENDULA OFFICINALIS FLOWER
PHENOXYETHANOL
METHYLPARABEN
DIMETHICONE
POLYOXYL 40 HYDROGENATED CASTOR OIL
polysorbate 80
BUTYLPARABEN
ETHYLPARABEN
hedera helix top
phosphoric acid
isobutylparaben
PROPYLPARABEN
VITAMIN A PALMITATE
ASCORBYL PALMITATE
ALLANTOIN
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

Product Characteristics

Color
RED (ROSA 3)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-045-01 2 in 1 TUBE
2 NDC:13537-045-02 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

Titanium Dioxide STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-046
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 0.04 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
ALKYL (C12-15) BENZOATE
MEDIUM-CHAIN TRIGLYCERIDES
MICA
DI-PPG-3 MYRISTYL ETHER ADIPATE
HIGH DENSITY POLYETHYLENE
carnauba wax
STARCH, CORN
YELLOW WAX
CALENDULA OFFICINALIS FLOWER
PHENOXYETHANOL
METHYLPARABEN
DIMETHICONE
POLYOXYL 40 HYDROGENATED CASTOR OIL
polysorbate 80
BUTYLPARABEN
ETHYLPARABEN
hedera helix top
phosphoric acid
isobutylparaben
PROPYLPARABEN
VITAMIN A PALMITATE
ASCORBYL PALMITATE
ALLANTOIN
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

Product Characteristics

Color
RED (ROSA 4)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-046-01 2 in 1 TUBE
2 NDC:13537-046-02 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

Titanium Dioxide STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-047
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 0.04 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
ALKYL (C12-15) BENZOATE
MEDIUM-CHAIN TRIGLYCERIDES
MICA
DI-PPG-3 MYRISTYL ETHER ADIPATE
HIGH DENSITY POLYETHYLENE
carnauba wax
STARCH, CORN
YELLOW WAX
CALENDULA OFFICINALIS FLOWER
PHENOXYETHANOL
METHYLPARABEN
DIMETHICONE
POLYOXYL 40 HYDROGENATED CASTOR OIL
polysorbate 80
BUTYLPARABEN
ETHYLPARABEN
hedera helix top
phosphoric acid
isobutylparaben
PROPYLPARABEN
VITAMIN A PALMITATE
ASCORBYL PALMITATE
ALLANTOIN
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

Product Characteristics

Color
RED (ROSA 5)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-047-01 2 in 1 TUBE
2 NDC:13537-047-02 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

Titanium Dioxide STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-048
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 0.04 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
ALKYL (C12-15) BENZOATE
MEDIUM-CHAIN TRIGLYCERIDES
MICA
DI-PPG-3 MYRISTYL ETHER ADIPATE
HIGH DENSITY POLYETHYLENE
carnauba wax
STARCH, CORN
YELLOW WAX
CALENDULA OFFICINALIS FLOWER
PHENOXYETHANOL
METHYLPARABEN
DIMETHICONE
POLYOXYL 40 HYDROGENATED CASTOR OIL
polysorbate 80
BUTYLPARABEN
ETHYLPARABEN
hedera helix top
phosphoric acid
isobutylparaben
PROPYLPARABEN
VITAMIN A PALMITATE
ASCORBYL PALMITATE
ALLANTOIN
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

Product Characteristics

Color
RED (ROSA 6)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-048-01 2 in 1 TUBE
2 NDC:13537-048-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-09-23


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