ESIKA Extreme Moisturizing SPF 16 description, usages, side effects, indications, overdosage, supplying and lots more!

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ESIKA Extreme Moisturizing SPF 16

Ventura Corporation LTD

ĒSIKA Extreme Moisturizing Lipstick SPF 16


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients Purpose
Octinoxate 6.6% Sunscreen
Oxybenzone 1.5 % Sunscreen

ESIKA Extreme Moisturizing SPF 16 Uses

  • Helps prevent sunburn.

Warnings

  • Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
  • For external use only.
  • Do not use on damaged or broken skin.
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: Ask a doctor

ESIKA Extreme Moisturizing SPF 16 Other information

  • Protect the product in this container from excessive heat and direct sun.
  • Apply lipstick following the curves of natural lip line. For added definition, use with a lip penCIl.

Inactive ingredients

Dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, ethylhexyl palmitate, ozokerite, polyethylene, polymethyl methacrylate,water, polyglyceryl-3 diisostearate, tridecyl stearate, copernicia cerifera (carnauba) wax, glycerin, neopentyl glycol dicaprylate/dicaprate, kaolin, octyldodecanol, phenoxyethanol, sodium starch octenylsuccinate, tocopheryl acetate, microcrystalline wax, fragrance, methylparaben, petrolatum, phospholipids, propylparaben, cholesterol, butyrospermum parkii (shea) butter, glycine soja (soybean) oil, butylparaben, ethylparaben, bht,euphorbia cerifera (candelilla) wax, beeswax, cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, isobutylparaben, tocopherol, glycosphingolipids, magnesium chloride, potassium chloride, hydrated silica, sodium chloride.

May contain: red 7 lake , mica, iron oxides, titanium dioxide, bismuth oxychloride, iron oxides, red 21 lake, yellow 5 lake, iron oxides, red 27 lake , talc, blue 1 lake, chitosan, carmine.

PR: Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Borgona Sexy - Brown

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Café Moca - Brown

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Coral Chic - Pink

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Fucsia Cautivante - Purple

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Fucsia Glam - Purple

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Granate Seductor - Purple

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Magenta Traviesa - Purple

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Marron Glamour - Brown

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Morado Exuberante - Purple

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Naranja Primavera - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rojo Deseo - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rojo Intrigante - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rojo Lujuria - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rosa Diva - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rosa Encanto - Pink

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rosa Esplendor - Pink

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rosa Romántica - Pink

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Cereza Hechizo - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Frambuesa Manía - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rosa Dulzura - Pink

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Pimienta Caliente - Brown

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

ESIKA Extreme Moisturizing SPF 16

ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-277
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-277-01 4 in 1 TUBE
2 NDC:13537-277-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-278
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-278-03 4 in 1 TUBE
2 NDC:13537-278-04 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-379
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-379-05 4 in 1 TUBE
2 NDC:13537-379-06 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-280
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-280-07 4 in 1 TUBE
2 NDC:13537-280-08 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-281
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-281-09 4 in 1 TUBE
2 NDC:13537-281-10 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-282
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-282-11 4 in 1 TUBE
2 NDC:13537-282-12 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-283
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-283-13 4 in 1 TUBE
2 NDC:13537-283-14 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-284
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-284-15 4 in 1 TUBE
2 NDC:13537-284-16 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-285
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-285-17 4 in 1 TUBE
2 NDC:13537-285-18 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-286
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-286-19 4 in 1 TUBE
2 NDC:13537-286-20 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-287
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-287-21 4 in 1 TUBE
2 NDC:13537-287-22 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-288
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-288-23 4 in 1 TUBE
2 NDC:13537-288-24 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-289
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-289-25 4 in 1 TUBE
2 NDC:13537-289-26 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-290
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-290-27 4 in 1 TUBE
2 NDC:13537-290-28 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-291
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-291-29 4 in 1 TUBE
2 NDC:13537-291-30 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-292
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-292-31 4 in 1 TUBE
2 NDC:13537-292-32 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-293
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-293-33 4 in 1 TUBE
2 NDC:13537-293-34 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-294
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-294-35 4 in 1 TUBE
2 NDC:13537-294-36 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-295
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-295-37 4 in 1 TUBE
2 NDC:13537-295-38 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-296
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-296-39 4 in 1 TUBE
2 NDC:13537-296-40 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


ESIKA Extreme Moisturizing SPF 16

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-297
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.066 g
OXYBENZONE OXYBENZONE 0.015 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
HIGH DENSITY POLYETHYLENE
water
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SHEA BUTTER
SOYBEAN OIL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
CETEARYL GLUCOSIDE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
HYDRATED SILICA
SODIUM CHLORIDE
D&C RED NO. 7
MICA
titanium dioxide
BISMUTH OXYCHLORIDE
D&c Red No. 21
FD&C YELLOW NO. 5
D&C RED NO. 27
FD&C BLUE NO. 1
talc
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-297-41 4 in 1 TUBE
2 NDC:13537-297-42 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-16


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