ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 description, usages, side effects, indications, overdosage, supplying and lots more!

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ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

Ventura Corporation LTD

ésika HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING LIPSTICK SPF 25


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

OCTINOXATE: 6.64%
OXYBENZONE: 1.51%

Purpose

Sunscreen

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 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. Rinse with water to remove. If swallowed, get medical help or contact a Poison Control Center right away.
  • 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
  • Apply stick following the curves of natural lip line. For added definition, use with a lip pencil

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 Other information

  • Protect this product in this container form excesive heat and direct sun. Keep away from heat sources and direct sunlight. Store well and under 50°C (112°F).

Inactive ingredients

DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TRIDECYL TRIMELLITATE, ETHYLHEXYL PALMITATE, OZOKERITE, AQUA (WATER), POLYETHYLENE, POLYGLYCERYL-3 DIISOSTEARATE, POLYMETHYL METHACRYLATE, TRIDECYL STEARATE, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA ) WAX), GLYCERIN, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SODIUM STARCH OCTENYLSUCCINATE, TOCOPHERYL ACETATE, PHENOXYETHANOL, COCOS NUCIFERA OIL (COCOS NUCIFERA (COCONUT) OIL), ALOE BARBADENSIS LEAF EXTRACT, PARFUM (FRAGRANCE), CAPRYLYL GLYCOL, CERAMIDE 3, CHLORPHENESIN, PROPYLENE GLYCOL, LIMONIUM GERBERI EXTRACT, BUTYROSPERMUM PARKII  BUTTER (BUTYROSPERMUM PARKII (SHEA) BUTTER), GLYCINE SOJA OIL (GLYCINE SOJA (SOYBEAN) OIL ), TOCOPHEROL, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SILICA, SODIUM CHLORIDE, VITIS VINIFERA FRUIT EXTRACT (VITIS VINIFERA (GRAPE) FRUIT EXTRACT), alpha-ISOMETHYL IONONE, D-LIMONENE, LINALOOL, AMYL CINNAMAL, CITRONELLOL.

May contain:
CI 77019 (MICA), CI 77491 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE ), CI 45380 (RED 21 LAKE), CI 19140 (YELLOW 5 LAKE), CI 15850 (RED 7 LAKE), CI 45410 (RED 27 LAKE), CI 77499 (IRON OXIDES), CI 77492 (IRON OXIDES), TALC, PEG-8 METHYL ETHER TRIETHOXYSILANE, CI 75470 (CARMINE).

P.R.: Dist by Ventura Corp, Ltd., San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON GLAMOUR) - BROWN

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
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4 g e (.14 oz.)

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO DESEO) - RED

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO INTRIGANTE) - RED

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO LUJURIA) - RED

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CORAL CHIC) - PINK

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ENCANTO) - PINK

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BORGOÑA SEXY) - PURPLE

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA CAUTIVANTE) - PINK

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (GRANATE SEDUCTOR) - PURPLE

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ROMÁNTICA) - PINK

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NARANJA PRIMAVERA) - ORANGE

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FRAMBUESA MANÍA) - RED

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA DULZURA) - PINK

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (PIMIENTA CALIENTE) - BROWN

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

PRINCIPAL DISPLAY PANEL - 14 Tube Kit

HYDRACOLOR 2 in 1
Highly moisturizing
and coloring LIPSTICK SPF 25

ésika

8 g e (.28 oz.)

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-061
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.0664 g
OXYBENZONE OXYBENZONE 0.0151 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
water
HIGH DENSITY POLYETHYLENE
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
MEDIUM-CHAIN TRIGLYCERIDES
.ALPHA.-TOCOPHEROL ACETATE
PHENOXYETHANOL
COCONUT OIL
Aloe Vera Leaf
CAPRYLYL GLYCOL
CERAMIDE 3
CHLORPHENESIN
propylene glycol
SHEA BUTTER
SOYBEAN OIL
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
SILICON DIOXIDE
SODIUM CHLORIDE
WINE GRAPE
ISOMETHYL-.ALPHA.-IONONE
LIMONENE, (+)-
LINALOOL, (+/-)-
.ALPHA.-AMYLCINNAMALDEHYDE
.BETA.-CITRONELLOL, (R)-
MICA
ferric oxide red
titanium dioxide
D&c Red No. 21
ALUMINUM OXIDE
FD&C YELLOW NO. 5
D&C RED NO. 7
D&C RED NO. 27
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
talc
CARMINIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-061-01 4 in 1 TUBE
2 NDC:13537-061-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-04-03


ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-064
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.0664 g
OXYBENZONE OXYBENZONE 0.0151 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
water
HIGH DENSITY POLYETHYLENE
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
MEDIUM-CHAIN TRIGLYCERIDES
.ALPHA.-TOCOPHEROL ACETATE
PHENOXYETHANOL
COCONUT OIL
Aloe Vera Leaf
CAPRYLYL GLYCOL
CERAMIDE 3
CHLORPHENESIN
propylene glycol
SHEA BUTTER
SOYBEAN OIL
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
SILICON DIOXIDE
SODIUM CHLORIDE
WINE GRAPE
ISOMETHYL-.ALPHA.-IONONE
LIMONENE, (+)-
LINALOOL, (+/-)-
.ALPHA.-AMYLCINNAMALDEHYDE
.BETA.-CITRONELLOL, (R)-
MICA
ferric oxide red
titanium dioxide
D&c Red No. 21
ALUMINUM OXIDE
FD&C YELLOW NO. 5
D&C RED NO. 7
D&C RED NO. 27
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
talc
CARMINIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-064-03 4 in 1 TUBE
2 NDC:13537-064-04 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-04-03


ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-065
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.0664 g
OXYBENZONE OXYBENZONE 0.0151 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
water
HIGH DENSITY POLYETHYLENE
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
MEDIUM-CHAIN TRIGLYCERIDES
.ALPHA.-TOCOPHEROL ACETATE
PHENOXYETHANOL
COCONUT OIL
Aloe Vera Leaf
CAPRYLYL GLYCOL
CERAMIDE 3
CHLORPHENESIN
propylene glycol
SHEA BUTTER
SOYBEAN OIL
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
SILICON DIOXIDE
SODIUM CHLORIDE
WINE GRAPE
ISOMETHYL-.ALPHA.-IONONE
LIMONENE, (+)-
LINALOOL, (+/-)-
.ALPHA.-AMYLCINNAMALDEHYDE
.BETA.-CITRONELLOL, (R)-
MICA
ferric oxide red
titanium dioxide
D&c Red No. 21
ALUMINUM OXIDE
FD&C YELLOW NO. 5
D&C RED NO. 7
D&C RED NO. 27
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
talc
CARMINIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-065-05 4 in 1 TUBE
2 NDC:13537-065-06 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-04-03


ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-066
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.0664 g
OXYBENZONE OXYBENZONE 0.0151 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
water
HIGH DENSITY POLYETHYLENE
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
MEDIUM-CHAIN TRIGLYCERIDES
.ALPHA.-TOCOPHEROL ACETATE
PHENOXYETHANOL
COCONUT OIL
Aloe Vera Leaf
CAPRYLYL GLYCOL
CERAMIDE 3
CHLORPHENESIN
propylene glycol
SHEA BUTTER
SOYBEAN OIL
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
SILICON DIOXIDE
SODIUM CHLORIDE
WINE GRAPE
ISOMETHYL-.ALPHA.-IONONE
LIMONENE, (+)-
LINALOOL, (+/-)-
.ALPHA.-AMYLCINNAMALDEHYDE
.BETA.-CITRONELLOL, (R)-
MICA
ferric oxide red
titanium dioxide
D&c Red No. 21
ALUMINUM OXIDE
FD&C YELLOW NO. 5
D&C RED NO. 7
D&C RED NO. 27
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
talc
CARMINIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-066-07 4 in 1 TUBE
2 NDC:13537-066-08 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-04-03


ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-067
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.0664 g
OXYBENZONE OXYBENZONE 0.0151 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
water
HIGH DENSITY POLYETHYLENE
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
MEDIUM-CHAIN TRIGLYCERIDES
.ALPHA.-TOCOPHEROL ACETATE
PHENOXYETHANOL
COCONUT OIL
Aloe Vera Leaf
CAPRYLYL GLYCOL
CERAMIDE 3
CHLORPHENESIN
propylene glycol
SHEA BUTTER
SOYBEAN OIL
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
SILICON DIOXIDE
SODIUM CHLORIDE
WINE GRAPE
ISOMETHYL-.ALPHA.-IONONE
LIMONENE, (+)-
LINALOOL, (+/-)-
.ALPHA.-AMYLCINNAMALDEHYDE
.BETA.-CITRONELLOL, (R)-
MICA
ferric oxide red
titanium dioxide
D&c Red No. 21
ALUMINUM OXIDE
FD&C YELLOW NO. 5
D&C RED NO. 7
D&C RED NO. 27
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
talc
CARMINIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-067-09 4 in 1 TUBE
2 NDC:13537-067-10 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-04-03


ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-068
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.0664 g
OXYBENZONE OXYBENZONE 0.0151 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
water
HIGH DENSITY POLYETHYLENE
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
MEDIUM-CHAIN TRIGLYCERIDES
.ALPHA.-TOCOPHEROL ACETATE
PHENOXYETHANOL
COCONUT OIL
Aloe Vera Leaf
CAPRYLYL GLYCOL
CERAMIDE 3
CHLORPHENESIN
propylene glycol
SHEA BUTTER
SOYBEAN OIL
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
SILICON DIOXIDE
SODIUM CHLORIDE
WINE GRAPE
ISOMETHYL-.ALPHA.-IONONE
LIMONENE, (+)-
LINALOOL, (+/-)-
.ALPHA.-AMYLCINNAMALDEHYDE
.BETA.-CITRONELLOL, (R)-
MICA
ferric oxide red
titanium dioxide
D&c Red No. 21
ALUMINUM OXIDE
FD&C YELLOW NO. 5
D&C RED NO. 7
D&C RED NO. 27
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
talc
CARMINIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-068-11 4 in 1 TUBE
2 NDC:13537-068-12 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-04-03


ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-069
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.0664 g
OXYBENZONE OXYBENZONE 0.0151 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
water
HIGH DENSITY POLYETHYLENE
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
MEDIUM-CHAIN TRIGLYCERIDES
.ALPHA.-TOCOPHEROL ACETATE
PHENOXYETHANOL
COCONUT OIL
Aloe Vera Leaf
CAPRYLYL GLYCOL
CERAMIDE 3
CHLORPHENESIN
propylene glycol
SHEA BUTTER
SOYBEAN OIL
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
SILICON DIOXIDE
SODIUM CHLORIDE
WINE GRAPE
ISOMETHYL-.ALPHA.-IONONE
LIMONENE, (+)-
LINALOOL, (+/-)-
.ALPHA.-AMYLCINNAMALDEHYDE
.BETA.-CITRONELLOL, (R)-
MICA
ferric oxide red
titanium dioxide
D&c Red No. 21
ALUMINUM OXIDE
FD&C YELLOW NO. 5
D&C RED NO. 7
D&C RED NO. 27
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
talc
CARMINIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-069-13 4 in 1 TUBE
2 NDC:13537-069-14 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-04-03


ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-070
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.0664 g
OXYBENZONE OXYBENZONE 0.0151 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
water
HIGH DENSITY POLYETHYLENE
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
MEDIUM-CHAIN TRIGLYCERIDES
.ALPHA.-TOCOPHEROL ACETATE
PHENOXYETHANOL
COCONUT OIL
Aloe Vera Leaf
CAPRYLYL GLYCOL
CERAMIDE 3
CHLORPHENESIN
propylene glycol
SHEA BUTTER
SOYBEAN OIL
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
SILICON DIOXIDE
SODIUM CHLORIDE
WINE GRAPE
ISOMETHYL-.ALPHA.-IONONE
LIMONENE, (+)-
LINALOOL, (+/-)-
.ALPHA.-AMYLCINNAMALDEHYDE
.BETA.-CITRONELLOL, (R)-
MICA
ferric oxide red
titanium dioxide
D&c Red No. 21
ALUMINUM OXIDE
FD&C YELLOW NO. 5
D&C RED NO. 7
D&C RED NO. 27
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
talc
CARMINIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-070-15 4 in 1 TUBE
2 NDC:13537-070-16 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-04-03


ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-071
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.0664 g
OXYBENZONE OXYBENZONE 0.0151 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
water
HIGH DENSITY POLYETHYLENE
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
MEDIUM-CHAIN TRIGLYCERIDES
.ALPHA.-TOCOPHEROL ACETATE
PHENOXYETHANOL
COCONUT OIL
Aloe Vera Leaf
CAPRYLYL GLYCOL
CERAMIDE 3
CHLORPHENESIN
propylene glycol
SHEA BUTTER
SOYBEAN OIL
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
SILICON DIOXIDE
SODIUM CHLORIDE
WINE GRAPE
ISOMETHYL-.ALPHA.-IONONE
LIMONENE, (+)-
LINALOOL, (+/-)-
.ALPHA.-AMYLCINNAMALDEHYDE
.BETA.-CITRONELLOL, (R)-
MICA
ferric oxide red
titanium dioxide
D&c Red No. 21
ALUMINUM OXIDE
FD&C YELLOW NO. 5
D&C RED NO. 7
D&C RED NO. 27
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
talc
CARMINIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-071-17 4 in 1 TUBE
2 NDC:13537-071-18 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-04-03


ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-072
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.0664 g
OXYBENZONE OXYBENZONE 0.0151 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
water
HIGH DENSITY POLYETHYLENE
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
MEDIUM-CHAIN TRIGLYCERIDES
.ALPHA.-TOCOPHEROL ACETATE
PHENOXYETHANOL
COCONUT OIL
Aloe Vera Leaf
CAPRYLYL GLYCOL
CERAMIDE 3
CHLORPHENESIN
propylene glycol
SHEA BUTTER
SOYBEAN OIL
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
SILICON DIOXIDE
SODIUM CHLORIDE
WINE GRAPE
ISOMETHYL-.ALPHA.-IONONE
LIMONENE, (+)-
LINALOOL, (+/-)-
.ALPHA.-AMYLCINNAMALDEHYDE
.BETA.-CITRONELLOL, (R)-
MICA
ferric oxide red
titanium dioxide
D&c Red No. 21
ALUMINUM OXIDE
FD&C YELLOW NO. 5
D&C RED NO. 7
D&C RED NO. 27
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
talc
CARMINIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-072-19 4 in 1 TUBE
2 NDC:13537-072-20 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-04-03


ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-073
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.0664 g
OXYBENZONE OXYBENZONE 0.0151 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
water
HIGH DENSITY POLYETHYLENE
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
MEDIUM-CHAIN TRIGLYCERIDES
.ALPHA.-TOCOPHEROL ACETATE
PHENOXYETHANOL
COCONUT OIL
Aloe Vera Leaf
CAPRYLYL GLYCOL
CERAMIDE 3
CHLORPHENESIN
propylene glycol
SHEA BUTTER
SOYBEAN OIL
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
SILICON DIOXIDE
SODIUM CHLORIDE
WINE GRAPE
ISOMETHYL-.ALPHA.-IONONE
LIMONENE, (+)-
LINALOOL, (+/-)-
.ALPHA.-AMYLCINNAMALDEHYDE
.BETA.-CITRONELLOL, (R)-
MICA
ferric oxide red
titanium dioxide
D&c Red No. 21
ALUMINUM OXIDE
FD&C YELLOW NO. 5
D&C RED NO. 7
D&C RED NO. 27
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
talc
CARMINIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-073-21 4 in 1 TUBE
2 NDC:13537-073-22 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-04-03


ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-074
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.0664 g
OXYBENZONE OXYBENZONE 0.0151 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
water
HIGH DENSITY POLYETHYLENE
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
MEDIUM-CHAIN TRIGLYCERIDES
.ALPHA.-TOCOPHEROL ACETATE
PHENOXYETHANOL
COCONUT OIL
Aloe Vera Leaf
CAPRYLYL GLYCOL
CERAMIDE 3
CHLORPHENESIN
propylene glycol
SHEA BUTTER
SOYBEAN OIL
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
SILICON DIOXIDE
SODIUM CHLORIDE
WINE GRAPE
ISOMETHYL-.ALPHA.-IONONE
LIMONENE, (+)-
LINALOOL, (+/-)-
.ALPHA.-AMYLCINNAMALDEHYDE
.BETA.-CITRONELLOL, (R)-
MICA
ferric oxide red
titanium dioxide
D&c Red No. 21
ALUMINUM OXIDE
FD&C YELLOW NO. 5
D&C RED NO. 7
D&C RED NO. 27
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
talc
CARMINIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-074-23 4 in 1 TUBE
2 NDC:13537-074-24 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-04-03


ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-075
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.0664 g
OXYBENZONE OXYBENZONE 0.0151 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
water
HIGH DENSITY POLYETHYLENE
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
MEDIUM-CHAIN TRIGLYCERIDES
.ALPHA.-TOCOPHEROL ACETATE
PHENOXYETHANOL
COCONUT OIL
Aloe Vera Leaf
CAPRYLYL GLYCOL
CERAMIDE 3
CHLORPHENESIN
propylene glycol
SHEA BUTTER
SOYBEAN OIL
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
SILICON DIOXIDE
SODIUM CHLORIDE
WINE GRAPE
ISOMETHYL-.ALPHA.-IONONE
LIMONENE, (+)-
LINALOOL, (+/-)-
.ALPHA.-AMYLCINNAMALDEHYDE
.BETA.-CITRONELLOL, (R)-
MICA
ferric oxide red
titanium dioxide
D&c Red No. 21
ALUMINUM OXIDE
FD&C YELLOW NO. 5
D&C RED NO. 7
D&C RED NO. 27
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
talc
CARMINIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-075-25 4 in 1 TUBE
2 NDC:13537-075-26 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-04-03


ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-076
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.0664 g
OXYBENZONE OXYBENZONE 0.0151 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
water
HIGH DENSITY POLYETHYLENE
POLYGLYCERYL-3 DIISOSTEARATE
TRIDECYL STEARATE
carnauba wax
GLYCERIN
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
MEDIUM-CHAIN TRIGLYCERIDES
.ALPHA.-TOCOPHEROL ACETATE
PHENOXYETHANOL
COCONUT OIL
Aloe Vera Leaf
CAPRYLYL GLYCOL
CERAMIDE 3
CHLORPHENESIN
propylene glycol
SHEA BUTTER
SOYBEAN OIL
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
SILICON DIOXIDE
SODIUM CHLORIDE
WINE GRAPE
ISOMETHYL-.ALPHA.-IONONE
LIMONENE, (+)-
LINALOOL, (+/-)-
.ALPHA.-AMYLCINNAMALDEHYDE
.BETA.-CITRONELLOL, (R)-
MICA
ferric oxide red
titanium dioxide
D&c Red No. 21
ALUMINUM OXIDE
FD&C YELLOW NO. 5
D&C RED NO. 7
D&C RED NO. 27
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
talc
CARMINIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-076-27 4 in 1 TUBE
2 NDC:13537-076-28 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-04-03


ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25

Octinoxate and Oxybenzone KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-077
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-077-29 1 in 1 CASE
2 NDC:13537-077-30 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-04-03


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