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esika

Ventura Corporation Ltd.

ēsika Maximum Color Lipstick SPF 18


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

Octinoxate 7.3 %, Oxybenzone 1.65%

Purpose

Sunscreen

esika 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 damage 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.
  • Children under 6 months of age: Ask a doctor.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.

esika Other information

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

diisopropyl dimer dilinoleate, ethylhexyl palmitate, ozokerite, copernicia cerifera (carnauba) wax, polyethylene, butyrospermum parkii (shea) butter, silica, octyldodecanol, water, phenoxyethanol, microcrystalline wax, petrolatum, phospholipids, methylparaben, fragrance, bht, cholesterol, butylparaben, ethylparaben, euphorbia cerifera (candelilla) wax, beeswax, cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, isobutylparaben, propylparaben, glycosphingolipids, maltodextrin, zea mays (corn) starch, sodium hyaluronate. May contain: red 7 lake, red 27 lake, iron oxides, mica, yellow 5 lake, titanium dioxide, red 6 lake, isononyl isononanoate, talc, isopropyl myristate, blue 1 lake, carmine, isopropyl titanium triisostearate, triethoxycaprylylsilane, stearalkonium hectorite, C9-15 fluoroalcohol phosphate, polyhydroxystearic acid, propylene carbonate.

Dist. by Ventura Corporation, Ltd.
San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 4 g Tube Carton

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

esika

esika

OCTINOXATE and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-442
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.073 g
OXYBENZONE OXYBENZONE 0.0165 g

Inactive Ingredients

Ingredient Name Strength
Diisopropyl Dilinoleate
ETHYLHEXYL PALMITATE
carnauba wax
HIGH DENSITY POLYETHYLENE
SHEA BUTTER
SILICON DIOXIDE
OCTYLDODECANOL
water
PHENOXYETHANOL
MICROCRYSTALLINE WAX
petrolatum
METHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
isobutylparaben
PROPYLPARABEN
maltodextrin
STARCH, CORN
HYALURONATE SODIUM
D&C RED NO. 7
D&C RED NO. 27
MICA
FD&C YELLOW NO. 5
titanium dioxide
D&C RED NO. 6
ISONONYL ISONONANOATE
talc
ISOPROPYL MYRISTATE
FD&C BLUE NO. 1
ISOPROPYL TITANIUM TRIISOSTEARATE
TRIETHOXYCAPRYLYLSILANE
PROPYLENE CARBONATE
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-442-01 4 in 1 TUBE
2 NDC:13537-442-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-12-06


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