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ESIKA

Ventura Corporation LTD

ESIKA PROTECTOR AGAINST SOLAR RAYS FOR CHILDREN, FACE AND BODY SPF 50


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients Purpose
Ensulizole (3%) Sunscreen
Octinoxate (7.5%) Sunscreen
Octisalate (5%) Sunscreen
Octocrylene (7%) Sunscreen
Oxybenzone (6%) Sunscreen
Titanium Dioxide (4.7%) 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 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 Other information

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

Inactive ingredients

Aqua (water), arginine, butylparaben, ceteareth-20, cetearyl alcohol, cyclohexasiloxane, cyclopentasiloxane, dicaprylyl carbonate, dimethicone, disodium lauriminodipropionate tocopheryl phosphates, ethylparaben, glyceryl stearate, isobutylparaben, methicone, methyl methacrylate crosspolymer, methylparaben, parfum (fragrance), phenethyl benzoate, phenoxyethanol, potassium cetyl phosphate, propylparaben, silica, sorbitan stearate, trimethylsiloxysilicate, vp/eicosene copolymer, xanthan gum.

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

PRINCIPAL DISPLAY PANEL - 80 ml Bottle Label

SPF
50

Perfect
sun
Kids

Sunscreen

protector against solar
rays for children, face and
body SPF 50

ēsika

80 ml e (2.7 fl.oz.)

ESIKA

ESIKA

Ensulizole, Octinoxate, Octisalate, Octocrylene, Oxybenzone, and Titanium Dioxide LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-224
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Ensulizole Ensulizole 0.03 g
OCTINOXATE OCTINOXATE 0.075 g
OCTISALATE OCTISALATE 0.05 g
OCTOCRYLENE Octocrylene 0.07 g
OXYBENZONE OXYBENZONE 0.06 g
titanium dioxide 0.046 g

Inactive Ingredients

Ingredient Name Strength
water
ARGININE
BUTYLPARABEN
POLYOXYL 20 CETOSTEARYL ETHER
CETOSTEARYL ALCOHOL
CYCLOMETHICONE 6
CYCLOMETHICONE 5
DICAPRYLYL CARBONATE
DIMETHICONE
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES
ETHYLPARABEN
GLYCERYL MONOSTEARATE
isobutylparaben
METHYLPARABEN
phenethyl benzoate
PHENOXYETHANOL
potassium cetyl phosphate
PROPYLPARABEN
SILICON DIOXIDE
SORBITAN MONOSTEARATE
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-224-01 80 in 1 BOTTLE, PLASTIC

Marketing Information

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


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