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ESIKA

Ventura Corporation LTD

ésika natural care


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients Purpose
OCTINOXATE 7.5% Sunscreen
OXYBENZONE 4.5% 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), GLYCERYL STEARATE, CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, PEG-100 STEARATE, CETYL ALCOHOL, DICAPRYLYL CARBONATE, PROPYLENE GLYCOL, GLYCERIN, PHENOXYETHANOL, CYCLOHEXASILOXANE, DIMETHICONE, METHYLPARABEN, CI 77891 (TITANIUM DIOXIDE ), PAPAIN, TRIETHANOLAMINE, PROPYLPARABEN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM LACTATE, CASTORYL MALEATE, PARFUM (FRAGRANCE), BUTYLENE GLYCOL, TETRASODIUM EDTA, CALCIUM PANTOTHENATE, ARCTOSTAPHYLOS UVA URSI LEAF EXTRACT, XANTHAN GUM, BUTYLPARABEN, ETHYLPARABEN, CAPRYLYL GLYCOL, ROSA MOSCHATA SEED OIL, UREA, MAGNESIUM LACTATE, ETHYLHEXYLGLYCERIN, POTASSIUM LACTATE, ISOBUTYLPARABEN, ALANINE, MAGNESIUM CHLORIDE, PROLINE, SERINE, SODIUM CITRATE, MOTHER OF PEARL EXTRACT.

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

PRINCIPAL DISPLAY PANEL - 60 g Bottle Carton

naturalcare

rosa mosqueta
& concha de nácar

crema aclaradora facial FPS 15

60 g e (2.1 oz.)

ésika

ESIKA

ESIKA

Octinoxate and Oxybenzone CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-152
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.075 g
OXYBENZONE OXYBENZONE 0.045 g

Inactive Ingredients

Ingredient Name Strength
water
GLYCERYL MONOSTEARATE
CYCLOMETHICONE 5
ALKYL (C12-15) BENZOATE
PEG-100 STEARATE
CETYL ALCOHOL
DICAPRYLYL CARBONATE
propylene glycol
GLYCERIN
PHENOXYETHANOL
CYCLOMETHICONE 6
DIMETHICONE
METHYLPARABEN
titanium dioxide
Papain
TROLAMINE
PROPYLPARABEN
sodium lactate
BUTYLENE GLYCOL
EDETATE SODIUM
CALCIUM PANTOTHENATE
arctostaphylos uva-ursi leaf
XANTHAN GUM
BUTYLPARABEN
ETHYLPARABEN
CAPRYLYL GLYCOL
ROSA MOSCHATA SEED OIL
UREA
ETHYLHEXYLGLYCERIN
POTASSIUM LACTATE
isobutylparaben
ALANINE
MAGNESIUM CHLORIDE
PROLINE
SERINE
SODIUM CITRATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE
2 NDC:13537-152-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-01-24


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