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Esika

Ventura Corporation (San Juan, P.R)

ēsika


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

Octinoxate (2%), Titanium Dioxide (4.43%)

Purpose

Sunscreen

Esika Uses

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Provides minimum protection against sunburn

Warnings

  • For external use only
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash and irritation develops and lasts.
  • Children under 6 months of age: ask a doctor.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply smootly every morning before sun exposure and as needed.
  • Sun protection product.

Esika Other information

  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Talc, zea mays starch( zea mays (corn) starch), calcium carbonate, silica, zinc stearate, paraffinum liquidum (mineral oil), CI 77019 (mica), dimethicone/methicone copolymer, octyldodecanol, alumina, methylparaben, propylparaben, microcristallina cera (microcrystalline wax), petrolatum, phospholipids, polyethylene, cholesterol, polyglyceryl-2 dipolyhydroxystearate, copernicia cerifera cera (copernicia cerifera (carnauba) wax), candelilla cera (euphorbia cerifera (candelilla) wax), cera alba (beeswax), cetearyl glucoside, cetearyl alcohol, glycosphingolipids. May contain: CI 77491 (iron oxides), CI 77492 (iron oxides), CI 77499 (iron oxides).

PRINCIPAL DISPLAY PANEL - 15 g Carton (Translucido)

ēsika

Silk Skin
Face Powder SPF 9

15 g e (.53 oz.)

Esika

PRINCIPAL DISPLAY PANEL - 15 g Carton (Terracota)

ēsika

Silk Skin
Face Powder SPF 9

15 g e (.53 oz.)

Esika

Esika

OCTINOXATE and TITANIUM DIOXIDE POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-354
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.02 g
titanium dioxide 0.044 g

Inactive Ingredients

Ingredient Name Strength
talc
STARCH, CORN
CALCIUM CARBONATE
SILICON DIOXIDE
ZINC STEARATE
Mineral Oil
MICA
OCTYLDODECANOL
ALUMINUM OXIDE
METHYLPARABEN
PROPYLPARABEN
MICROCRYSTALLINE WAX
petrolatum
CHOLESTEROL
carnauba wax
CANDELILLA WAX
YELLOW WAX
CETEARYL GLUCOSIDE
CETOSTEARYL ALCOHOL
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-354-01 15 in 1 JAR
2 NDC:13537-354-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-07-24


Esika

OCTINOXATE and TITANIUM DIOXIDE POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-355
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.02 g
titanium dioxide 0.044 g

Inactive Ingredients

Ingredient Name Strength
talc
STARCH, CORN
CALCIUM CARBONATE
SILICON DIOXIDE
ZINC STEARATE
Mineral Oil
MICA
OCTYLDODECANOL
ALUMINUM OXIDE
METHYLPARABEN
PROPYLPARABEN
MICROCRYSTALLINE WAX
petrolatum
CHOLESTEROL
carnauba wax
CANDELILLA WAX
YELLOW WAX
CETEARYL GLUCOSIDE
CETOSTEARYL ALCOHOL
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-355-01 15 in 1 JAR
2 NDC:13537-355-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-07-24


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