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EAD

European Perfume Works Co.L.L.C.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

EAD 


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Avobenzone  1.2%

Homosalate   2.0%

Octisalate      5.0%  

Octocrylene   1.0%

Sunscreen

If product is swallowed, get medical help or contact a Poison Control Center right away.

  • helps prevent Sunburn
  • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

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.

  • apply liberally 15 minutes before sun exposure
  • reapply 

     -after 80 minutes of swimming or sweating
     - immediately after towel drying
     - at least every 2 hours

  • Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

     - limit time in the sun, especially from 10 a.m. - 2 p.m.

     - wear long-sleeve shirts, pants, hats, and sunglasses

  • children under 6 months: Ask a doctor

amyl cinnamal, ascorbyl palmitate, benzyl alcohol, butylparaben, C12-15 alkyl benzoate,

carbomer, ceteareth-20, cetearyl alcohol, ethylparaben, fragrance, glyceryl stearate, glyceryl

stearate SE, isobutylparaben, linalool, methylparaben, PEG-100 stearate, phenoxyethanol,

propylene glycol, propylparaben, sodium hydroxide, sodium cetearyl sulfate, tetrasodium

EDTA, tocopheryl acetate, water.

  • protect this product from excessive heat and direct sun.

Call toll free 1-844-875-4176

USA Distributor

ARION PERFUME & BEAUTY INC,

SAN ANTONIO, TX - 78212

U.S.A.

Packaging

Packaging

EAD

Avobenzone,Homosalate,Octisalate,Octocrylene LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63049-101
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 1.44 g
HOMOSALATE Homosalate 2.40 g
OCTISALATE OCTISALATE 6.00 g
OCTOCRYLENE Octocrylene 1.20 g

Inactive Ingredients

Ingredient Name Strength
.ALPHA.-AMYLCINNAMALDEHYDE
ASCORBYL PALMITATE
BENZYL ALCOHOL
BUTYLPARABEN
C12-15 ALKYL BENZOATE
CARBOMER 934
POLYOXYL 20 CETOSTEARYL ETHER
CETOSTEARYL ALCOHOL
ETHYLPARABEN
GLYCERYL MONOSTEARATE
GLYCERYL STEARATE SE
isobutylparaben
LINALOOL, (+/-)-
METHYLPARABEN
PEG-100 STEARATE
PHENOXYETHANOL
propylene glycol
PROPYLPARABEN
SODIUM HYDROXIDE
SODIUM CETOSTEARYL SULFATE
EDETATE SODIUM
ALPHA-TOCOPHEROL ACETATE
water

Product Characteristics

Color
white

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63049-101-23 120 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-03-18


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