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Leader

Cardinal Health
Fruit of the Earth

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  • Clinical Pharmacology
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Leader General Protection SPF 30 Continuous Spray Sunscreen 6 fl oz - Drug Facts Label

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Oxybenzone 4.0%, Octocrylene 2.0%

Sunscreen

• 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 near heat, flame or while smoking
  • avoid long term storage above 104 deg F (40 degC)

on damaged or broken skin

keep out of eyes. Rinse with water to remove. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 deg F.

if rash occurs.

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

Directions

Apply liberally 15 minutes before sun exposure

Hold can 4-6 inches away form body, spray evenly to ensure complete coverage

Do not spray into face. Spray into hand and apply to face.

Use in well ventilated, but not windy areas

Reapply:

After 80 minutes of swimming or sweating

Immdiately after towel drying

At least every 2 hours

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease theis 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 am - 2 pm

wear long sleeve shirts, pants, hats, and sunglasses

Alcohol denat. (76.2% V/V), acrylates/octylacrylamide copolymer, stearoxytrimethylsilane, glycerin,diethylhexyl syringylidenemalonate, tocopherol (vitamin E), fragrance, retinyl palmitate (vitamin A palmitate), caprylic/capric triglyceride

Questions or Comments?

Call toll free 1-800-200-6313

IMAGE OF LABEL

Label3.jpgIMAGE OF LABEL

Leader

Homosalate, Octisalate, Oxybenzone, Octocrylene, Avobenzone AEROSOL, SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-731
Route of Administration Topical DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HOMOSALATE Homosalate 87 mg
OCTISALATE OCTISALATE 43.5 mg
OCTOCRYLENE Octocrylene 17.4 mg
OXYBENZONE OXYBENZONE 34.8 mg
AVOBENZONE AVOBENZONE 26.1 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
stearoxytrimethylsilane
GLYCERIN
Diethylhexyl Syringylidenemalonate
Tocopherol
VITAMIN A PALMITATE
MEDIUM-CHAIN TRIGLYCERIDES

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-731-30 177 in 1 CAN

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-01-15


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