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Leader

Cardinal Health
Fruit of the Earth

Leader Baby Sunscreen Moisturizing Lotion SPF 50 - Drug Facts Label


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Avobenzone 3.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 7.0% Oxybenzone 4.0%

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 on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if rash occurs.

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

  • 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

water, sorbitol, alminum, starch octenylsuccinate, VP/eicosene copolymer, stearic acid, triethanolamine, sorbitan isostearate, benzyl alcohol, dimethicone, tocopherol (vitamin E), polyglyceryl-3 distearate, fragrance, methylparaben, carbomer, propylparaben, disodium EDTA

  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

Call toll free 1-800-527-7731

Image of Label

Label10.jpgLeader

Leader

Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-721
Route of Administration Topical DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 30.9 mg
HOMOSALATE Homosalate 133.9 mg
OCTISALATE OCTISALATE 57.5 mg
OCTOCRYLENE Octocrylene 72.1 mg
OXYBENZONE OXYBENZONE 41.2 mg

Inactive Ingredients

Ingredient Name Strength
water
sorbitol
ALUMINUM STARCH OCTENYLSUCCINATE
COPOVIDONE K25-31
STEARIC ACID
TROLAMINE
Sorbitan Isostearate
BENZYL ALCOHOL
DIMETHICONE
Tocopherol
POLYGLYCERYL-3 DISTEARATE
METHYLPARABEN
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
PROPYLPARABEN
EDETATE DISODIUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-721-34 237 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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