LEADER GENERAL PROTECTION SUNSCREEN SPF 30 - avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients

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

Purpose

Sunscreen

Uses

• 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

Warnings

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.

Keep out of reach of children.

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

Directions

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

Inactive Ingredients

water, sorbitol, aluminum 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

Other infomation

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

Questions or Comments?

Call toll free 1-800-527-7731

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LEADER GENERAL PROTECTION SUNSCREEN SPF 30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-729
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (AVOBENZONE)	AVOBENZONE	30.6 mg in 1 mL
HOMOSALATE (HOMOSALATE)	HOMOSALATE	132.6 mg in 1 mL
OCTISALATE (OCTISALATE)	OCTISALATE	51 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE)	OCTOCRYLENE	71.4 mg in 1 mL
OXYBENZONE (OXYBENZONE)	OXYBENZONE	40.8 mg in 1 mL

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

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:37205-729-34	237 mL in 1 CAN	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/15/2012

Labeler - Cardinal Health (097537435)

Registrant - Fruit of the Earth (008193513)

Establishment
Name	Address	ID/FEI	Operations
Fruit of the Earth		008193513	manufacture

Revised: 01/2013 Cardinal Health