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

Leader by

Drug Labeling and Warnings

Leader by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 2.0%, Homosalate 10.5%, Octisalate 5.0%, Octocrylene 2.0%, Oxybenzone 2.0%

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

Do not use on damaged or broken skin.

WHEN USING

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

ASK DOCTOR

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, sorbitan isostearate, sorbitol, triethanolamine, polyglyceryl-3 distearate, stearic acid, octadecene/MA copolymer, barium sulfate, benzyl alcohol, VP/eicosene copolymer, dimethicone, carbomer, methylparaben, aloe barbadensis leaf extract, simmondsia chinensis (jojoba) seed oil, tocopherol (vitamin E), cocos nucifera (coconut) oil, mineral oil, propylparaben, fragrance, 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

PRINCIPAL DISPLAY PANEL

Leader General Protection Sunscreen Moisturizing Lotion SPF 30

Product NDC: 37205-728

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-728
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	105 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MALEIC ACID (UNII: 91XW058U2C)
WATER (UNII: 059QF0KO0R)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SORBITOL (UNII: 506T60A25R)
TROLAMINE (UNII: 9O3K93S3TK)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
STEARIC ACID (UNII: 4ELV7Z65AP)
OCTADECENE (UNII: H5ZUQ6V4AK)
BARIUM SULFATE (UNII: 25BB7EKE2E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
DIMETHICONE (UNII: 92RU3N3Y1O)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-728-34	237 mL in 1 CAN; Type 0: Not a Combination Product	01/15/2012

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, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(37205-728)