CARDINAL HEALTH LEADER SPF 30 GENERAL PROTECTION SUNSCREEN CLEAR CONTINUOUS- avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray

Cardinal Health Leader by

Drug Labeling and Warnings

Cardinal Health Leader by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Inc., Fruit Of The Earth, Inc., Fruit Of The Earth Research Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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

FLAMMABLE:

do not use near heat, flame or while smoking

avoid long term storage above 104°F (40°C)

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. keep away from face to avoid breathing it. do not puncture or incinerate. Contents under pressure. do not store at temperatures above 120° F.

STOP USE

​Stop use and ask doctor if​

• rash occurs.

KEEP OUT OF REACH OF CHILDREN

​Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center right away.

Directions

spray liberally and spread evenly by hand 15 minutes before sun exposure
hold can 4-6 inches away from skin to apply
do not spray directly into face. Spray into hand and then apply to face.
do not apply in windy conditions
use in well-ventilated area
reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
children under 6 months of age: ask a doctor
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

Other Information

protect this product from excessive heat and direct sun

may stain or damage some fabrics, materials or surfaces

Inactive ingredients

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

Questions or comments?

Call toll free 1-800-527-7731

PRINCIPAL DISPLAY PANEL

Cardinal Health Leader SPF 30 General Protection Sunscreen Clear Continuous Spray

NDC: 70000-0327-1

NET WT 5.5 OZ (156 g)

INGREDIENTS AND APPEARANCE

CARDINAL HEALTH LEADER  SPF 30 GENERAL PROTECTION SUNSCREEN CLEAR CONTINUOUS
avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0327
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
TOCOPHEROL (UNII: R0ZB2556P8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0327-1	156 g in 1 CAN; Type 0: Not a Combination Product	02/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/20/2018

Labeler - Cardinal Health, Inc. (097537435)

Registrant - Fruit Of The Earth, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(70000-0327)