CARDINAL HEALTH LEADER SPF 70 GENERAL PROTECTION SUNSCREEN CLEAR CONTINUOUS- avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray 
Cardinal Health, Inc.

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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Cardinal Health Leader SPF 70 General Protection Sunscreen Clear Continuous Spray

Active ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 6.0%

Purpose

Sunscreen

Uses

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

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 and ask doctor if

​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. (73.2% v/v), acrylates/octylacrylamide copolymer, glycerin, diethylhexyl syringylidenemalonate, fragrance, caprylic/capric triglyceride

Questions or comments?

Call toll free 1-800-527-7731

Cardinal Health Leader SPF 70 General Protection Sunscreen Clear Continuous Spray

NDC: 70000-0326-1

NET WT 5.5 OZ (156 g)

Label

CARDINAL HEALTH LEADER  SPF 70 GENERAL PROTECTION SUNSCREEN CLEAR CONTINUOUS
avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0326
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0326-1156 g in 1 CAN; Type 0: Not a Combination Product02/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/20/2018
Labeler - Cardinal Health, Inc. (097537435)
Registrant - Fruit Of The Earth, Inc. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(70000-0326)

Revised: 2/2018
Document Id: 65b0fc20-7257-5319-e053-2a91aa0a3f5c
Set id: 65b0fc20-7267-5319-e053-2a91aa0a3f5c
Version: 1
Effective Time: 20180220
 
Cardinal Health, Inc.