Leader Sport SPF 30 Continuous Spray Sunscreen

Leader Sport SPF 30 Continuous Spray Sunscreen

Drug Labeling and Warnings

Drug Details

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LEADER SPORT SPF 30- homosalate, octisalate, oxybenzone, octocrylene, avobenzone aerosol, spray 
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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Leader Sport SPF 30 Continuous Spray Sunscreen

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Oxybenzone 4.0%, Octocrylene 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

FLAMMABLE

  • do not use near heat, flame or while smoking
  • avoid long term storage above 104°F (40°C)

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120° F.

Stop use and ask a 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

Hold can 4-6 inches away from body, spray evenly to ensure complete coverage

Do not spray into face. Spray into hand and apply to face.

Use in well ventilated, but not windy areas

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 am - 2 pm

wear long sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

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

Questions or Comments?

Call toll free 1-800-200-6313

Leader Sport SPF 30 Continuous Spray Sunscreen

Product NDC: 37205-726 Label

LEADER  SPORT SPF 30
homosalate, octisalate, oxybenzone, octocrylene, avobenzone aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37205-726
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
TOCOPHEROL (UNII: R0ZB2556P8)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37205-726-30177 mL in 1 CAN; Type 0: Not a Combination Product01/15/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/15/2012
Labeler - Cardinal Health (097537435)
Registrant - Fruit Of The Earth, Inc. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(37205-726)

Revised: 11/2019
 
Cardinal Health


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