Label: CARDINAL HEALTH LEADER GENERAL PROTECTION SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated November 4, 2022

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  • Active ingredients

    Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, 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.

    • 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 a doctor if

    • rash occurs.

  • 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 the skin to apply

    • Do not spray directly into face. Spray into hands then apply to face

    • Do not apply in windy conditions

    • Use in a 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 value 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-sleeved shirts, pants, hats, and sunglasses

  • Other information

    • protect the product in this container from excessive heat and direct sun

    • may stain or damage some fabrics, materials or surfaces

  • Inactive ingredients

    SD alcohol 40-B, butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol, fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

  • Label

    Cardinal Health Leader General Protection Sunscreen SPF 30 Clear Continious Spray

    5.5 oz (156 g)

    NDC 70000-0073-1

    CL14043

  • INGREDIENTS AND APPEARANCE
    CARDINAL HEALTH LEADER GENERAL PROTECTION SUNSCREEN SPF 30 
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0073
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    ALCOHOL (UNII: 3K9958V90M)  
    STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0073-1156 g in 1 CAN; Type 0: Not a Combination Product12/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/09/2020
    Labeler - CARDINAL HEALTH, INC. (063997360)
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