Label: LEADER SPORT SUNSCREEN SPF 50 MOISTURIZING- avobenzone, homosalate, octisalate, octocrylene lotion

  • 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 December 4, 2019

If you are a consumer or patient please visit this version.

  • Active ingredients

    Avobenzone 3.0%

    Homosalate 10.0%

    Octisalate 4.5%

    Octocrylene 8.0%

  • 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 • on damaged or broken skin.

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

  • 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

    • apply liberally 15 minutes before sun exposure

    • 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

    Water, Polyester-7, Neopentyl Glycol Diheptanoate, Glycerin, Aluminum Starch Octenylsuccinate, Styrene/Acrylates Copolymer, Silica, Phenoxyethanol, Isododecane, Arachidyl Alcohol, Beeswax, Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Behenyl Alcohol, Tocopherol (Vitamin E), Arachidyl Glucoside, Glyceryl Stearate, PEG-100 Stearate, Potassium Hydroxide, Disodium EDTA, Sodium Ascorbyl Phosphate, Fragrance.

  • Questions or comments?

    Call toll free 1-800-527-7731

  • PRINCIPAL DISPLAY PANEL

    Leader Sport Sunscreen SPF 50 Moisturizing Lotion

    8 FL OZ (237mL)

    NDC 70000-0257-1

    Label

  • INGREDIENTS AND APPEARANCE
    LEADER  SPORT SUNSCREEN SPF 50 MOISTURIZING
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0257
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYESTER-7 (UNII: 0841698D2F)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISODODECANE (UNII: A8289P68Y2)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    WATER (UNII: 059QF0KO0R)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0257-1237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/22/2019
    Labeler - CARDINAL HEALTH, INC. (097537435)
    Registrant - FRUIT OF THE EARTH, INC. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(70000-0257)