Label: EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUM- avobenzone, homosalate, octisalate, octocrylene. lotion

  • NDC Code(s): 49035-797-11, 49035-797-44, 49035-797-49
  • Packager: Wal-Mart Stores Inc
  • 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 16, 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, styrene/acrylates copolymer, aluminum starch octenylsuccinate, 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.

  • PRINCIPAL DISPLAY PANEL

    Equate Sunscreen SPF 50 SPORT Broad Spectrum Lotion Label

  • INGREDIENTS AND APPEARANCE
    EQUATE SUNSCREEN SPF 50 SPORT  BROAD SPECTRUM
    avobenzone, homosalate, octisalate, octocrylene. lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-797
    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
    WATER (UNII: 059QF0KO0R)  
    POLYESTER-7 (UNII: 0841698D2F)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISODODECANE (UNII: A8289P68Y2)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-797-11237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/02/2019
    2NDC:49035-797-44946 mL in 1 BOTTLE; Type 0: Not a Combination Product05/02/2019
    3NDC:49035-797-4944.4 mL in 1 BOTTLE; Type 0: Not a Combination Product05/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/30/2019
    Labeler - Wal-Mart Stores Inc (051957769)
    Registrant - FRUIT OF THE EARTH, INC. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth, Inc.080086802manufacture(49035-797)