Label: SUNSCREEN SPORT SPF 50 EXCHANGE SELECT- avobenzone 3.0% homosalate 10.0% octocrylene 6.0% 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 June 4, 2018

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

  • ACTIVE INGREDIENT

    Active ingredients                                   Purpose
    Avobenzone 3%.....................................Sunscreen
    Homosalate 10%....................................Sunscreen
    Octocrylene 6%.....................................Sunscreen

  • PURPOSE

  • INDICATIONS & USAGE

    Uses • helps prevent sunburn • higher SPF gives more sunburn protection • retains SPF after 80 minutes of activity in the water

  • WARNINGS

    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

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions • Apply liberally 15 minutes
    before sun exposure and as needed. • 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 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. • Children under
    6 months of age: ask a doctor.

  • OTHER SAFETY INFORMATION

    Other information

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

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aluminum
    Starch Octenylsuccinate, Benzyl Alcohol,
    Butyloctyl Salicylate, Carbomer, Dimethicone,
    Disodium EDTA, Methylparaben,
    Polyglyceryl-3 Distearate, Propylparaben,
    Sorbitan Isostearate, Sorbitol, Stearic Acid,
    Tocopherol, Triethanolamine, VP/Eicosene
    Copolymer, Water.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN SPORT SPF 50  EXCHANGE SELECT
    avobenzone 3.0% homosalate 10.0% octocrylene 6.0% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-778
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 mL
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate10 g  in 100 mL
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Polyglyceryl-3 Distearate (UNII: ZI1LK470XV)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Sorbitan Isostearate (UNII: 01S2G2C1E4)  
    Sorbitol (UNII: 506T60A25R)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Tocopherol (UNII: R0ZB2556P8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55301-778-06237 mL in 1 CONTAINER; Type 0: Not a Combination Product12/05/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/05/2017
    Labeler - Your Military Exchange (001695568)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(55301-778) , label(55301-778)