Label: WALGREENS 100 SHEER BROAD SPECTRUM SPF 100- avobenzone, homosalate, octisalate, octocrylene lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 April 24, 2023

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  • Active ingredients

    Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

  • 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 product is 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

    • 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: Ask a doctor
  • 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

    Water, Tridecyl salicylate , Butyloctyl Salicylate , Cyclopentasiloxane, Isodecyl Neopentanoate, Silica, Diisopropyl Sebacate, Lauryl Lactate, Glyceryl Stearate, PEG-100 Stearate, Acrylates/Dimethicone Copolymer, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Cetearyl Glucoside, Cetearyl Alcohol, Caprylyl Glycol, cetearyl Olivate, Sorbitan Olivate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Fragrance, Tocopherol, Dipotassium Glycyrrhizate, Hexylene Glycol, Triethanolamine, Disodium EDTA.

  • Label

    W01468A

    W1470A1

    W01470K1

  • INGREDIENTS AND APPEARANCE
    WALGREENS 100 SHEER BROAD SPECTRUM SPF 100 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0228
    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) HOMOSALATE150 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0228-66100 mL in 1 TUBE; Type 0: Not a Combination Product05/06/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02005/06/2022
    Labeler - WALGREEN COMPANY (008965063)
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