Label: WALGREENS SPF 50 HYDRATING- avobenzone, homosalate, octisalate, octocrylene lotion

  • NDC Code(s): 0363-0136-09, 0363-0136-14
  • Packager: WALGREEN COMPANY
  • 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 January 27, 2023

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

  • Active ingredients

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

  • 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 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

    water, tridecyl salicylate, propylene glycol, styrene/acrylates copolymer, polyamide-8, neopentyl glycol diheptanoate, oleth-3, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, tocopherol, disodium EDTA, chlorphenesin, benzyl alcohol, fragrance

  • Label

    W04280A1

    W04393A1

  • INGREDIENTS AND APPEARANCE
    WALGREENS SPF 50 HYDRATING 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0136
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    OLETH-3 (UNII: BQZ26235UC)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0136-14237 mL in 1 BOTTLE; Type 0: Not a Combination Product02/09/2021
    2NDC:0363-0136-0989 mL in 1 BOTTLE; Type 0: Not a Combination Product02/09/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/09/2021
    Labeler - WALGREEN COMPANY (008965063)