Label: WALGREENS SPF 30 HYDRATING- avobenzone, homosalate, octisalate, octocrylene lotion

  • NDC Code(s): 0363-0146-09, 0363-0146-14
  • 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 February 6, 2023

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  • Active ingredients

    Avobenzone 2.7%, Homosalate 8.0%, Octisalate 5.0%, Octocrylene 3.5%

  • 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 on this container from excessive heat and direct sun
    • may stain or damage some fabrics, materials or surfaces

  • Inactive ingredients

    Water, Butyloctyl Salicylate, Dimethicone, Potassium Cetyl Phosphate, Benzyl Alcohol, Caprylyl Glycol, Silica, Cetyl Dimethicone, Beeswax, PPG-12/SMDI Copolymer, Ethylhexylglycerin, Dimethicone/PEG-10/15 Crosspolymer, Trilsiloxane, Ethylhexyl Stearate,Acrylates/C12-22 Alklmethacrylate Copolymer, Propylene Glycol, Behenyl Alcohol, Sodium Polyacrylate, Trideceth-6, Styrene/Acrylates Copolymer, Disodium EDTA, Glyceryl Stearate, PEG-100 Stearate, Xanthan Gum, Chlorphenesin, Fragrance.

  • Label

    W018452A2

    W00849A2

  • INGREDIENTS AND APPEARANCE
    WALGREENS SPF 30 HYDRATING 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0146
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE35 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE27 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0146-14237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/17/2020
    2NDC:0363-0146-0989 mL in 1 BOTTLE; Type 0: Not a Combination Product09/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/17/2020
    Labeler - WALGREEN COMPANY (008965063)
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