WALGREENS SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) LOTION [WALGREEN CO.]

WALGREENS SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) LOTION [WALGREEN CO.]
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NDC 0363-4016-19, 0363-4016-22, 0363-4016-29
Set ID 8b30caa7-1f3b-4e45-8e16-5e33580bb35b
Category HUMAN OTC DRUG LABEL
Packager WALGREEN CO.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Avobenzone 3.0 %

    Homosalate 10.0%

    Octisalate 5.0%

    Octocrylene 10.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions) decrease 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.

    • May stain some fabrics.

  • 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 increase 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 am - 2 pm
    • Wear long sleeves shirts, pants, hats and sunglasses
    • children under 6 month of age: Ask a doctor

  • Inactive Ingredients

    Water, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Diethylhexyl Syringylidenemalonate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Stearate, PEG-100 Stearate, Caprylic/ Capric Triglyceride, Disodium EDTA, Oleth-3, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, Benzyl Alcohol, Chlorphenesin, Fragrance.


  • Other information

    Protect this product from excessive heat and direct sun. 

  • Questions or comments

    1-800-WALGREENS (1-800-925-4733) 

  • Principal Display Panel

    NDC 0363-4016-29

    VALUE SIZE

    Well at

    Walgreens

    LOTION

    Sunscreen

    Broad Spectrum SPF 30

    • Water resistant (80 minutes)
    • UVA/UVB protection

    16 FL OZ (473 mL)

    Label29




    NDC 0363-4016-22

    Well at Walgreens

    WALGREENS PHARMACIST RECOMMENDED

    SUNSCREEN

    Lotion

    Broad Spectrum SPF 30

    • Water resistant (80 minutes)
    • UVA/UVB protection

    30

    10 FL OZ (296 mL)

    Label22




    NDC 0363-4016-19

    Well at Walgreens

    WALGREENS PHARMACIST RECOMMENDED

    SUNSCREEN

    Lotion

    Broad Spectrum SPF 30

    • Water resistant (80 minutes)
    • UVA/UVB protection

    30

    3 FL OZ (88 mL)

    Label19

  • INGREDIENTS AND APPEARANCE
    WALGREENS SUNSCREEN  BROAD SPECTRUM SPF 30
    avobenzone homosalate octisalate octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SORBITOL (UNII: 506T60A25R)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OLETH-3 (UNII: BQZ26235UC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-4016-29465 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/07/2013
    2NDC:0363-4016-22296 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/09/2016
    3NDC:0363-4016-1988 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/07/2013
    Labeler - WALGREEN CO. (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Playtex Manufacturing Co.963501502manufacture(0363-4016)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schick Manufacturing Inc.193866378relabel(0363-4016)

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