Label: MEIJER - avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

  • NDC Code(s): 41250-035-22
  • Packager: Meijer Distribution Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/13

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

  • ACTIVE INGREDIENT

    Active ingredients


    Avobenzone     3.0%

    Homosalate     15.0%

    Octisalate        5.0%

    Octocrylene      4.5%

    Oxybenzone     6.0%



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  • Purpose

    Sunscreen


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  • 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
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  • 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 increases 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 a.m.-2 p.m.
    •    wear long sleeve shirts, pants, hats and sunglasses
    •    children under 6 months of age: Ask a doctor.
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  • Inactive ingredients

    Water, Styrene/Acrylates Copolymer, Butyloctyl Salicylate, Glyceryl Stearate, Silica, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Methicone, Sodium Polyacrylate, Benzyl Alcohol, Beeswax, Ethylhexyl Stearate, Dimethicone, Cetyl Dimethicone, Xanthan Gum, Trimethylsiloxysilicate, Trideceth-6, Disodium EDTA, Dipotassium Glycyrrhizate, BHT, Chlorphenesin, Fragrance..

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  • Principal Display Panel

    meijer

    Sheer

    Sunscreen lotion

    light, clean feel

    dermatologist tested

    85

    Broad Spectrum 85

    Water Resistant

    (80 Minutes)

    3 FL. OZ.

    (88 mL)


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  • Other information

    • protect the product from excessive heat and direct sun.
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  • INGREDIENTS AND APPEARANCE
    MEIJER 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41250-035
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g  in 100 g
    HOMOSALATE (HOMOSALATE) HOMOSALATE 15 g  in 100 g
    OCTISALATE (OCTISALATE) OCTISALATE 5 g  in 100 g
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 4.5 g  in 100 g
    OXYBENZONE (OXYBENZONE) OXYBENZONE 6 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    GLYCERYL MONOSTEARATE  
    SILICON DIOXIDE  
    PEG-100 STEARATE  
    CAPRYLYL TRISILOXANE  
    BENZYL ALCOHOL  
    YELLOW WAX  
    ETHYLHEXYL STEARATE  
    DIMETHICONE  
    XANTHAN GUM  
    TRIDECETH-6  
    EDETATE DISODIUM  
    GLYCYRRHIZINATE DIPOTASSIUM  
    BUTYLATED HYDROXYTOLUENE  
    CHLORPHENESIN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41250-035-22 85 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 07/12/2013
    Labeler - Meijer Distribution Inc (006959555)
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