Label: MEIJER SPF 15 - avobenzone, homosalate, octisalate and octocrylene lotion 

  • Label RSS
  • NDC Code(s): 41250-042-57
  • 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 ingredients

    Avobenzone   2.0%

    Homosalate   10.0%

    Octisalate       5.0%

    Octocrylene    5.0%

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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), decrease 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.

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  • When using this product

    Keep out of eyes. Rinse with water to remove.

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  • Stop use and ask a doctor

    if rash occurs

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  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics.

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  • 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, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Triethanolamine, Disodium EDTA, Carbomer, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Chlorphenesin, Fragrance.

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  • Other Information

    •  protect this product from excessive heat and direct sun
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  • Principal Display Panel

    meijer

    Sunscreen lotion

    moisturizing

    dermatologist tested

    15

    Broad Spectrum SPF 15

    Water Resistant

    (80 Minutes)

    10 FL. OZ. (295 mL)


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  • INGREDIENTS AND APPEARANCE
    MEIJER SPF 15 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41250-042
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (AVOBENZONE) AVOBENZONE 2 g  in 100 g
    HOMOSALATE (HOMOSALATE) HOMOSALATE 10 g  in 100 g
    OCTISALATE (OCTISALATE) OCTISALATE 5 g  in 100 g
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ETHYLHEXYL PALMITATE  
    SORBITOL  
    BENZYL ALCOHOL  
    DIMETHICONE  
    GLYCERYL MONOSTEARATE  
    PEG-100 STEARATE  
    TROLAMINE  
    EDETATE DISODIUM  
    TOCOPHEROL  
    ALOE VERA LEAF  
    CHLORPHENESIN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41250-042-57 286 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 07/17/2013
    Labeler - Meijer Distribution Inc (006959555)
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