Label: PUBLIX  SPF 30- avobenzone, homosalate, octisalate and octocrylene lotion 

  • Label RSS
  • NDC Code(s): 56062-713-16, 56062-713-22
  • Packager: Publix Super Markets 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 3.0%

    Homosalate 10.0%

    Octisalate    5.0%

    Octocrylene 10.0%



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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 sun.
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  • Warnings

    For external use only

    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 the 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 literally 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

    Other information

    protect this product from excessive heat and direct sun


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  • Inactive ingredients

    water, Ethylhexyl Plamitate, 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 Acorbyl Phosphate, Benzyl Alcohol, Chlorphenesin, Fragrance.


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  • Principal Display Panel

    publix

    SUNSCREEN

    LOTION

    BROAD SPECTRUM

    SPF 30

    MOISTURIZING

    WATER RESISTlNT

    (80 MINTUES)

    UVA/UVB Protection

    8 FL OZ (236 mL)

    ZPU007A0.jpg

    publix

    SUNSCREEN

    LOTION

    BROAD SPECTRUM

    SPF 30

    MOISTURIZING

    WATER RESISTlNT

    (80 MINTUES)

    UVA/UVB Protection

    3 FL OZ (88 mL)

    ZPU015A0.jpg
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  • INGREDIENTS AND APPEARANCE
    PUBLIX   SPF 30
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:56062-713
    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 10 g  in 100 g
    OCTISALATE (OCTISALATE) OCTISALATE 5 g  in 100 g
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ETHYLHEXYL PALMITATE  
    SORBITOL  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE  
    TROLAMINE  
    GLYCERYL MONOSTEARATE  
    EDETATE DISODIUM  
    PEG-100 STEARATE  
    TRICAPRYLIN  
    OLETH-3  
    TOCOPHEROL  
    SODIUM ASCORBYL PHOSPHATE  
    ALOE VERA LEAF  
    BENZYL ALCOHOL  
    CHLORPHENESIN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:56062-713-16 226 g in 1 BOTTLE, PLASTIC
    2 NDC:56062-713-22 85 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 07/16/2013
    Labeler - Publix Super Markets Inc (006922009)
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