Label: EXCHANGE SELECT KIDS SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray 

  • Label RSS
  • NDC Code(s): 55301-007-16
  • Packager: ARMY AND AIR FORCE EXCHANGE SERVICE
  • 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 10/13

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

  • Active ingredients

    Avobenzone 3.0 %

    Homosalate 13.0%

    Octisalate 5.0%

    Octocrylene 2.0%

    Oxybenzone 4.0%

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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 swallowed, get medical help or contact a Poison Control Center right away.

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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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  • Other information

    • protect this product from excessive heat and direct sun
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  • Inactive ingredients

    Water, Styrene/Acrylates Copolymer, Sorbitol, Benzyl Alcohol, Triethanolamine, Dimethicone, Polyglyceryl-3 Distearate, Sorbitan Isostearate, Stearic Acid, VP/Eicosene Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.


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  • Principal Display Panel

    exchange

    select

    X

    KIDS

    SPRAY

    SUNSCREEN

    50

    BROAD SPECTRUM SPF 50

    UVA/UVB Protection

    Water Resistant

    (80 Minutes)

    8 FL.OZ. (236 mL)


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  • INGREDIENTS AND APPEARANCE
    EXCHANGE SELECT KIDS SUNSCREEN  SPF 50
    avobenzone spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55301-007
    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 13 g  in 100 g
    OCTISALATE (OCTISALATE) OCTISALATE 5 g  in 100 g
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 2 g  in 100 g
    OXYBENZONE (OXYBENZONE) OXYBENZONE 4 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SORBITOL  
    STEARIC ACID  
    TROLAMINE  
    DIMETHICONE  
    BENZYL ALCOHOL  
    SORBITAN ISOSTEARATE  
    METHYLPARABEN  
    PROPYLPARABEN  
    TOCOPHEROL  
    EDETATE DISODIUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55301-007-16 226 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 10/15/2013
    Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)
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