Label: ACADEMY SPORT SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 June 28, 2013

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  • ACTIVE INGREDIENT

    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), decreases 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 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.
  • 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.

  • Principal Display Panel

    Academy

    SPORTS+OUTDOORS

    SUNSCREEN LOTION

    BROAD SPECTRUM SPF 30

    30

    Water Resistant

    (80 Minutes)

    Hypoallergenic

    UVA/UVB Protection

    8 FL. OZ.

    (236 mL)



    untitled.jpg

  • Other information

    • protect the product from excessive heat and direct sun.
  • INGREDIENTS AND APPEARANCE
    ACADEMY SPORT SPF 30 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59054-370
    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)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OLETH-3 (UNII: BQZ26235UC)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:59054-370-16226 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/28/2013
    Labeler - ACADEMY, LTD (065092538)
    Establishment
    NameAddressID/FEIBusiness Operations
    PLAYTEX MANUFACTURING INC963501502manufacture(59054-370)
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