Label: ACADEMY SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone 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 July 20, 2016

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  • Active Ingredients

    AVOBENZONE 1.5%, HOMOSALATE 15.0%, OCTISALATE 5.0%, OCTOCRYLENE 1.2%, 

    OXYBENZONE 6.0%

  • 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

  • Warning

    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 liberally15 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 .am. to 2 p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses
    • children under 6 months of age: Ask a doctor
  • Inactive Ingredients


    Water, Hydrogenated Dimer Dilinoleyl/Dimethylcarbonate Copolymer, Stearyl Alcohol, Glycerin, Caprylyl Glycol, Cetyl Alcohol, Triethanolamine, Carbomer, Glyceryl Stearate, Behenyl Alcohol, Xanthan Gum, Sodium Lauroyl Sarcosinate, Disodium EDTA, Dipropylene Glycol, BHT, Disodium Ethylene Dicocamide PEG-15 Disulfate, Glyceryl Stearate Citrate, Cetearyl Alcohol, Sodium Lauroyl Lactylate, Retinyl Palmitate, Tocopheryl Acetate, Lecithin, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Methyldibromo Glutaronitrile, Methylchloroisothiazolinone, Methylisothiazolinone.




  • Other information

    • protect this product from excessive heat and direct sun
  • Principle Display Label


    NDC 59054-880-10

    Academy

    SPORTS+OUTDOOR

    SUNSCREEN LOTION

    BROAD SPECTRUM

    SPF 50

    40

    Water Resistant

    (80 Minutes)

    Hypoallergenic

    UVA/UVB protection

    16 FL. OZ.

    (473 mL)

    Label



  • INGREDIENTS AND APPEARANCE
    ACADEMY SPF 50  
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59054-880
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.2 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLDIBROMO GLUTARONITRILE (UNII: YX089CPS05)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59054-880-10473 g in 1 BOTTLE; Type 0: Not a Combination Product07/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/20/2016
    Labeler - ACADEMY, LTD (065092538)
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