Label: EXCHANGE SELECT DARK TANNING SUNSCREEN SPF 4- 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 October 25, 2013

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  • Active ingredients

    Octocrylene 1.0%

    Oxybenzone 0.5 %


  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.


    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 the reach of children.

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

  • 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
    • children under 6 months of age: Ask a doctor
  • Other information

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

    Water, Petrolatum, Diisopropyl Adipate, Propylene Glycol, Polyglyceryl-3 Methylglucose Distearate, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Benzyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea) Butter, Disodium EDTA, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice Powder, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Methylparaben, Propylparaben, Quaternium-15, Fragrance.


  • Principal Display Panel

    exchange

    select

    X

    Sunscreen lotion

    4

    SPF 4

    Moisturing

    Water Resistant

    (80 Minutes)

    8 FL. OZ. (236 mL)


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  • Questions or comments?

    Call 1-396-673-2024


  • INGREDIENTS AND APPEARANCE
    EXCHANGE SELECT DARK TANNING SUNSCREEN  SPF 4
    octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    QUATERNIUM-15 (UNII: E40U03LEM0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55301-005-16226 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/25/2013
    Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)
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