Label: EXCHANGE SELECT SUNSCREEN SPF 30- avobenzone homosalate 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 November 16, 2012

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  • Active Ingredients

    Avobenzone 2.0 %

    Homosalate 10.0%

    Octisalate 5.0%

    Octocrylene 2.0%

    Oxybenzone 2.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • retains SPF after 80 minutes of activity in the water
  • 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 or irritation develops and lasts.

    keep out of reach of children

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

  • Directions

    • apply generously before sun exposure and as needed
    • children under 6 months of age:ask a doctor
    • reapply frequently and after towel drying, swimming or perspiring.
  • Other Information

    • May stain some fabrics
    • Sun Alert: Limiting sun exposure, wearing, protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • Inactive Ingredients

    Water, Sorbitan Isostearate, Sorbitol, Polyglyceryl-3 Distearate, Triethanolamine, Stearic Acid, VP/Eicosene Copolymer, Benzyl Alcohol, Dimethicone, Barium Sulfate, Carbomer, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Disodium EDTA, Cocos Nucifera (Coconut) Oil, Mineral Oil, Octadecene/MA Copolymer, Aloe Barbadensis Leaf Extract, Methylparaben, Propylparaben, Fragrance.
  • Principal Display Panel

    exchange
    select
    X
    SUNSCREEN
    lotion
    SPF
    30
    Photostable
    Broad Spectrum
    UVA/UVB Protection
    Very Water Resistant
    8 FL. OZ. (237mL)
    ZES004A0f.jpg
    ZES004A0b.jpg
  • INGREDIENTS AND APPEARANCE
    EXCHANGE SELECT SUNSCREEN  SPF 30
    avobenzone homosalate octocrylene oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 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) OCTOCRYLENE2 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55301-009-56226 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/16/2012
    Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)
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