Label: HYDRATING SPF 30- avobenzone 3% homosalate 15% octisalate 5% octocrylene 8% spray

  • 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 April 27, 2018

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  • ACTIVE INGREDIENT

    Active ingredients                                                              Purpose
    Avobenzone 3%.................................................................Sunscreen
    Homosalate 15%...............................................................Sunscreen
    Octisalate 5%....................................................................Sunscreen
    Octocrylene 8%.................................................................Sunscreen

  • PURPOSE

  • INDICATIONS & USAGE

    Uses • helps prevent sunburn • higher SPF gives more sunburn
    protection • retains SPF after 80 minutes of activity in the water
    or sweating

  • WARNINGS

    Warnings
    Flammable: Do not use near heat, flame, or while smoking.
    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 or irritation develops and last

    Avoid spraying in eyes. Contents under pressure. Do not puncture or
    incinerate. Do not store at temperature above 120°F

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical
    help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions • Apply liberally 15 minutes before sun exposure and
    as needed. • Children under 6 months of age: ask a doctor. • 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
    value 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-sleeved shirts,
    pants, hats, and sunglasses. • Hold container 4 to 6 inches from the skin
    to apply. • Do not spray directly into face. Spray on hands then apply to
    face. • Do not apply in windy conditions. • Use in a well-ventilated area.
    • For sunscreen use: • apply to all skin exposed to the sun. • Reapply as
    needed or after towel drying, swimming, or sweating

  • OTHER SAFETY INFORMATION

    Other information • protect the product in this container
    from excessive heat and direct sun • may stain fabrics.

  • INACTIVE INGREDIENT

    Inactive ingredients
    Acrylates/Octylacrylamide
    Copolymer, Alcohol Denat.,
    Aloe Barbadensis Leaf
    Extract, Caprylic/Capric
    Triglyceride, Diethylhexyl
    Syringylidenemalonate, Fragrance,
    Glycerin, Retinyl Palmitate,
    Stearoxytrimethylsilane,
    Tocopherol.

  • Questions?1-800-925-4733

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HYDRATING SPF 30 
    avobenzone 3% homosalate 15% octisalate 5% octocrylene 8% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1123
    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) Homosalate15 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 g
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)  
    Glycerin (UNII: PDC6A3C0OX)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Stearoxytrimethylsilane (UNII: 9862TW94B2)  
    Tocopherol (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1123-05156 g in 1 CAN; Type 0: Not a Combination Product11/16/2016
    2NDC:0363-1123-06283 g in 1 CAN; Type 0: Not a Combination Product11/16/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/16/2016
    Labeler - Walgreens (008965063)
    Registrant - Product Quiest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quiest Mfg927768135manufacture(0363-1123) , label(0363-1123)