Label: HYDRATING SPF 50- avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 10.00% 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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients                                                           Purpose
    Avobenzone 3%.............................................................Sunscreen
    Homosalate 15%...........................................................Sunscreen
    Octisalate 5%................................................................Sunscreen
    Octocrylene 10%...........................................................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 • provides moderate protection against sunburn

  • 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.

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HYDRATING SPF 50 
    avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 10.00% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1120
    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) Octocrylene10 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:0363-1120-05156 g in 1 CAN; Type 0: Not a Combination Product11/16/2016
    2NDC:0363-1120-06283 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 Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(0363-1120) , label(0363-1120)