Label: SURFACE SUN DRY TOUCH SPF 50 SUNSCREEN- avobenzone, humosalate, octisalate, octocrylene 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 December 27, 2022

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  • ACTIVE INGREDIENT

    Active ingredient

    Avobenzone 3.0%

    Homosalate 15%

    Octisalate 5%

    Octocrylene 10%

  • WHEN USING

    When using this product:

    • keep out of eyes. Rinse with water to remove.

    • Keep away from face to avoid breathing it.

    • Do not puncture or incinerate, Contents under pressure

    • Do not store at temperature above 120⁰F

    Stop use and ask a doctor if rash occurs.

  • PURPOSE

    Avobenzone 3.0% ……………………………………………………………………………… Sunscreen

    Homosalate 15.0% ……………………………………………………………………………. Sunscreen

    Octisalate 5.0% …………………………………………………………………………………. Sunscreen

    Octocrylene 10.0% ……………………………………………………………………………. Sunscreen

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INACTIVE INGREDIENT

    Behenyl Alcohol

    BHT

    Butyloctyl Salicylate

    Caprylyl Methicone Dimethicone

    Dimethyl Capramide

    Disodium EDTA

    Ethylhexyl Stearate

    Ethylhexylglycerin

    Fragrance

    Glyceryl Stearate Hydrated Silica

    PEG-100 Stearate

    Phenoxyethanol

    Polyester-8

    Sodium Polyacrylate

    Styrene/Acrylates Copolymer

    Trideceth-6

    Trimethylsiloxysilicate

    VP/Hexadecene Copolymer

    Water

    Xanthan Gum

  • WHEN USING

    • keep out of eyes. Rinse with water to remove.

    • Keep away from face to avoid breathing it.

    • Do not puncture or incinerate, Contents under pressure

    • Do not store at temperature above 120⁰F

    Stop use and ask a doctor if rash occurs.

  • PRINCIPAL DISPLAY PANEL

    Surface Sun Dry Touch SPF 30 Sunscreen

  • INGREDIENTS AND APPEARANCE
    SURFACE SUN DRY TOUCH SPF 50 SUNSCREEN 
    avobenzone, humosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72344-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BEHENYL BEHENATE (UNII: K8NU647RJ0)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72344-107-06170 g in 1 CAN; Type 0: Not a Combination Product12/27/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/27/2022
    Labeler - Surface Products Corp (010777036)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions081030372manufacture(72344-107)
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