Label: GLOW SCREEN BODY BROAD SPECTRUM SUNSCREEN SPF 40- avobenzone, homosalate, octisalate, octocrylene cream

  • NDC Code(s): 75936-350-01, 75936-350-02, 75936-350-03
  • Packager: Supergoop, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 19, 2022

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  • ACTIVE INGREDIENT

    Avobenzone 3%..............Sunscreen

    Homosalate 7%.............Sunscreen

    Octisalate 5%..................Sunscreen

    Octocrylene 10%............Sunscreen

  • PURPOSE

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • 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.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs.

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    • apply generously and evenly 15 minutes before sun exposure
    • reapply:
    • after 40 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 decreases this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection meausres including: Limit time in the sun, especially from 10 a.m.-2 p.m. Wear long-sleeved shirts, pants, hats, and sunglassess. Children under 6 months: Ask a doctor.
  • INACTIVE INGREDIENT

    Aletris Farinosa Root Extract, Bisabolol, Butyloctyl Salicylate,Calcium Sodium Borosilicate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryly Glycol, Cetearyl Alcohol, Coco-Caprylate/Caprate, Coco-Glucoside, Coconut Alkanes, Erythritol, Ethyl Ferulate, Ethylhexyl Methoxycrylene, Glycerin, Glyceryl Stearate, Hydrogenated Polycyclopentadiene, Methyl Dlhydroabietate, Mica, Polyester-8, Propanedlol, Sodium Gluconate, Sodium Polyacrylate Starch, Sodium Stearoyl Glutamate, Titanium Dioxide, Tocopherol, Water, Xanthan Gum

  • OTHER SAFETY INFORMATION

    Protect the product in this container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL

    Supergoop!

    Glow Screen Body

    SPF 40

    Broad Spectrum Sunscreen

    SPF 40 PA+++

    Water & Sweat Resistant (40 minutes)

    3.4 fl. oz. / 100 ml.

    Tube

    Carton

  • INGREDIENTS AND APPEARANCE
    GLOW SCREEN BODY BROAD SPECTRUM SUNSCREEN SPF 40 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-350
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    WATER (UNII: 059QF0KO0R)  
    ERYTHRITOL (UNII: RA96B954X6)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALETRIS FARINOSA ROOT (UNII: O021JGR97X)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MICA (UNII: V8A1AW0880)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-350-01100 mL in 1 TUBE; Type 0: Not a Combination Product01/20/2021
    2NDC:75936-350-0210 mL in 1 TUBE; Type 0: Not a Combination Product01/20/2021
    3NDC:75936-350-0315 mL in 1 TUBE; Type 0: Not a Combination Product01/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/20/2021
    Labeler - Supergoop, LLC (117061743)
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