Label: GLOW SCREEN SPF 40- avobenzone, octisalate, octocylene cream

  • NDC Code(s): 75936-216-01, 75936-216-02, 75936-216-03, 75936-216-04, view more
    75936-216-05, 75936-216-06, 75936-216-07
  • 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 July 10, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients  Purpose
    Avobenzone      3% Sunscreen
    Octisalate         5% Sunscreen
    Octocylene        10% Sunscreen

  • PURPOSE

    Uses
    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

    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

    Directions

    •  Apply generously and evenly 15 minutes before sun exposure
    •   Reapply at least every 2 hours

     Use a water resistant sunscreen if swimming or sweating
     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 10a.m. – 2p.m.

    •  Wear long-sleeved shirts, pants, hats, and sunglasses
    •  Children under 6 months: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients
    Water, Propanediol, Butyloctyl Salicylate, Glycerin, C12-15 Alkyl Benzoate, Polymethylsilsesquioxane, Niacinamide, Glyceryl Stearate Citrate, Bismuth Oxychloride, Mica, Titanium Dioxide, Lauryl Lactate, Isododecane, Isodecyl Neopentanoate, Glyceryl Stearate, Diisopropyl Sebacate, Cetyl Phosphate, Caprylic/Capric Triglyceride, Coco-Caprylate, Ethylhexyl Hydroxystearate, Butylene Glycol, Arginine, Hydroxyacetophenone, Caprylyl Glycol, 1,2-Hexanediol, Iron Oxides, Sodium Hyaluronate, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Trisodium Ethylenediamine Disuccinate, Phospholipids, Limonium Gerberi Extract, Leuconostoc/Radish Root Ferment Filtrate, Theobroma Cacao (Cocoa) Seed Extract, Pantothenic Acid, Tocopherol, Helianthus Annuus (sunflower) Seed Oil, Ferulic Acid

  • PRINCIPAL DISPLAY PANEL

    Supergoop!

    Glowscreen

    SPF 40 Sunrise

    Broad Spectrum Sunscreen

    SPF 40 PA+++

    1.7 fl. oz./ 50 ml.

    Glowscreen SPF 40 cart

    Glowscreen SPF 40 OL

  • INGREDIENTS AND APPEARANCE
    GLOW SCREEN SPF 40 
    avobenzone, octisalate, octocylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-216
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 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
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    ISODODECANE (UNII: A8289P68Y2)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ARGININE (UNII: 94ZLA3W45F)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    LIMONIUM GERBERI WHOLE (UNII: 2J5K7YCF9F)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    COCOA (UNII: D9108TZ9KG)  
    PANTOTHENIC ACID (UNII: 19F5HK2737)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    FERULIC ACID (UNII: AVM951ZWST)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-216-011.5 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    2NDC:75936-216-025 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    3NDC:75936-216-0310 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    4NDC:75936-216-0415 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    5NDC:75936-216-0550 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    6NDC:75936-216-0620 mL in 1 TUBE; Type 0: Not a Combination Product05/18/2021
    7NDC:75936-216-0773.9 mL in 1 TUBE; Type 0: Not a Combination Product01/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2020
    Labeler - Supergoop, LLC (117061743)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway Company, Inc052400223manufacture(75936-216)
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