Label: GLOW OIL BROAD SPECTRUM SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene oil

  • NDC Code(s): 75936-152-01, 75936-152-02
  • 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

    Homosalate 10% Sunscreen

    Octisalate 5% Sunscreen

    Octocrylene 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

    Do not use on damaged or broken skin
    When using this product keep out of eyes. Rinse with water to remove
    For external use only

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply generously and evenly 15 minutes before sun exposure
    • Reapply
    • at least every 2 hours.
    • after 80 minutes 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 your time in the sun, especially from 10
    a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses

    • Children under 6 months of age: ask a doctor.
  • INACTIVE INGREDIENT

    Caprylic/Capric Triglyceride, Alcohol, Octyldodecanol, C12-15 Alkyl Benzoate, Polyester-8, Polyamide-3, Lauryl Lactate, Isodecyl Neopentanoate, Diisopropyl Sebacate, Diethylhexylsyringylidenemalonate, Tocopherol, Glycine Soja (Soybean)Oil, Vitis Vinifera (grape) Seed Oil, Raphanus Sativus (Radish) Seed Oil, Limnanthes Alba(Meadowfoam) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (coconut) Oil, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, Pentaerythrityl Tetra-di-t-butyl hydroxyhydrocinnamate. Alaria Esculanta Extract, t-Butyl Alcohol, Cucumis Sativus(cucumber) Fruit Extract, Denatonium Benzoate, Citric Acid

  • PRINCIPAL DISPLAY PANEL

    Supergoop!

    Glow Oil SPF 50

    Broad Spectrum Sunscreen SPF 50

    Water Resistant (80 minutes) 1 fl. oz./ 30 ml

    Glow Oil SPF 50 bottle

    top label

    inside top

    bottom label

  • INGREDIENTS AND APPEARANCE
    GLOW OIL BROAD SPECTRUM SUNSCREEN SPF 50 
    avobenzone, homosalate, octisalate, octocrylene oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-152
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    CUCUMBER (UNII: YY7C30VXJT)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    ALARIA ESCULENTA (UNII: EJ9JK8J58D)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-152-01148 mL in 1 BOTTLE; Type 0: Not a Combination Product11/12/2019
    2NDC:75936-152-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product11/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/12/2019
    Labeler - Supergoop, LLC (117061743)
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