Label: BRIGHT-EYED 100% MINERAL EYE CREAM BROAD SPECTRUM SUNSCREEN SPF 40- zinc oxide cream

  • NDC Code(s): 75936-149-01, 75936-149-02, 75936-149-03, 75936-149-04
  • 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

    Zinc Oxide 14.4 % 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

  • INACTIVE INGREDIENT

    Inactive Ingredients Water, Caprylic/Capric Triglyceride, Glycerin, Propanediol, Butyloctyl Salicylate, Glyceryl Stearate Citrate, Lauroyl Lysine, Cetyl Esters, Inulin Lauryl CarbamatePolyhydroxystearic Acid, Cetearyl Alcohol, Potassium Cetyl phosophate, Griffonia Simplicifolia Seed Extract, Titanium Dioxide, Olive Oil Polyglyceryl-6 Esters, Mica, Triethoxycaprylylsilane, Microcrystalline cellulose, Glyceryl Glucoside, Hydroxyacetophenone, Polyurethane-79, Diethylhexyl Syringylidenemalonate, Sodium Stearoyl Lactylate, 1,2-Hexanediol, Caprylyl Glycol, Sodium Citrate, Trisodium Ethylenediamine Disuccinate, Camellia Sinensis Leaf Extract, Lactobacillus Ferment Lysate, Punica Granatum Extract, Sodium Citrate, Sodium Stearoyl Glutamate, Xanthan Gum, Cellulose Gum, Iron Oxides, Hedychium Coronarium Root Extract, Lactobacillus Ferment, Caffeine, Leuconostoc/Radish Root Ferment Filtrate, Tin Oxide.

  • PRINCIPAL DISPLAY PANEL

    Supergoop!

    Bright-eyed

    100% Mineral Eye Cream

    SPF 40

    Broad Spectrum

    Sunscreen SPF 40 PA +++

    0.5 fl. oz. / 15 mL

    Bright eye mineral carton

  • INGREDIENTS AND APPEARANCE
    BRIGHT-EYED 100% MINERAL EYE CREAM BROAD SPECTRUM SUNSCREEN SPF 40 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-149
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LACTOBACILLUS REUTERI (UNII: 9913I24QEE)  
    CAFFEINE (UNII: 3G6A5W338E)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    GRIFFONIA SIMPLICIFOLIA SEED (UNII: LUS5142TMY)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MICA (UNII: V8A1AW0880)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-149-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    2NDC:75936-149-025 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    3NDC:75936-149-031.5 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    4NDC:75936-149-045 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2020
    Labeler - Supergoop, LLC (117061743)
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