Label: MINERAL SHEER SCREEN BROAD SPECTRUM SUNSCREEN SPF 30- zinc oxide lotion

  • NDC Code(s): 75936-305-01, 75936-305-02, 75936-305-03, 75936-305-04, view more
    75936-305-05
  • 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

    Active Ingredient Purpose

    Zinc Oxide 17.5% Sunscreen

  • PURPOSE

    Sunscreen

    Helps prevent sunburn.

    If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg 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 kee out of eyes. Rinse with water to remove.

  • DOSAGE & ADMINISTRATION

    • 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 10 a.m. - 2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglassess
    • Children under 6 months: Ask a doctor.

  • INACTIVE INGREDIENT

    Water, Isododecane, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Propanedlol, Glycerin, Squalane, Trioctyldodecyl Citrate, Polyglycerln-3, Polyglyceryl-3 Lactate/Laurate, Polysilicone-11, Cetearyl Alcohol, Glyceryl Stearate, Sodium Stearoyl Glutamate, Butylene Glycol, Xanthan Gum, Polyacrylate Crosspolymer-6, lsostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Caprylhydroxamic Acid, Citric Acid, Aloe Barbadensis Leaf Juice, Lespedeza Capitata Leaf/Stem Extract, Maltodextrin, Sodium Hyaluronate

  • STORAGE AND HANDLING

    Protect the product In this container from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL

    Mineral Sheer Screen

    SPF 30

    100% Mineral

    Broad Spectrum Sunscreen

    SPF 30 PA+++

    1.5 fl. oz./45 ml

    CartonTube

  • INGREDIENTS AND APPEARANCE
    MINERAL SHEER SCREEN BROAD SPECTRUM SUNSCREEN SPF 30 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-305
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISODODECANE (UNII: A8289P68Y2)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SQUALANE (UNII: GW89575KF9)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-305-0145 mL in 1 TUBE; Type 0: Not a Combination Product01/12/2021
    2NDC:75936-305-0215 mL in 1 TUBE; Type 0: Not a Combination Product01/12/2021
    3NDC:75936-305-0310 mL in 1 TUBE; Type 0: Not a Combination Product01/12/2021
    4NDC:75936-305-045 mL in 1 TUBE; Type 0: Not a Combination Product01/12/2021
    5NDC:75936-305-0520 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/12/2021
    Labeler - Supergoop LLC (117061743)
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