Label: MINERAL MATTESCREEN SPF 40- titanium dioxide, zinc oxide cream

  • NDC Code(s): 75936-281-01, 75936-281-02, 75936-281-03, 75936-281-04, view more
    75936-281-05
  • Packager: Supergoop, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 14, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Titanium Dioxide 1.3% Sunscreen

    Zinc Oxide 17.4% 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.
  • 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 sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sunprotection measures including: • limit your time in the sun, especially from 10a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses
    • Children under 6 months of age: ask a doctor.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Dimethicone, Dimethicone Copolymer, Caprylic/Capric Triglyceride, Methyl Dihydroabietate, Polyhydroxystearic Acid, C9-12 Alkane, Glycerin, Iron Oxides (CI 77492), Ethylhexylglycerin, Water (Aqua), Coco-Caprylate/Caprate, Silica, Stearic Acid, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Hedychium Coronarium Root Extract, Lactobacillus/Arundinaria Gigantea Leaf Ferment Filtrate, Leuconostoc/Radish Root Ferment Filtrate, Titanium Dioxide (CI 77891)

  • PRINCIPAL DISPLAY PANEL

    Mineral Mattescreen SPF 40

    100% Mineral Broad Spectrum Sunscreen SPF 40 PA +++

    1.5 fl. oz./45 ml

    Carton

    Tube

    20 ml packaging

    Carton

    Tube

    15 ml packaging

    Tube

    Back Label

    10 ml packaging

    Tube

    1.5 ml packette

    packette

  • INGREDIENTS AND APPEARANCE
    MINERAL MATTESCREEN SPF 40 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-281
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.3 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-281-015 mL in 1 TUBE; Type 0: Not a Combination Product05/18/2021
    2NDC:75936-281-0210 mL in 1 TUBE; Type 0: Not a Combination Product05/18/2021
    3NDC:75936-281-0345 mL in 1 CARTON; Type 0: Not a Combination Product05/18/2021
    4NDC:75936-281-0420 mL in 1 TUBE; Type 0: Not a Combination Product09/02/2021
    5NDC:75936-281-051.5 mL in 1 PACKET; Type 0: Not a Combination Product05/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/18/2021
    Labeler - Supergoop, LLC (117061743)
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