Label: MEADOW AND BARK SPF 45 MINERAL SPORT SUNSCREEN- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 3, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Zinc Oxide 19%

  • PURPOSE

    Sunscreen.

  • INDICATIONS & USAGE

    Helps prevent sunburn.

  • WARNINGS

    For external use only.

    Do no use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

    When using this product keep out of eyes. Rinse with water to remove.

  • KEEP OUT OF REACH OF CHILDREN

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at lease every 2 hours.

    For children under 6 months of age: ask a doctor.

  • INACTIVE INGREDIENT

    Aloe Barbadensis (Aloe) Leaf Juice*, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Curcuma Longa (Turmeric) Root Extract*, Deionized Water, Diisostearoyl Polyglycery-3 Dimer Dilinoleate, Ethyl Lauroyl Arginate HCl, Extracts of Alaria Esculenta (Wakame Seaweed), Camelia Sinensis (Green Tea) Leaf*, Ocimum Tenuiflorum (Tulsi) Leaf*, Olea Europa (Olive) Leaf* in Cocos Nucifera (Coconut) Oil, Iron Oxides (CI 77492, CI 77491, CI 77499), Isoamyl Laurate, Jojoba Esters, Mica, Mixed Tocopherols, Olive Squalane Oil, Polyglyceryl-3 Oleate, Polyhydroxystearic Acid, Olive Squalane Oil, Polyglceryl-3 Oleate, Polyhydroxystearic Acid, Propanediol, Silica, Sodium Chloride, Sodium Stearoyl Glutamate, Tetrasodium Glutamate Diacetate, Vegetarian Glycerin, Xanthan Gum, *ORGANIC INGREDIENTS

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    MEADOW AND BARK SPF 45 MINERAL SPORT SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84199-045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYL LAUROYL ARGINATE HYDROCHLORIDE (UNII: XPD6ZY79TB)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALARIA ESCULENTA (UNII: EJ9JK8J58D)  
    SQUALANE (UNII: GW89575KF9)  
    POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)  
    MICA (UNII: V8A1AW0880)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    HOLY BASIL LEAF (UNII: SCJ765569P)  
    WATER (UNII: 059QF0KO0R)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TURMERIC (UNII: 856YO1Z64F)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84199-045-0275 mL in 1 TUBE; Type 0: Not a Combination Product03/29/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/29/2024
    Labeler - Meadow and Bark (104407707)
    Establishment
    NameAddressID/FEIBusiness Operations
    Stream2Sea, LLC052920828manufacture(84199-045)