Label: PURE HAVEN FACE SUNSCREEN SPF-30- zinc oxide lotion

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

Drug Label Information

Updated November 11, 2023

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  • Drug Facts

  • Active Ingredients

    Zinc Oxide (14%)

    Purpose

    sunscreen

  • Uses:

    • Helps prevent sunburn.
    • Higher SPF gives more sunburn protection.
    • 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.
  • 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.

    Stop use and ask a doctor if

    • rash or irritation develops and lasts.

    Keep out of reach of children.

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

  • Directions:

    • Apply liberally 15 minutes before sun exposure. 
    • Children under 6 months of age: ask a doctor.
    • Reapply at least every 2 hours.
    • Reapply as needed or after towel drying, swimming, or sweating.
    • Use a water-resistant sunscreen if swimming or sweating.
    • Limit time in the sun, especially from 10 a.m. - 2 p.m. 
    • Wear long-sleeved shirts, pants, hats and sunglasses.

    SUN PROTECTION MEASURES.

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:

  • Inactive Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Citric Acid, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hydrolyzed Jojoba Esters, Lecithin, Polyhydroxystearic Acid, Tocopherol (Vitamin E),Tridecyl Salicylate, Xanthan Gum.

  • Other Information:

    • Protect the product in this container from excessive heat and direct sun.
  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    PURE HAVEN FACE SUNSCREEN SPF-30 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71355-219
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION140 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71355-219-0030 mL in 1 JAR; Type 0: Not a Combination Product09/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/01/2021
    Labeler - Pure Haven, LLC (080591039)
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