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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 23, 2021

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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.

    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:

    • Limit time in the sun, especially from 10 a.m. - 2 p.m. 
    • Wear long-sleeved shirts, pants, hats and sunglasses.
  • 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 not finalpart35209/01/2021
    Labeler - Pure Haven, LLC (080591039)
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