Label: WAX SPF 50- zinc oxide, allantoin ointment

  • Category: HUMAN OTC DRUG LABEL

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 June 2, 2022

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  • DRUG FACTS

  • Active Ingredients

    Zinc Oxide 20.00%

    Allantoin 2%

    Purpose

    Sunscreen

    Skin Protectant

  • Uses:

    Temporarily protects and helps relieve chapped or chafed skin. Helps prevent and protect from the drying effects of wind and cold weather. Helps prevent sunburn. Higher SPF gives more sunburn protection.

  • Warnings:

    For external use only.

    Do not use

    • on damaged or broken skin.
    • Do not use deep or puncture wounds animal bites serious burns.

    Stop use and ask a doctor 

    • If rash occurs conditions worsens symptoms last more than 7 days or clear up again within a few days.

    When using this product

    • Keep out of eyes.
    • Rinse with water to remove.

    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 and as needed. Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every two hours.
    • Children under 6 months of age: Ask a doctor.

    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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sunglasses.

  • Inactive Ingredients:

    Simmondsia Chinensis (Jojoba) Seed Oil, Jojoba Esters, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Argania Spinosa Kernel Oil (Argan Oil), Tocopherol, Bisabolol, Calcium Silicate, Phytosteryl/Behenyl/Octyldodecyl Lauroyl Glutamate, Oryza Sativa (Rice) Bran Oil, Oryza Sativa (Rice) Bran Wax, Rhus Succedanea Fruit Wax, Helianthus Annuus (Sunflower) Seed Oil

  • Other Information:

    Protect this product from excessive heat and direct sun.

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    WAX SPF 50 
    zinc oxide, allantoin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82177-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION200 mg  in 1 mL
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    RICE BRAN (UNII: R60QEP13IC)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82177-002-0060 mL in 1 JAR; Type 0: Not a Combination Product07/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/01/2022
    Labeler - Biomin LLC. (105075828)
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