Label: ETHICAL ZINC NATURAL CLEAR ZINC SUNSCREEN SPF-50- 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 September 25, 2023

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  • ACTIVE INGREDIENTS

    ZINC OXIDE 22.00%

  • PURPOSE

    SUNSCREEN

  • USE

    • HELPS PREVENT SUNBURN.
    • IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS) DECREASES THE RISK OF 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 OCCURS.

  • 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.

  • DIRECTIONS

    • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.

    REAPPLY:

    • AFTER 80 MINUTES OF SWIMMING OR SWEATING
    • IMMEDIATELY AFTER TOWEL DRYING
    • AT LEAST EVERY 2 HOURS
    • CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.
  • INACTIVE INGREDIENTS

    MEDIUM CHAIN TRIGLYCERIDES, WHITE BEESWAX, COCO-CAPRYLATE, CASTOR OIL, COCONUT OIL, POLYGLYCERYL-3 POLYRICINOLEATE, ISOSTEARIC ACID, D-ALPHA-TOCOPHERYL ACETATE, FRENCH VANILLA FRAGRANCE

  • OTHER INFORMATION

    • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
  • PRINCIPAL DISPLAY PANEL

    USA_40x134mmx100g_FINAL_OUTLINE

  • INGREDIENTS AND APPEARANCE
    ETHICAL ZINC NATURAL CLEAR ZINC SUNSCREEN   SPF-50
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72962-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION22 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72962-101-11100 mL in 1 TUBE; Type 0: Not a Combination Product03/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/29/2017
    Labeler - ETHICAL ZINC PTY LTD (745184258)
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