Label: KELSEN - UNDER THE SUN BROAD SPECTRUM SPF 50 MINERAL SUNSCREEN- zinc oxide paste

  • NDC Code(s): 82626-102-11, 82626-102-12
  • Packager: KELSEN PRODUCTS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 31, 2024

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

View All Sections
  • ACTIVE INGREDIENT

    ZINC OXIDE 30%

  • PURPOSE

    SUNSCREEN

  • USE

    HELPS PREVENT SUNBURN

  • 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 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.
    • USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
    • REAPPLY AT LEAST EVERY 2 HOURS.
    • SUN PROTECTION MEASURES. SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS 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 A.M. - 2 P.M.
    • WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
  • OTHER INFORMATION

    • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
  • INACTIVE INGREDIENTS

    Caprylic/Capric Triglyceride, Beeswax, Montmorillonite, Lanolin, Theobroma Cacao (Cocoa) Seed Butter, Theobroma Cacao (Cocoa) Powder, Tocopherol, Triethoxycaprylylsilane, Iron Oxides.

  • PRINCIPAL DISPLAY PANEL

    PDP

    Base

  • INGREDIENTS AND APPEARANCE
    KELSEN - UNDER THE SUN BROAD SPECTRUM  SPF 50 MINERAL SUNSCREEN
    zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82626-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MONTMORILLONITE (UNII: A585MN1H2L)  
    LANOLIN (UNII: 7EV65EAW6H)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    COCOA (UNII: D9108TZ9KG)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82626-102-1150 g in 1 JAR; Type 0: Not a Combination Product12/05/2022
    2NDC:82626-102-1215 g in 1 JAR; Type 0: Not a Combination Product12/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/05/2022
    Labeler - KELSEN PRODUCTS INC (085656269)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!