Label: MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide stick

  • 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 January 21, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • ACTIVE INGREDIENT:

    ZINC OXIDE 20%

  • PURPOSE:

    SUNSCREEN

  • USES:

    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 IMMEDIATELY.
  • DIRECTIONS:

    • PLEASE ADHERE TO YOUR PHYSICIAN'S PROTOCOL FOR THIS PRODUCT*
    • WOULD MUST BE FULLY CLOSED AND NO LONGER SCABBED
    • GENTLY GLIDE OVER SCAR 15 MINUTES PRIOR TO SUN EXPOSURE
    • REAPPLY: AFTER 80 MINUTES OF SWIMMING OR SWEATING, IMMEDIATELY AFTER TOWEL DRYING, EVERY TWO HOURS
    • CHILDREN UNDER 6 MONTHS: CONSULT YOUR PHYSICIAN
    • FOR OPTIMAL RESULTS, USE IN CONJUNCTION WITH RCP SCAR MANAGEMENT*

    *FOR MORE INFORMATION ON PROTOCOLS VISIT WWW.RCPCARE.COM/RECOVERYRESOURCES

  • OTHER INFORMATION:

    PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

  • INACTIVE INGREDIENTS:

    ALOE BARBADENSIS LEAF JUICE (ALOE VERA)*, BUTYROSPERMUM PARKII (SHEA) BUTTER*, CERA ALBA (BEESWAX)*, COCOS NUCIFERA (COCONUT) OIL*, COPERNICIA CERIFERA (CARNAUBA) WAX*, EUPHORBIA CERIFERA CERA (CANDELILLA) WAX, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*, RICINUS COMMUNIS (CASTOR) SEED OIL*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL

    *CERTIFIED ORGANIC INGREDIENTS

  • PRINCIPAL DISPLAY PANEL

    01b UC_Mineral Sunscreen_front

    01b UC_Mineral Sunscreen_back

  • INGREDIENTS AND APPEARANCE
    MINERAL SUNSCREEN   BROAD SPECTRUM SPF 30
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72525-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72525-003-0114 g in 1 TUBE; Type 0: Not a Combination Product11/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/20/2018
    Labeler - RECOVERY CARE PRODUCTS, LLC (081338122)
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

More Info on this Drug

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