Label: SUNSCREEN SPF-50 TINTED- 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 May 24, 2019

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  • ACTIVE INGREDIENTS

    ZINC OXIDE 22.5%

  • 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 PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    FOR USE ON CHILDREN LESS THAN 6 MONTHS OF AGE, CONSULT A HEALTH CARE PRACTITIONER. APPLY LIBERALLY/GENEROUSLY (AND EVENLY) 15 MINUTES BEFORE SUN EXPOSURE. REAPPL AFTER 80 MINUTES OF SWIMMING OR SWEATING OR IMMEDIATELY AFTER TOWEL DRYING. 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 SUN SCREEN WITH A BROAD SPECTRUM OF SPF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:

    • LIMIT TIME IN THE SUN, FROM 10 A.M. - 2 P.M.
    • WEAR LONG-SLEEVE SHIRTS, PANTS, HATS, AND SUNGLASSES
    • CHILDREN UNDER 6 MONTHS: ASK A DOCTOR
  • INACTIVE INGREDIENTS

    * TYROSPERMUM PARKII (SHEA) BUTTER, * BEESWAX (CIRE D'ABIELLE), * COCOS NUCIFERA (COCONUT) OIL, SILICA, * COPERNICIA PRUNIFERA (CARNAUBA) WAX,* HELIANTHUS ANNUUS (SUNFLOWER) OIL, IRON OXIDE, MICA, SILICA, * SIMMONDSIA CHINENSIS (JOJOBA) OIL, * THEOBROMA CACAO (COCOA) BUTTER, VITAMIN E.

    * CERTIFIED ORGANIC

  • OTHER INFORMATION

    • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN
  • QUESTIONS OR COMMENTS?

    CALL TOLL FREE 1 888 952 4250

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Face Stick SPF-50 Tinted_US_front

    01b LBL_Face Stick SPF-50 Tinted_US_back

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN  SPF-50 TINTED
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71585-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION22.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    JOJOBA OIL (UNII: 724GKU717M)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71585-106-1115 g in 1 TUBE; Type 0: Not a Combination Product08/29/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/29/2017
    Labeler - SALT AND STONE (080683697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Filltech USA, LLC926433855manufacture(71585-106)
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