SUNSCREEN SPF-50 (ZINC OXIDE) STICK [SALT AND STONE]

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SUNSCREEN SPF-50 (ZINC OXIDE) STICK [SALT AND STONE]
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NDC 71585-104-11
Set ID 6567d2d9-cc58-4918-9da9-acc113cafc0f
Category HUMAN OTC DRUG LABEL
Packager SALT AND STONE
Generic Name
Product Class
Product Number
Application Number PART352
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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_S&S_Face Stick SPF-50_US

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN  SPF-50
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71585-104
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71585-104-1115 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(71585-104)
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