Label: PLUMSCREEN SPF 31- zinc oxide cream

  • NDC Code(s): 80476-101-02, 80476-101-10, 80476-101-60
  • Packager: LP FOUNDERS, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 4, 2024

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  • ACTIVE INGREDIENTS

    ZINC OXIDE (NON-NANO) 4.7%

  • PURPOSE

    SUNSCREEN

  • USES

    • HELPS PREVENT SUNBURN
    • IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), THIS PRODUCT REDUCES THE RISK OF SKIN 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 ATTENTION OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
  • DIRECTIONS

    • APPLY LIBERALLY AND EVENLY 15 MINUTES BEFORE EXPOSURE TO ALL SKIN EXPOSED TO THE SUN. REAPPLY AT LEAST EVERY 2 HOURS.
    • USE A WATERPROOF SUNSCREEN IF SWIMMING OR SWEATING
    • CONSULT YOUR DOCTOR BEFORE APPLYING ON CHILDREN UNDER 6 MONTHS OF AGE.
  • OTHER INFORMATION

    • TO BEST MAINTAIN FORMULA, STORE AWAY FROM EXCESSIVE HEAT AND DIRECT SUN.
  • INACTIVE INGREDIENTS

    WATER (AQUA), COCO-CAPRYLATE/CAPRATE, PRUNUS DOMESTICA SEED OIL, PRUNUS DOMESTICA EXTRACT, HYDROLYZED PRUNUS DOMESTICA FRUIT EXTRACT, GLYCERIN, CETEARYL ALCOHOL, CETEARYL OLIVATE, SORBITAN OLIVATE, PROPANEDIOL, ZONARIA TOURNEFORTII EXTRACT, SODIUM STEAROYL GLUTAMATE, SILICA, XANTHAN GUM, TETRASODIUM GLUTAMATE DIACETATE, POLYHYDROXYSTEARIC ACID, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCERYL ETHER

  • QUESTIONS?

    VISIT WWW.LEPRUNIER.COM

  • PRINCIPAL DISPLAY PANEL

    0-UC_Plumscreen_SPF31

  • INGREDIENTS AND APPEARANCE
    PLUMSCREEN  SPF 31
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80476-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PLUM JUICE (UNII: KLB93D0YFI)  
    WATER (UNII: 059QF0KO0R)  
    PLUM SEED OIL (UNII: 67EIU8N086)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCERYL ETHER (UNII: MI97BW74XZ)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80476-101-101 in 1 BOX06/21/2022
    110 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:80476-101-601 in 1 BOX06/21/2022
    260 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:80476-101-022 mL in 1 PACKET; Type 0: Not a Combination Product01/04/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/21/2022
    Labeler - LP FOUNDERS, INC. (063025213)
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