Label: ELTAMD UV PURE SPF47- zinc oxide and titanium dioxide sunscreen cream

  • NDC Code(s): 72043-2582-2, 72043-2582-4
  • Packager: CP Skin Health Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 27, 2024

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

  • 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 physician if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Active Ingredients

    Zinc Oxide 10.0% Sunscreen

    Titanium Dioxide 5.5% Sunscreen

  • Uses

    helps prevents sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • Uses

    helps prevents sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • Directions

    Apply liberally 15 minutes before sun exposure Reapply after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures. Spending time int he sun increases your risk of skin cancer and early skin aging. To decrease this risk, egularly use a sunscreen with a broad-spectrum SPF 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-sleeve shirts, pants, hats and sunglasses Children under 6 months: Ask a physician.

  • Inactive Ingredients

    Purified Water, Cyclopentasiloxane, Dimethicone, Octyldodecyl neopentanoate, laury PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Ascorbyl Palmitate, Tocopherol, Sodium Chloride, Triethoxycaprylylsilane, Alumina, Hydrogen Dimethicone, Potassium Sorbate, Citric Acid

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Labeling

    UV Pure Unit Carton artwork_Page_1

  • INGREDIENTS AND APPEARANCE
    ELTAMD UV PURE SPF47 
    zinc oxide and titanium dioxide sunscreen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2582
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION100 g  in 1000 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE55 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72043-2582-4114 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
    2NDC:72043-2582-22 g in 1 PACKET; Type 0: Not a Combination Product07/06/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/10/2018
    Labeler - CP Skin Health Group, Inc. (611921669)
    Registrant - Swiss-American CDMO, LLC (080170933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(72043-2582)