Label: ELTAMD UV PHYSICAL SPF41- zinc oxide and titanium dioxide sunscrreen lotion

  • NDC Code(s): 72043-2578-2, 72043-2578-3
  • Packager: CP Skin Health Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 2023

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 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 9.0%   Sunscreen
    Titanium Dioxide 7.0%   Sunscreen

  • Uses

    Helps prevent 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 prevent 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 40 minutes of swimming or sweating immediately after towel drying at lest 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 sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: limit time int he 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

    Alumina, Butylene Glycol, Citric Acid, Iodopropynyl Butylcarbamate, Iron Oxide, Isopropyl Palmitate, Lecithin, Linoleic Acid, Hydrogen Dimethicone, Octyl Stearate, Octyldodecyl Neopentanoate, Oleth-3 Phosphate, Perfluorononyl Dimethicone, Phenoxyethanol, Polyacrylate 13, Polyisobutene, Polysorbate 20, Purified Water, Quercitin, Sodium Hydroxide, Thioctic Acid, Triethoxycaprylylsilane

  • KEEP OUT OF REACH OF CHILDREN 

    KEEP OUT OF REACH OF CHILDREN 

  • Labeling

    UV Physical UC_Page_1

  • INGREDIENTS AND APPEARANCE
    ELTAMD UV PHYSICAL SPF41 
    zinc oxide and titanium dioxide sunscrreen lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2578
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION90 g  in 1000 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE70 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    OCTYL STEARATE (UNII: 772Y4UFC8B)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    THIOCTIC ACID (UNII: 73Y7P0K73Y)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    QUERCETIN (UNII: 9IKM0I5T1E)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72043-2578-385 g in 1 TUBE; Type 0: Not a Combination Product01/10/2018
    2NDC:72043-2578-22 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(72043-2578)