Label: ELTAMD UV DAILY SPF40- zinc oxide and octinoxate sunscreen lotion

  • NDC Code(s): 72043-2289-1, 72043-2289-2
  • Packager: CP Skin Health Group, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 9, 2023

If you are a healthcare professional or from the pharmaceutical industry 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 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

    Octinoxate 7.5% 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 to face, neck and backs of hands 15 minutes before sun exposure Use a water-resistant sunscreen if swimming or sweating 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 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, Petrolatum, Isopropyl Palmitate, Cetearyl Glucoside, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Sodium Hyaluronate, Tocopheryl Acetate, Polyether-1, Citric Acid, Oleth-3 Phosphate, Phenoxyethanol, Butylene Glycol, Iodopropynyl Butylcarbamate, Triethoxycaprylylsilane

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Labeling

    RM8513 Box UC UV Daily 1.7oz

  • INGREDIENTS AND APPEARANCE
    ELTAMD UV DAILY SPF40 
    zinc oxide and octinoxate sunscreen lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2289
    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
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72043-2289-148 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
    2NDC:72043-2289-22 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(72043-2289)