Label: ELTAMD UV SPF35- octinoxate, zinc oxide sunscreen lotion

  • NDC Code(s): 72043-6808-8
  • Packager: CP Skin Health Group, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 31, 2024

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  • 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. If product is swallowed get medical help or contact a Poison Control Center right away.

  • Active ingredients

    Octinoxate 7.5% Sunscreen
    Zinc Oxide 9.0% Sunscreen

  • Indications & Uses:

    Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • Indications & Uses:

    Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • Keep out of reach of children

    Keep out of reach of children

  • Directions

    Apply liberally 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 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

  • Other information:

    Protect this product from excessive heat and direct sun.

  • Inactive ingredients

    water, petrolatum, isopropyl palmitate, ethylhexyl stearate, dimethicone, phenoxyethanol, glyceryl stearate, PEG-100 stearate, oleth-3 phosphate, cetearyl alcohol, cetearyl glucoside, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, polyisobutene, polyether-1, ethylhexylglycerin, PEG-7 trimethylolpropane coconut ether, citric acid, tocopheryl acetate, sodium hyaluronate, triethoxycaprylylsilane

  • Questions?

    Call toll free 1-800-633-8872

  • Labeling

    UV Lotion UC 02291A

  • INGREDIENTS AND APPEARANCE
    ELTAMD UV SPF35 
    octinoxate, zinc oxide sunscreen lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-6808
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION70 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)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    OCTYL STEARATE (UNII: 772Y4UFC8B)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER (UNII: MVJ3AD73GG)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72043-6808-8226 g in 1 TUBE; Type 0: Not a Combination Product05/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/31/2024
    Labeler - CP Skin Health Group, Inc (611921669)
    Registrant - Swiss-American CDMO, LLC (080170933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(72043-6808)
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