Label: ELTAMD UV LUMINOUS- titanium dioxide, zinc oxide sunscreen lotion

  • NDC Code(s): 72043-2256-1, 72043-2256-3, 72043-2256-7
  • Packager: CP Skin Health Group, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2023

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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.

  • 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.

  • 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.

  • 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.

  • Keep out of reach of children

    Keep out of reach of children

  • Active Ingredients

    Titanium Dioxide 7.2% Sunscreen
    Zinc Oxide 9.0% Sunscreen

  • Other information:

    Protect this product from excessive heat and direct sun.

  • Inactive Ingredients

    water, isopropyl palmitate, ethylhexyl stearate, octyldodecyl neopentanoate, perfluorononly dimethicone, alumina, polyacrylate-13, phenoxyethanol, hydrogen dimethicone, polyisobutene, triethoxycaprylylsilane, oleth-3 phosphate, citric acid, polysorbate 20, sorbitan isostearate, sodium hydroxide, thioctic acid, quercetin, tocopherol, iron oxides

  • Questions?

    Call toll free 1-800-633-8872

  • Labeling

    UV Luminous UC

  • INGREDIENTS AND APPEARANCE
    ELTAMD UV LUMINOUS 
    titanium dioxide, zinc oxide sunscreen lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2256
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE72 g  in 1000 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION90 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    OCTYL STEARATE (UNII: 772Y4UFC8B)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y)  
    QUERCETIN (UNII: 9IKM0I5T1E)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72043-2256-110 g in 1 TUBE; Type 0: Not a Combination Product12/09/202011/14/2023
    2NDC:72043-2256-748 g in 1 TUBE; Type 0: Not a Combination Product12/09/2020
    3NDC:72043-2256-330 g in 1 TUBE; Type 0: Not a Combination Product12/09/202011/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/09/2020
    Labeler - CP Skin Health Group, Inc (611921669)
    Registrant - Swiss-American CDMO, LLC (080170933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(72043-2256)
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