Label: ELTAMD UV FACIAL SPF30 PLUS- zinc oxide and octinoxate sunscreen lotion

  • NDC Code(s): 72043-2283-2, 72043-2283-3, 72043-2283-4
  • Packager: CP Skin Health Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 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. Rinse with warm 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 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. 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 another sun protection measures including: limit time in the sun, especially from 10 am - 2 pm wear long-sleeve shirts, pants, hats and sunglasses Children under 6 months: Ask a physician

  • Inactive Ingredients

    purified water, petrolatum, isopropyl palmitate, octyl stearate, glyceryl stearate, cetearyl glucoside, dimethicone, PEG-100 stearate, hydroxyethyl acrylate/sodium acryloyldimethyl tautrate copolymer, polyisobutene, PEG-7 trimethylolpropane coconut ether, sodium hyaluronate, tocopheryl acetate, ployether-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

    UV Facial UC_Page_1
  • INGREDIENTS AND APPEARANCE
    ELTAMD UV FACIAL SPF30 PLUS 
    zinc oxide and octinoxate sunscreen lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2283
    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)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    OCTYL STEARATE (UNII: 772Y4UFC8B)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    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)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72043-2283-385 g in 1 TUBE; Type 0: Not a Combination Product01/10/2018
    2NDC:72043-2283-4114 g in 1 JAR; Type 0: Not a Combination Product01/10/201809/11/2023
    3NDC:72043-2283-22 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(72043-2283)