Label: ELTAMD UV SHEER- zinc oxide and octocrylene sunscreen cream

  • NDC Code(s): 72043-2563-0, 72043-2563-1, 72043-2563-2, 72043-2563-3, view more
    72043-2563-7
  • Packager: CP Skin Health Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 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.

  • Active Ingredients

    Octocrylene 10% Sunscreen
    Zinc Oxide 15% Sunscreen

  • 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.

  • Keep out of reach of children

    Keep out of reach of children

  • Directions

    Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, 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, butyloctyl salicylate, coco-caprylate/caprate, isohexadecane, butylene glycol, isododecane, phenoxyethanol, polyhydroxystearic acid, triethoxycaprylylsilane, polyacrylate crosspolymer-6, acacia Senegal gum, polysilicone-11, xanthan gum, tetrahexyldecyl ascorbate, ethylhexylglycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, squalene, disodium EDTA, polysorbate 60, sodium hyaluronate, sodium hydroxide

  • Questions?

    Call toll free 1-800-633-8872

  • Labeling

    02536 Box- UC EltaMD UV Sheer 1.7oz PDF
  • INGREDIENTS AND APPEARANCE
    ELTAMD UV SHEER 
    zinc oxide and octocrylene sunscreen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION150 g  in 1000 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ISODODECANE (UNII: A8289P68Y2)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ACACIA SENEGAL FLOWER (UNII: 72P931MTC2)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    SQUALANE (UNII: GW89575KF9)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72043-2563-130 g in 1 TUBE; Type 0: Not a Combination Product11/03/202011/09/2023
    2NDC:72043-2563-750 g in 1 TUBE; Type 0: Not a Combination Product11/03/2020
    3NDC:72043-2563-010 g in 1 TUBE; Type 0: Not a Combination Product11/03/2020
    4NDC:72043-2563-22 g in 1 PACKET; Type 0: Not a Combination Product11/03/202011/09/2023
    5NDC:72043-2563-385 g in 1 TUBE; Type 0: Not a Combination Product07/07/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/30/2020
    Labeler - CP Skin Health Group, Inc. (611921669)
    Registrant - Swiss-American CDMO, LLC (080170933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(72043-2563)
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