Label: ELTAMD UV RESTORE TINTED- titanium dioxide and zinc oxide sunscreen lotion

  • NDC Code(s): 72043-2640-1, 72043-2640-2, 72043-2640-3, 72043-2640-4
  • Packager: CP Skin Health Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 10, 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

    Titanium Dioxide 2.0% Sunscreen
    Zinc Oxide 15.0% Sunscreen

  • Keep out of reach of children

    Keep out of reach of children

  • 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.

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Inactive Ingredients

    water, coco-caprylate/caprate, butyloctyl salicylate, octyldodecyl neopentanoate, caprylic/capric triglyceride, methyl glucose sesquistearate, silica, glyceryl stearate, PEG-100 stearate, PEG-20 methyl glycose sesquisterate, phenoxyethanol, triethoxycaprylylsilane, polyhydroxystearic acid, glycerin, saccharide isomerate, glyceryl behenate, xanthan gum, zingiber officiale (ginger) root extract, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, squalene, ethylhexylglycerin, tocopheryl acetate, sclerotium gum, lecithin, pulluan, dimethicone, polysorbate 60, ethylene/methacrylate copolymer, mica, iron oxides

  • Questions?

    Call toll free 1-800-633-8872

  • Labeling

    UV Restore Tinted_Page_1

  • INGREDIENTS AND APPEARANCE
    ELTAMD UV RESTORE TINTED 
    titanium dioxide and zinc oxide sunscreen lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2640
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 g  in 1000 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION150 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ZINGIBER CASSUMUNAR ROOT (UNII: 3NG517NPD8)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
    SQUALANE (UNII: GW89575KF9)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72043-2640-257 g in 1 TUBE; Type 0: Not a Combination Product09/15/2020
    2NDC:72043-2640-42 g in 1 PACKET; Type 0: Not a Combination Product09/15/2020
    3NDC:72043-2640-114 g in 1 BOTTLE; Type 0: Not a Combination Product07/07/2022
    4NDC:72043-2640-348 g in 1 BOTTLE; Type 0: Not a Combination Product06/10/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/15/2020
    Labeler - CP Skin Health Group, Inc. (611921669)
    Registrant - Swiss-American CDMO, LLC (080170933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(72043-2640)
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