Label: ATOMY SUNSCREEN BEIGE BROAD SPECTRUM SPF 50 PLUS- homosalate, octisalate, titanium dioxide, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 16, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    HOMOSALATE 7.50%
    OCTISALATE 4.50%
    TITANIUM DIOXIDE 2.20%
    ZINC OXIDE 12.70%

  • INACTIVE INGREDIENTS

    Aqua/Water/Eau, Cyclopentasiloxane, Dipropylene Glycol, Disiloxane, Lauryl Peg-10 Tris(Trimethylsiloxy)Silylethyl Dimethicone, Glycerin, Niacinamide, Propylheptyl Caprylate, Portulaca Oleracea Extract, Silica, Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Dicaprylyl Carbonate, 1,2-Hexanediol, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Synthetic Fluorphlogopite, Triethoxycaprylylsilane, Aluminum Hydroxide, Stearic Acid, Sorbitan Caprylate, Dimethicone/Peg-10/15 Crosspolymer, Fragrance(Parfum), Iron Oxides(CI 77492), Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Ethylhexylglycerin, Adenosine, Iron Oxides(CI 77491), Iron Oxides(CI 77499), Tocopherol, Camellia Sinensis Leaf Extract, Melissa Officinalis Extract, Centella Asiatica Extract, Perilla Ocymoides Leaf Extract

  • PURPOSE

    Sunscreen

  • 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 doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. 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 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

    • Reapply at least every 2 hours
    • Use a water-resistant sunscreen if swimming or sweating
    • Children under 6 months: Ask a doctor
    • 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 value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m. ‒ 2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses

  • Other Information

    Protect this product from excessive heat and direct sun

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of cartonImage of carton

  • INGREDIENTS AND APPEARANCE
    ATOMY SUNSCREEN BEIGE BROAD SPECTRUM SPF 50 PLUS 
    homosalate, octisalate, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52257-1460
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.5 g  in 60 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.7 g  in 60 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.32 g  in 60 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION7.62 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Dipropylene Glycol (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52257-1460-160 mL in 1 CARTON; Type 0: Not a Combination Product06/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2021
    Labeler - ATOMY CO., LTD. (631154601)
    Registrant - ATOMY CO., LTD. (631154601)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co.,LTD. Gwanjeong 2 factory963271750manufacture(52257-1460)