Label: ATOMY BB SUNSCREEN- titanium dioxide, zinc oxide cream

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

Drug Label Information

Updated January 31, 2024

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

  • ACTIVE INGREDIENTS

    Titanium Dioxide 8.22%
    Zinc Oxide 5.76%

  • INACTIVE INGREDIENTS

    Aqua/Water/Eau, Butylene Glycol, Cyclopentasiloxane, Isopropyl Palmitate, Almond Oil, Butylene Glycol Dicaprylate/Dicaprate, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyldecyl Myristoyl Methylaminopropionate, Cyclohexasiloxane, Niacinamide, Talc, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Hydrogenated Poly(C6-14 Olefin), Magnesium Sulfate, Phytosqualane, Polyglyceryl-4 Isostearate, Purslane Extract, Iron Oxides, Triethoxycaprylylsilane, Disteardimonium Hectorite, Caprylyl Glycol, Glyceryl Caprylate, Trihydroxystearin, Aminopropyl Dimethicone, Polymethylsisesquioxane, Fragrance (Parfum), Alumina, Tea Leaf Extract, Silica Dimethyl Silylate, Tocopheryl Acetate, Silica, Dimethicone, Marshmallow Leaf/Root Extract, Borage Extract, Lemon Balm Leaf Extract, Rosemary 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

    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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton
    Image of carton
  • INGREDIENTS AND APPEARANCE
    ATOMY BB SUNSCREEN 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52257-1430
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8.22 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5.76 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52257-1430-140 mL in 1 CARTON; Type 0: Not a Combination Product10/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2023
    Labeler - ATOMY CO., LTD. (631154601)
    Registrant - ATOMY CO., LTD. (631154601)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co.,LTD. Gwanjeong 2 factory963271750manufacture(52257-1430)