Label: DR.JART EVERY SUN DAY MINERAL SUN SCREEN- zinc oxide, titanium dioxide cream

  • NDC Code(s): 49404-143-02, 49404-143-03
  • Packager: Have & Be Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 20, 2024

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

  • ACTIVE INGREDIENT

    Zinc Oxide 11.5%

    Titanium Dioxide 4.1%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn

    If used as directed with other sun protection meausres (see Directions), decreases the risk of skin cancer and early skin aging casued by the sun

  • DOSAGE & ADMINISTRATION

    • 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 value of 15 or higher and other sun protection measures including: 

    – Limit time in the sun, especially from 10 am - 2 pm

    – Wear long-sleeved shirts, pants, hats and
    sunglasses

    • Children under 6 months: Ask a doctor

  • 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 using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    Water, CYCLOPENTASILOXANE, PROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, LAURYL POLYGLYCERYL-3POLYDIMETHYLSILOXYETHYL DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, BUTYLOCTYL SALICYLATE, CAPRYLYL METHICONE, 1,2-HEXANEDIOL, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, STEARIC ACID, ALUMINUM HYDROXIDE, POLYGLYCERYL-3, POLYDIMETHYLSILOXYETHYLDIMETHICONE, TRIETHOXYCAPRYLYLSILANE, SORBITAN CAPRYLATE, CITRUS AURANTIUM DULCIS (ORANGE) OIL, GLYCERYL CAPRYLATE, ETHYLHEXYLGLYCERIN, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, LITSEA CUBEBA FRUIT OIL, TOCOPHEROL

  • OTHER SAFETY INFORMATION

    Protect the product in this container from excessive heat and direct sunlight

    You may report a serious adverse event from use of this product to: Report Reaction, LLC PO Box 22 Plainsboro, NJ 08536-0222

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DR.JART EVERY SUN DAY MINERAL SUN SCREEN 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49404-143
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.05 mg  in 50 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5.75 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49404-143-021 in 1 CARTON10/31/2019
    150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:49404-143-035 mL in 1 TUBE; Type 0: Not a Combination Product12/21/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/31/2019
    Labeler - Have & Be Co., Ltd. (690400408)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.963271750manufacture(49404-143)