Label: CUROLOGY THE SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide cream

  • NDC Code(s): 82575-032-00, 82575-032-01
  • Packager: Curology Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 14, 2023

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  • Drug Facts

  • Active Ingredient

    Zinc Oxide 9.4%

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early aging caused by sun Directions
  • 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure.
    • reapply:
    • immediately after towel drying 
    • at least every 2 hours
    • 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: Sun Protection Measures.
    • limit time in the sun, especially from 10 a.m.-2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Other information

    Protect this product from excessive heat and direct sun

  • Inactive Ingredients

    Water, Dimethicone, Propylene Glycol, C12-15 Alkyl Benzoate, Sorbitan Oleate Decylglucoside Crosspolymer, Cetearyl Alcohol, Argania Spinosa Kernel Oil, Ammonium Acryloyldimethyltaurate/VP Copolymer, Tocopheryl Acetate, Glycerin, Squalane, Butyrospermum Parkii (Shea Butter) Extract, Polyster-5, Caprylyl/Capryl Glucoside, Coco-Glucosdie, C14-22 Alcohols, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Triethoxycaprylylsilane, Ethyl Ferulate, C12-20 Alkyl Glucoside, Bisabolol, Sodium Chloride, Phospholipids, Gluconolactone, Benzyl Alcohol, Sodium Benzoate, Chlorophensin, Sorbic Acid, Urea, Phenoxyethanol, Ethylhexylglycerin

  • Package Labeling:20ml

    Outer Package2Inner Package2

  • Package Labeling:40ml

    Outer Package3Inner Package3

  • INGREDIENTS AND APPEARANCE
    CUROLOGY THE SUNSCREEN BROAD SPECTRUM SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82575-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION94 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SQUALANE (UNII: GW89575KF9)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SORBIC ACID (UNII: X045WJ989B)  
    UREA (UNII: 8W8T17847W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82575-032-011 in 1 CARTON07/16/2022
    120 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:82575-032-001 in 1 CARTON07/16/2022
    240 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/16/2022
    Labeler - Curology Inc. (104103284)