Label: EVERYDAY SUN DEFENSE- zinc oxide cream

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

Drug Label Information

Updated January 8, 2024

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

  • Active Ingredient

    Zinc Oxide 9.4%

  • Inactive Ingredient

    Ammonium Acryloyldimethyltaurate/VP Copolymer, Argania Spinosa Kernel Oil, Bisabolol, Butyrospermum Parkii (Shea Butter) Extract, C12-15 Alkyl Benzoate, C12-20 Glucoside, C14-22 Alcohol, Caprylyl/Capryl Glucoside, Cetearyl Alcohol, Coco Glucoside, Dimethicone, Ethyl Ferulate, Ethylhexylglycerin, Ethylhexylglycerin, Glycerin, Hydroxyethyl Acrylate, Phenoxyethanol, Phospholipids, Polyester-5, Propylene Glycol, Sodium Acryloyl Dimethyl Taurate Copolymer, Sorbitan Oleate Decylglucoside Crosspolymer, Squalane, Tocopheryl Acetate, Triethoxycaprylylsi-lane, Urea, Water

  • OTC-Ask Doctor


    Ask a doctor if rash occurs

  • OTC-Do Not Use

    Do not use on damaged or broken skin

  • OTC-Keep Out of Reach of Children

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control right away

  • OTC-Purpose

    Sunscreen

  • OTC-Questions

    +1) 866-322-3010

  • OTC-Stop Use

    Stop use if rash occurs

  • OTC-When using

    When using this product keep out of eyes
    Rinse with water to remove

  • Indications & Usage Section

    High protection against sunburn

  • 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 right away

  • DOSAGE & ADMINISTRATION

    - Apply generously 15 minutes before sun exposure

    - Reapply every 2 hours
    - Use a water-resistant sunscreen if swimming or sweating

  • PRINCIPAL DISPLAY PANEL

    Everyday Sun Defense

  • INGREDIENTS AND APPEARANCE
    EVERYDAY SUN DEFENSE 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83580-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9.4 g  in 9.4 g
    Inactive Ingredients
    Ingredient NameStrength
    ARGAN OIL (UNII: 4V59G5UW9X)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    SQUALANE (UNII: GW89575KF9)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    UREA (UNII: 8W8T17847W)  
    SORBIC ACID (UNII: X045WJ989B)  
    POLYESTER-5 (TG-38) (UNII: 2L9351NW8W)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83580-010-0160 g in 1 TUBE; Type 0: Not a Combination Product04/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/01/2024
    Labeler - Hommerejuvenate, Inc. (080651103)
    Registrant - Hommerejuvenate, Inc. (080651103)
    Establishment
    NameAddressID/FEIBusiness Operations
    DERMACEUTICAL LABORATORIES LIMITED LIABILITY COMPANY078457159manufacture(83580-010)