Label: PERSONALIZED DAY MOISTURIZER WITH SPF- zinc oxide cream

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

Drug Label Information

Updated November 10, 2023

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

  • Drug Facts

  • Active Ingredients

    Zinc Oxide 12%

    Purpose

    Sunscreen

  • Uses

    • Helps Prevent Sunburn. 
    • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin 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 using 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. Works best on moisturized skin. 
    • Reapply: 
    • After 40 minutes of swimming or sweating Immediately after towel drying. 
    • Children under 6 months of age: Ask a doctor.
    • Limit time in the sun, especially from 10 a.m. – 2 p.m.
    • Wear long sleeved shirts, pants, hats, and sunglasses.

    Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with a Broad- Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures

  • Inactive Ingredients

    Water, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Isododecane, Lauryl PEG-8 Dimethicone, Polymethylsilsesquioxane, Octyldodecyl Neopentanoate, Propanediol, Caprylyl Methicone, Dimethicone, Niacinamide, Dimethiconol/Propylsilsesquioxane/ Silicate Crosspolymer,Trilaureth-4 Phosphate, Allantoin, Bisabolol, Tocopherol, Sodium Chloride, Capryl Glycol, Ethylhexylglycerin, Hexylene Glycol, Phenoxyethanol, Tetrasodium Glutamate Diacetate, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, PEG-10, Sodium Hydroxide

  • Other Information

    • Protect this product from excessive heat and direct sun.
  • Package Labeling:

    Label4

  • INGREDIENTS AND APPEARANCE
    PERSONALIZED DAY MOISTURIZER WITH SPF 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73572-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION120 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ISODODECANE (UNII: A8289P68Y2)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73572-003-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/01/2020
    Labeler - Proven Skincare (117370905)