Label: PROVEN PERSONALIZED DAY MOISTURIZER WITH SPF 50- 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 15%

    Purpose

    Sunscreen

  • 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.

  • Warnings

    For external use only

    Do not use

    • on damaged or broken skin

    Stop use and ask a doctor

    • if rash occurs

    When using this product

    • keep out of eyes. Rinse with water to remove.

    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 • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours •reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months: Ask a doctor • Use water resistant sunscreen if swimming or sweating.

    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. Sun Protection Measures:

  • Inactive Ingredients

    Allantoin, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Alcohol, Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer, Disodium EDTA, Ethylhexyl Isononanoate, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hexylene Glycol, Lysolecithin, Octyldodecyl Neopentanoate, PEG-75 Stearate, Phenoxyethanol, Pullulan, Pyrus Malus (Apple) Fruit Extract, Sclerotium Gum, Silica, Squalane, Trilaureth-4 Phosphate, Water, Xanthan Gum

  • Other Information

    • protect this product from excessive heat and direct sun.

  • Questions or comments?

    Call (650) 427-0836

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    PROVEN PERSONALIZED DAY MOISTURIZER WITH SPF 50 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73572-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    APPLE (UNII: B423VGH5S9)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SQUALANE (UNII: GW89575KF9)  
    TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73572-004-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product02/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/14/2021
    Labeler - Proven Skincare (117370905)