Label: 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 12%

    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 sun.

  • Warnings

    • For external use only

    Do not use

    • on damaged or broken skin

    Stop using 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 • Children under 6 months of age: Ask a doctor

    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

    • Water, Caprylic/Capric Triglyceride, Isoamyl Laurate, Squalane, Butyloctyl Salicylate, Jojoba Esters, Glycerin, Methylpropanediol, Cetyl Alcohol, Glyceryl Stearate, Silica, Polyglyceryl-2 Dipolyhydroxystearate, PEG-75 Stearate, Caprylyl Glycol, Allantoin, Fragrance, Pyrus Malus (Apple) Fruit Extract, Lysolecithin, Sclerotium Gum, Lecithin, Phenylpropanol, Pullulan, Xanthan Gum, Ceteth-20, Steareth-20, Aloe Barbadensis Leaf Juice Powder, Bisabolol, Tetrasodium Glutamate Diacetate, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Tocopherol, Sodium Hydroxide

  • Other Information

    • Protect the product in this container from excessive heat and direct sun.

  • Questions or Comments?

    go to www.provenskincare.comMade in USA from local and imported materialsManufactured for PROVEN, Miami, FL, 33131

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    PERSONALIZED DAY MOISTURIZER WITH SPF 50 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73572-007
    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)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    SQUALANE (UNII: GW89575KF9)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALLANTOIN (UNII: 344S277G0Z)  
    APPLE (UNII: B423VGH5S9)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETETH-20 (UNII: I835H2IHHX)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73572-007-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/01/2022
    Labeler - Proven Skincare (117370905)