Label: PERSONALIZED DAY MOISTURIZER WITH SPF- titanium dioxide, 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

    Titanium Dioxide 2%

    Zinc Oxide 1%

    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.

    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 swimming or sweating Immediately after towel drying.
    • Children under 6 months of age: Ask a doctor. Use water resistant sunscreen if swimming or sweating.
    • 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 (Aqua), Butyloctyl Salicylate, Octyldecyl Neopentanoate, Ethylhexyl Isononanoate, Polyester-7, Glycerin, Neopentyl Glycol Diheptanoate, Cetyl Alcohol, Glyceryl Stearate, Squalane, Phenoxyethanol, PEG-75 Stearate, Bisbolol, Hydrolyzed Sodium Hyaluronate, Pyrus Malus (Apple) Fruit Extract, C12-15 Alkyl Benzoate, Lysolecithin, Sclerotium Gum, Dimethiconol/Caprylylsilsesquioxane/ Silicate Crosspolymer, Allantoin, Ceteth-20, Steareth-20, Caprylyl Glycol, Triceteareth-4 Phosphate, Pullulan, Xanthan Gum, Sodium Hyaluronate,  Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer, Disodium EDTA, Trilaureth-4 Phosphate, Ethylhexylglycerin, Hexylene Glycol, Dicrateria Rotunda Oil, Ruttnera Lamellosa Oil, Lecithin, Silica, Avena Sativa (Oat) Kernel Extract, Camellia Sinensis Leaf Extract, Sodium  Ascorbate, Potassium Sorbate, Tocopherol.

  • Other Information

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

    Label3

  • INGREDIENTS AND APPEARANCE
    PERSONALIZED DAY MOISTURIZER WITH SPF 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73572-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    POLYESTER-7 (UNII: 0841698D2F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SQUALANE (UNII: GW89575KF9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    APPLE (UNII: B423VGH5S9)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CETETH-20 (UNII: I835H2IHHX)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    DICRATERIA ROTUNDA OIL (UNII: Z0DWU9R4GM)  
    RUTTNERA LAMELLOSA OIL (UNII: 5XZ38R4SUT)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    OAT (UNII: Z6J799EAJK)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73572-002-3030 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)