Label: DAILY FACE SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 8, 2021

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

  • Drug Facts

  • Active ingredient

    Zinc oxide 10% w/w

  • 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

    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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    apply generously and evenly 15 minutes before sun exposure 
    reapply at least every 2 hours
    use a water resistant sunscreen if swimming or sweating
    Sun Protection Measures. 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
    children under 6 months of age: Ask a doctor

  • Other information

    • protect the product in this container from excessive heat and direct sun
    • may stain some fabrics.
  • Inactive ingredients

    Aloe Leaf Juice, Butyloctyl Salicylate, C15-19 Alkane, Isocetyl Stearoyl Stearate, Silica, Undecane, Tridecane, Tribehenin, Jojoba Seed Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Sunflower Seed Oil, Glyceryl Stearate, Tocopheryl Acetate, Grape Seed Oil, Leuconostoc/Radish Root Ferment Filtrate, Glycerin, Lactobacillus, Coconut Fruit Extract, Kakadu Plum Fruit Extract, Hyaluronic Acid, Panthenol, Acacia Gum (Gum arabic), Xanthan Gum, Allantoin

  • Questions?

    +1-800-619-7961
    You may also report serious side effects to this phone number.
    Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    CLEAN.VEGAN.
    • 90% Natural & Naturally-Derived Ingredients
    • Naturally Preserved with Radish Root

    CLEAN BEAUTY.
    SMART FORMULATIONS.
    AMAZING RESULTS.

    Lot No. :
    Expiry Date :

    @lilyana_naturals
    hello@lilyananaturals.com

    www.lilyananaturals.com

    Product expires 12 months after first opening.

    Distributed by
    LilyAna Naturals LLC, PO Box 661,
    Collinsville, MS 39325

  • Packaging

    SUNSCREEN

  • INGREDIENTS AND APPEARANCE
    DAILY FACE SUNSCREEN  BROAD SPECTRUM SPF 30
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81781-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    C15-19 ALKANE (UNII: CI87N1IM01)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    UNDECANE (UNII: JV0QT00NUE)  
    TRIDECANE (UNII: A3LZF0L939)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5)  
    COCONUT (UNII: 3RT3536DHY)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ACACIA (UNII: 5C5403N26O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81781-101-501 in 1 CARTON07/15/2021
    148 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/15/2021
    Labeler - Lilyana Naturals LLC (117942803)