Label: LARKLY SPF30 MINERAL POWDER FACE SUNSCREEN- titanium dioxide and zinc oxide powder

  • NDC Code(s): 79287-0000-1, 79287-0000-2, 79287-0000-3, 79287-0000-4
  • Packager: LARKLY, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 11, 2023

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  • Drug Facts

    Active Ingredient...........................Purpose

    Titanium Dioxide 21.00%..................Sunscreen

    Zinc Oxide 15.00%..........................Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun
  • Warnings

    For external use only

  • DO NOT USE

    Do not use on damaged or borken skin

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove

  • STOP USE

    Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:   
    • after 80 minutes of swimming or sweating
    • immediately after towel drying 
    • at least every 2 hours
    • children under 6 months: Ask a doctor   

  • Inactive Ingredients

    Alpha-Tocopherol, Caprylic/Capric Triglyceride, Capryloyl Glycerin, Ceramide I, Ceramide II, Ceramide III, Ethylhexylglycerin, Fumed Silica, Glycyrrhiza Glabra, Green Tea Leaf, Iron Oxide Black, Iron Oxide Red, Iron Oxide Yellow, Kaolin, Magnesium Hydroxide, Maranta Arundinacea Root, Mica, Glyceryl Caprylate, Glycerin, Caprylhydroxamic Acid, Resveratol, Sebacic Acid Copolymer, Tapioca Starch

  • Questions or Comments?

    Call toll free:  1-888-426-4160

  • PRINCIPAL DISPLAY PANEL

    6g brush box label

  • PRINCIPAL DISPLAY PANEL

    brush label

  • PRINCIPAL DISPLAY PANEL

    6g refill box label

  • PRINCIPAL DISPLAY PANEL

    refill bottle label

  • INGREDIENTS AND APPEARANCE
    LARKLY SPF30 MINERAL POWDER FACE SUNSCREEN 
    titanium dioxide and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79287-0000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.212 kg  in 1 kg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.15 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HEXAMETHYLDISILAZANE (UNII: H36C68P1BH)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A)  
    MICA (UNII: V8A1AW0880)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    RESVERATROL (UNII: Q369O8926L)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79287-0000-21 in 1 BOX07/10/2020
    1NDC:79287-0000-10.006 kg in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    2NDC:79287-0000-41 in 1 BOX07/10/2020
    2NDC:79287-0000-30.006 kg in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/10/2020
    Labeler - LARKLY, LLC (042886441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(79287-0000)
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