Label: ELTA MD SKINCARE UV STICK BROAD SPECTRUM SPF50- zinc oxide stick

  • NDC Code(s): 72043-0495-1, 72043-0495-2
  • Packager: CP Skin Health Group, Inc
  • Category: HUMAN OTC DRUG LABEL

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 November 3, 2022

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  • Active ingredients

    Zinc Oxide 22.0%

    Purpose

    Sunscreen

  • Uses

    •   helps prevent sunburn
    • if used as directed with other sun protection measures (see ​Directions​),  decreases the risk of UV damage 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 physician

    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 liberally 15 minutes before sun exposure
    reapply: after 80 minutes of swimming or sweating: immediately after towel drying: at lear every 2 hours
    Sun Protection Measures

    Spending time in the sun can increase your riske of skin cancer and early skin aging.
    To decrease this risk regularly use a sunscreen with a broad spectrum SPF 15 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-sleeve shirts, pants, hats, and sunglasses
    children under 6 months:Ask a physician

  • Other Information

    • Protect this product from excessive heat and direct sun
  • Inactive ingredients

    Caprylic/Capric Triglyceride, Helianthys Annuus (Sunflower) Seed Wax, Cerearyl Nonanoate, Theobroma Cacao Cocoa) Seed Butter, Butyloctyl Salicylate, Lauryl Laurate, Polyhydroxystearic Acid, Euphorbia Cerifera (Candelilla) Was, Capryloyl Glycerin/Sebacic Acid Copolymer, Mica, Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Oryzanol, Ethyl Ferulate, Isostearic Acid, Lecithin, Polyglyceryl-3 Plyricinoleate, Bisabolol, Tocopherol, Silica

  • PRINCIPAL DISPLAY PANEL

    elta MD® Skincare

    UV STICK

    BROAD-SPECTRUM SPF 50+

    net wt 1.3oz (37 g)

    UVstickCtn

  • INGREDIENTS AND APPEARANCE
    ELTA MD SKINCARE UV STICK BROAD SPECTRUM  SPF50
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-0495
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION22 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    CETEARYL NONANOATE (UNII: F6ZWV2F361)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    MICA (UNII: V8A1AW0880)  
    BEHENYL BEHENATE (UNII: K8NU647RJ0)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ORYZANOL (UNII: SST9XCL51M)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72043-0495-21 in 1 CARTON12/01/2021
    1NDC:72043-0495-137 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2021
    Labeler - CP Skin Health Group, Inc (611921669)