Label: TINTED LIP BALM SPF30 SIENNA ROSE- spf30 lip balm stick

  • 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 12, 2023

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  • Drug Facts

    Active Ingredient

    Zinc Oxide 19.5%

  • 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.
  • DOSAGE & ADMINISTRATION

  • Warnings

    For external use only.

    Do not useon damaged or broken skin.

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

    Stop use and ask a doctor if rash occurs.

  • Directions

    • For suncscreen use
    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • 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 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 doctor
  • Other Information

    Protect this product from excessive heat and direct sun.

  • Inactive Ingredients

    Sesamum Indicum (Sesame) Seed Oil, Oleic/Linoleic/Linolenic Polyglycerides, Isoamyl Laurate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Triticum Vulgare (Wheat) Germ Oil, Olea Europaea (Olive) Fruit Oil, Ricinus Communis (Castor) Seed Oil, Glycerin, Helianthus Annuus (Sunflower) Seed Wax, Beeswax, Flavor*, Glyceryl Behenate, Glyceryl Stearate, Hydrogenated Castor Oil, Polyglyceryl-2 Dipolyhydroxystearate, Dioctyldecyl Dimer Dilinoleate, Tocopheryl Acetate, Argania Spinosa Kernel Oil, Polyglyceryl-3 Diisostearate, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Theobroma Grandiflorum Seed Butter, Glyceryl Caprylate, Propanediol, Tocopherol, Bisabolol, Glyceryl Undecylenate, Glycine Soja (Soybean) Oil, Ammonium Glycyrrhizate, Carmine, Iron Oxides.

    * Natural Flavor

  • Questions?

    1-800-849-7112 or www.burtsbees.com

  • KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    Primary label_1

  • INGREDIENTS AND APPEARANCE
    TINTED LIP BALM SPF30 SIENNA ROSE 
    spf30 lip balm stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:26052-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    VANILLA BEAN (UNII: Q74T35078H)  
    SESAME OIL (UNII: QX10HYY4QV)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PIGMENT RED 48 (UNII: 07XHK4SAV6)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
    COCONUT (UNII: 3RT3536DHY)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:26052-100-011 g in 1 CYLINDER; Type 0: Not a Combination Product03/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/01/2022
    Labeler - Burt's Bees Inc. (613480946)
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