Label: ALL WEATHER SPF 15 LIP BALM- zinc oxide stick

  • NDC Code(s): 26052-036-01, 26052-036-02, 26052-036-03, 26052-036-04, view more
    26052-036-05
  • Packager: Burt's Bees
  • 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 December 17, 2018

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

View All Sections
  • ACTIVE INGREDIENTS

    ZINC OXIDE 11%

  • 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 reach 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 Poison Control Center right away.

  • Directions

    Apply liberally 15 minutes before sun exposure.

    Reapply at least every 2 hours.

    Reappy after 40 minutes of swimming or weating.

    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 measuresincluding:

    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 consult a doctor.

  • Inactive Ingredients:

    beeswax, olea europaea (olive) fruit oil, theobroma cacao (cocoa) seed butter, simmondsia chinensis (jojoba) seed oil, isoamyl laurate, butyrospermum parkii (shea) butter, flavor, limnanthes alba (meadowfoam) seed oil, citrus aurantium dulcis (orange) peel wax, jojoba esters, glycine soja (soybean) oil, tocopherol, citric acid, rebaudioside A, polyhydroxystearic acid

  • Other Information:

    Protect this product from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL

    BURTS BEES

    ALL WEATHER SPF 15

    MOISTURIZING LIP BALM

    All Weather Carton

  • INGREDIENTS AND APPEARANCE
    ALL WEATHER SPF 15 LIP BALM 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:26052-036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCOA BUTTER (UNII: 512OYT1CRR)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    JOJOBA OIL (UNII: 724GKU717M)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:26052-036-014.25 g in 1 TUBE; Type 0: Not a Combination Product12/01/2017
    2NDC:26052-036-021 in 1 CARTON12/01/2017
    2NDC:26052-036-014.25 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:26052-036-031 in 1 CARTON12/01/2017
    3NDC:26052-036-014.25 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:26052-036-042 in 1 CARTON12/01/2017
    4NDC:26052-036-014.25 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:26052-036-054 in 1 CARTON12/01/2017
    5NDC:26052-036-014.25 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/01/2017
    Labeler - Burt's Bees (613480946)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!