Label: BB BROAD SPECTRUM SPF 15 LIGHT TO MEDIUM- zinc oxide titanium dioxide cream

  • NDC Code(s): 26052-031-01, 26052-031-02, 26052-031-03
  • Packager: Burt's Bees
  • 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 October 3, 2023

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  • Active Ingredients

    Titanium Dioxide 4.7%

    Zinc Oxide 7.0%

  • 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 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

    • Use in the morning after cleansing
    • Apply liberally 15 minutes before sun exposure
    • Children under 6 months: Ask a doctor
    • Use a water resistent sunscreen if swimming or sweating

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early 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 ethe sun, especially from 10 a.m.- 2 p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses
    • reapply at least every 2 hours
    • use a water resistent sunscreen if swimming or sweating
  • INACTIVE INGREDIENT

    Inactive Ingredients: water, glycerin, decyl oleate, isoamyl cocoate, isoamyl laurate, octyldodecanol, polyglyceryl-4 caprate, caprylic/capric triglyceride, cetyl alcohol, helianthus annuus (sunflower) seed oil, polyglyceryl-2 dipolyhydroxystearate, glyceryl stearate citrate, stearic acid, morinda citrifilia fruit extract, beeswax, jojoba esters, mica, iron oxides, silica, sorbitan stearate, stearyl alcohol, behenyl alcohol, sodium carboxymethyl C10-16 alkyl glucoside, lauryl glucoside, magnesium aluminum silicate, xanthan gum, citric acid, isostearic acid, lecithin, polyglyceryl-3polyricinoleate, polyhydroxysteric acid, sodium phytate, trihydroxystearin, alumina, arachidyl alcohol, sorbic acid, alcohol denat., potassium sorbate, sodium benzoate, fragrance*, phenoxyehtanol

    *natural fragrance

  • Other Information:

    • Protect this product from heat and direct sun.
  • Questions?

    (800) 849-7112 or www.burtsbees.com

  • PRINCIPAL DISPLAY PANEL

    BBCramLMCartonBurt's Bees

    BB Cream

    with Noni Extract

    LIGHT/MED

    Broad Spectrum SPF 15

    Net Wt 1.7 oz / 48.1g

  • INGREDIENTS AND APPEARANCE
    BB BROAD SPECTRUM SPF 15 LIGHT TO MEDIUM 
    zinc oxide titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:26052-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.7 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOAMYL COCOATE (UNII: 14OG46E98E)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    DECYL OLEATE (UNII: ZGR06DO97T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    SORBIC ACID (UNII: X045WJ989B)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MORINDA CITRIFOLIA FRUIT (UNII: 7829X3G2X5)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:26052-031-011 in 1 CARTON11/01/2015
    1NDC:26052-031-0248.1 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:26052-031-030.85 g in 1 PACKET; Type 0: Not a Combination Product11/01/201512/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2015
    Labeler - Burt's Bees (613480946)
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