BABY NOURISHING MINERAL (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BURT'S BEES]

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BABY NOURISHING MINERAL (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BURT'S BEES]
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NDC 26052-037-01
Set ID 7c34d9d0-4392-1044-e053-2991aa0adab1
Category HUMAN OTC DRUG LABEL
Packager BURT'S BEES
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    Titanium Dioxide 2.8%

    Zinc Oxide 13%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a Doctor if a rash occurs.

  • DOSAGE & ADMINISTRATION

    • Apply liberally 15 minutes before sun exposure.

    Reapply

    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every two hours

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a suncreen 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

  • INACTIVE INGREDIENT

    Inactive Ingredients: water, dicaprylyl ether, carthamus tinctorius (safflower) oleosomes, caprylic/capric triglyceride, glycerin, beeswax, cetyl alcohol, nelumbo nucifera flower wax, lonicera japonica (honeysuckle) flower extract, lonicera caprifolium (honeysuckle) flower extract, glycine soja (soybean) oil, prunus armeniaca (apricot) fruit extract, pyrus malus (apple) fruit extract, cocos nucifera (coconut) fruit extract, coffea arabica (coffee) seed extract, dipteryx odorata seed extract, vanilla planifolia fruit extract, isostearic acid, polyhydroxystearic acid, alumina, lecithin, polyglyceryl-3 polyricinoleate, gluconic acid, tocopherol, citric acid, stearic acid, sodium phytate, alcohol, phenoxyethanol, sodium benzoate, potassium sorbate

  • Other Information

    Protect this product from excessive heat and direct sun.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Burt's Bees Baby

    nourishing

    mineral

    sunscreen

    with Vitamin E

    SPF 30

    Water Resistant (40 mins)

    Broad Spectrun SPF 30

    (UVA/UVB Protection)

    label

  • INGREDIENTS AND APPEARANCE
    BABY NOURISHING MINERAL 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:26052-037
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.8 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT (UNII: 3RT3536DHY)  
    APRICOT (UNII: 269CJD5GZ9)  
    APPLE (UNII: B423VGH5S9)  
    ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
    DIPTERYX ODORATA SEED (UNII: D43A5L1U6L)  
    VANILLA (UNII: Q74T35078H)  
    ALCOHOL (UNII: 3K9958V90M)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    LONICERA JAPONICA TOP (UNII: 60Q6UP226V)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    DIDECYL ETHER (UNII: DA81HI310Z)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    NELUMBO NUCIFERA FLOWER WAX (UNII: U01S6C427I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    GLUCONIC ACID (UNII: R4R8J0Q44B)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LONICERA CAPRIFOLIUM FLOWERING TOP (UNII: 1X0T378SXY)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:26052-037-0185 g in 1 TUBE; Type 0: Not a Combination Product12/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/01/2016
    Labeler - BURT'S BEES (613480946)
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