BABY BUM MINERAL SPF50 SUNSCREEN (ZINC OXIDE) STICK [SUN BUM LLC]

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BABY BUM MINERAL SPF50 SUNSCREEN (ZINC OXIDE) STICK [SUN BUM LLC]
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NDC 69039-271-00
Set ID 492c44e3-4369-4367-939b-def1fd87de01
Category HUMAN OTC DRUG LABEL
Packager Sun Bum LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active ingredient

    Zinc oxide 19.2%

    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

    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 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 least every 2 hours • children under 6 months of age: ask a doctor 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 value 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-sleeved shirts, pants, hats, and sunglasses

  • Other information

    • protect this product from excessive heat and direct sun • keep this outer card for complete labeling information

  • Inactive ingredients

    cocos nucifera (coconut) oil, persea gratissima (avocado) oil, limnanthes alba (meadowfoam) seed oil, linum usitatissimum (linseed) seed oil, oryza sativa (rice bran) wax, euphorbia cerifera (candelilla) wax, butyloctyl salicylate, copernicia cerifera (carnauba) wax, ozokerite, butyrospermum parkii (shea butter), oryzanol, fragrance, theobroma cacao (cocoa) seed butter, carthamus tinctorius (safflower) seed oil, jojoba esters, tocopherol, bisabolol

  • Questions?

    call 1-877-978-6286

  • Package Labeling:

    Outer Package frontOuter Package backInner Package

  • INGREDIENTS AND APPEARANCE
    BABY BUM MINERAL SPF50 SUNSCREEN 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-271
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION192 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    RICE BRAN (UNII: R60QEP13IC)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CERESIN (UNII: Q1LS2UJO3A)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GAMMA ORYZANOL (UNII: SST9XCL51M)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69039-271-001 in 1 CARTON06/13/2018
    113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/13/2018
    Labeler - Sun Bum LLC (028642574)
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