Label: SUN BUM MINERAL SPF30 SUNSCREEN- zinc oxide stick

  • Category: HUMAN OTC DRUG LABEL

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 February 4, 2022

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  • Drug Facts

  • Active ingredient

    Zinc oxide 8%

    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 immediately.

  • 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 

  • Inactive ingredients

    prunus amygdalus dulcis (sweet almond) oil, cera alba (beeswax), simmondsia chinensis (jojoba) seed oil, butyrospermum parkii (shea) butter, euphorbia cerifera (candelilla) wax, fragrance, argania spinosa kernel (argan) oil, caprylic/capric triglyceride, tocopheryl acetate, copernicia cerifera (carnauba) wax, tocopherol, glycine soja (soybean) oil, glyceryl caprylate, bisabolol, polyhydroxystearic acid, polyglyceryl-3-polyricinoleate, isostearic acid, lecithin, glyceryl undecylenate

  • Questions?

    call 1 (877) 978-6286

  • Package Labeling:

    Stick

  • INGREDIENTS AND APPEARANCE
    SUN BUM MINERAL SPF30 SUNSCREEN 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-275
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION80 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69039-275-004.25 g in 1 TUBE; Type 0: Not a Combination Product06/13/2018
    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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