Label: SUN BUM MINERAL SUNSCREEN FACE STICK SPF 50- 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 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

    • 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  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 Protections Measures- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly 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, limnathes alba (meadowfoam) seed oil, persea gratiima (avocado) oil, linum usitatissimum (linseed) seed oil, oryza sativa (rice bran) wax, butyloctyl salicylate, ozokerite, butyrospermum parkii (shea) butter, copernicia cerifera (carn-auba) wax, euphorbia cerifera (candelilla) wax, oryzanol, theobroma cacoa (cocoa) seed butter, carthamus tinctorius (sufflower) seed oil, jojoba esters, tocopherol, bisabolol

  • Questions?

    1-877-978-6286

  • Package Labeling:

    LabelBottle

  • INGREDIENTS AND APPEARANCE
    SUN BUM MINERAL SUNSCREEN FACE STICK SPF 50 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-620
    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
    CERESIN (UNII: Q1LS2UJO3A)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    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:69039-620-011 in 1 BOX02/22/2021
    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 finalpart35202/22/2021
    Labeler - Sun Bum LLC (028642574)
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