Label: BABY BUM DIAPER RASH- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 4, 2022

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  • Drug Facts

  • Active Ingredients

    Zinc oxide 16%

    Purpose

    Skin protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness
  • Warnings

    For external use only

    When using this product

    do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again withing a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • change wet and soiled diapers promptly
    • cleanse the diaper area and allow area to dry
    • apply cream liberally as often as necessary with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged
  • Other Information

    • store between 20° to 25°C (68° to 77°F)
    • do not use if quality seal is broken
  • Inactive ingredients

    ricinus communis (castor) seed oil, hydrogenated castor oil, cocos nucifera (coconut) oil, beeswax, butyrospermum parkii (shea) butter, simmondsia chinensis (jojoba) seed oil, theobroma cacao (cocoa) seed butter, persea gratissima (avocado) oil, aloe barbadensis leaf extract, gardenia taitensis flower extract, tocopherol, hydrogenated vegetable oil

  • Questions?

    1-877-978-6286

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    BABY BUM DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-638
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION160 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    JOJOBA OIL (UNII: 724GKU717M)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69039-638-0285 g in 1 TUBE; Type 0: Not a Combination Product06/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/02/2021
    Labeler - Sun Bum LLC (028642574)
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