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

BABY BUM SPF50 MINERAL SUNSCREEN (ZINC OXIDE) CREAM [SUN BUM, LLC]
PDF | XML

NDC 69039-255-00
Set ID 606d2aea-26c1-44a1-8452-02663b3e51dd
Category HUMAN OTC DRUG LABEL
Packager Sun Bum, LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

  • Active Ingredients

    Zinc oxide 20%

    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 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 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.
  • Other Information

    • protect this product from excessive heat and direct sun.
    • keep outer card for complete directions and warnings
  • Inactive ingredients

    water, cocos nucifera (coconut) oil, butyloctyl salicylate, diheptyl succinate, methyl dihydroabietate, butyrospermum parkii (shea butter), capryloyl glycerin/sebacic acid copolymer, sodium stearoyl glutamate, cetearyl alcohol, theobroma cacao (cocoa) seed butter, sodium hyaluronate, bisabolol, tocopherol, coco-glucoside, microcrystalline cellulose, cellulose gum, cetyl alcohol, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, polyhydroxystearic acid, sodium gluconate, phenoxyethanol, ethylhexylglycerin, citric acid

  • Questions?

    call 1 877-978-6286

  • Package Labeling:

    Tube

  • INGREDIENTS AND APPEARANCE
    BABY BUM SPF50 MINERAL SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-255
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69039-255-0088 mL in 1 TUBE; Type 0: Not a Combination Product10/11/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/11/2017
    Labeler - Sun Bum, LLC (028642574)

Related Drugs