Label: PREMIUM NATURAL SUNSCREEN BROAD SPECTRUM SPF 30 BABY BUM- 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 January 5, 2017

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  • ACTIVE INGREDIENT

    Active Ingredients         Purpose

    Zinc Oxide 20%   ........... Sunscreen

  • PURPOSE

    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
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Stop used and ask a doctor if rash occurs

  • WARNINGS

    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

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply: After 80 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every2 hours
    • 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 form 10 am - 2 pm.
    • Wear long-sleeve shirts, pants, hats, and sunglasses
    • Children under 6 months: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Butyrospermum Parkii (shea) Butter, Caprylic/Capric Triglyceride, Cera Alba, Copernicia Cerifer(Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Blyceryl Isostearate, Polyhydroxystearic Acid, Parfum, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Ricinus Communis (Castor) Seed Oil, Tocopherol

  • PRINCIPAL DISPLAY PANEL

    Premium Natural Sunscreen Stick

    Baby Bum 30

    Broad Spectrum SPF 30

    Water Resistant (80minutes

    .45 OZ / 13 G

    Stick

    carton

  • INGREDIENTS AND APPEARANCE
    PREMIUM NATURAL SUNSCREEN BROAD SPECTRUM SPF 30  BABY BUM
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70157-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEANUT OIL (UNII: O88E196QRF)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70157-007-021 in 1 CARTON04/27/2015
    1NDC:70157-007-0113 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/27/2015
    Labeler - Baxter Laberatories (740537709)
    Registrant - Baxter Laberatories (740537709)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Laberatories740537709manufacture(70157-007)
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