Label: SENSIBLE SPF 32 MINERAL SUNSCREEN- 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 May 17, 2022

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  • Active Ingredients

    Zinc Oxide 25%

  • Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses:

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases risk of skin cancer and early skin aging caused by the sun.
  • 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

    Stop use and ask doctor if rash appears

    Keep out of reach of children. If

    product is swallowed, get medical help

    or contact Poison Control Center right

    away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply generously and evenly to all skin exposed to sun 15 minutes before sun exposure
    • 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

    Reapply after:

    • 40 minutes of swimming or sweating
    • Immediately after towel drying
    • at least every 2 hours
  • OTHER SAFETY INFORMATION

    Other Information: Protect this product from excessive heat and direct sun

  • QUESTIONS

    Questions or comments? 888-850-3756 or Kindredbravely.com

  • PRINCIPAL DISPLAY PANEL

    Sensible Mineral Sunscreen PDP

  • INGREDIENTS AND APPEARANCE
    SENSIBLE SPF 32 MINERAL SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82751-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    JOJOBA OIL (UNII: 724GKU717M)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82751-101-0185 g in 1 TUBE; Type 0: Not a Combination Product05/13/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/13/2022
    Labeler - Kindred Bravely (085227654)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kabana Skin Care080237112manufacture(82751-101)
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