Label: KIINSUN SUNSCREEN BROAD SPECTRUM SPF50- titanium dioxide, zinc oxide cream

  • 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 June 3, 2020

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  • Drug Facts

  • Active ingredients

    Titanium dioxide 6.5%

    Zinc oxide 6%

    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

    • for sunscreen use
    • apply generously 15 minutes before sun exposure
    • children under 6 months of age: Ask a doctor
    • reapply:
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 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 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 the product in this container from excessive heat and direct sun
  • Inactive ingredients

    Benzoic Acid, Cetyl Alcohol, Chlorophenesin, Deionized Water, Glyceryl Caprylate/Caprate, Glyceryl Stearate, Glycerine, Sorbic Acid Phenoxyethanol, VP/

  • Questions?

    Toll-free 1-844-KIINSUN

  • Package Labeling:

    Package Label

  • INGREDIENTS AND APPEARANCE
    KIINSUN SUNSCREEN BROAD SPECTRUM SPF50 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72431-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE65 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBIC ACID (UNII: X045WJ989B)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72431-001-01165 g in 1 TUBE; Type 0: Not a Combination Product01/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/02/2020
    Labeler - Grupo Pogami, S.A. de C.V. (812811884)