Label: SUNSCREEN COLOR BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 17, 2023

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  • Drug Facts

  • Active ingredients

    Titanium Dioxide 10%

    Zinc Oxide 5%

    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 liberally and evenly 15 minutes before sun exposure
    • apply to all skin exposed to the sun
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • 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
  • Other information

    • protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    Water, Human Umbilical Mesenchymal Stem Cell Exosomes, Oat (Avena sativa) Extract, Stearic Acid, Sorbitan Stearate, Glycerin, Iron Oxide, Hydroxyacetophenone, Fragrance

  • Package Labeling:

    Label0

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN COLOR BROAD SPECTRUM SPF 50 
    titanium dioxide, zinc oxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83802-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE100 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    OAT (UNII: Z6J799EAJK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83802-001-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/01/2023
    Labeler - CryoGen, LLC (127842726)
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