Label: SUZANNE ORGANICS TINTED MINERAL SUNSCREEN BROAD SPECTRUM SPF 25 - BRONZE- zinc oxide cream

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

Drug Label Information

Updated November 14, 2023

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  • Drug Facts

  • Active Ingredient

    Zinc Oxide 22%

    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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure.
    • reapply at least every 2 hours
    • use a water-resistant sunscreen if swimming or sweating
    • 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: Sun Protection Measures.
    • limit time in the sun, especially from 10am-2pm
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Other Information

    • protect this product from excessive heat and direct sun
  • Inactive Ingredients

    Acetyl Tetrapeptide-2, Allantoin, Artemisia Vulgaris Extract, Benzyl Alcohol, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Olivate, Coco-Caprylate, Ethylhexylglycerin, Iron Oxides, Laminaria Digitata Extract, Mixed Tocopherols, Panthenol, Polyhydroxystearic Acid, Saccharide Isomerate, Sorbitan Olivate, Stearyl Octyldodecyl Citrate Crosspolymer, Tetrasodium Glutamate Diacetate, Tocopherol, Water (Aqua), Xanthan Gum, Zingiber Officinale Root Oil.

  • Questions or Comments?

    Call toll free 1-866-222-4620

  • Package Labeling:

    Tube2

  • INGREDIENTS AND APPEARANCE
    SUZANNE ORGANICS TINTED MINERAL SUNSCREEN BROAD SPECTRUM SPF 25 - BRONZE 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15435-310
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION220 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    ACETYL TETRAPEPTIDE-2 (UNII: M24S4WZS8J)  
    ALLANTOIN (UNII: 344S277G0Z)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15435-310-0460 mL in 1 TUBE; Type 0: Not a Combination Product10/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2022
    Labeler - SLC Skincare (117453517)
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