Label: UNSUN BROAD SPECTRUM SPF 30 MINERAL- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 58443-0424-3
  • Packager: Prime Enterprises Inc.
  • 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 September 16, 2021

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  • Active ingredients

    Titanium Dioxide 3 %

    Zinc Oxide 3 %

  • 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

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging For external use only.

    Do not useon damaged or broken skin.

    When using this product avoid contact with eyes .

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.

  • Directions

    Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, at least every 2 hours. 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 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.

  • Inactive ingredients

    Allantoin, Alumina, Butyrospermum Parkii (Shea) Butter, Camellia Oleifera (Green Tea) Leaf Extract, Cetyl PEG/PPG-10/1 Dimethicone, Cucumis Sativus (Cucumber) Extract, Cyclopentasiloxane, Dimethicone Crosspolymer, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Hexyl Laurate, Iron Oxides, Lavandula Angustifolia (Lavender) Oil, Linum Usitatissimum (Linseed) Seed Oil, Oenothera Biennis (Evening Primrose) Oil, PEG-10 Dimethicone, Phenoxyethanol, Plankton Extract, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Rosa Canina Seed Oil, Silica, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

  • Other information

    • protect this product from excessive heat and direct sun.
  • Questions or comments?

    info@unsuncosmetics.com

  • Everyday by Unsun Medium Deep Mineral Tinted Face Sunscreen Lotion SPF 30

    Principle Display Label

  • INGREDIENTS AND APPEARANCE
    UNSUN  BROAD SPECTRUM SPF 30 MINERAL
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0424
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE31.26 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE31.26 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    CUCUMBER (UNII: YY7C30VXJT)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    ROSA CANINA SEED (UNII: 4503R1M9UT)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    WATER (UNII: 059QF0KO0R)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    D&C BLACK NO. 2 (UNII: 4XYU5U00C4)  
    Product Characteristics
    Colorbrown (Medium Tan) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0424-350 mL in 1 TUBE; Type 0: Not a Combination Product03/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/04/2019
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0424) , manufacture(58443-0424) , label(58443-0424) , analysis(58443-0424)
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