Label: YOUR NAME COSMETICS MINERAL SHEET TINT BROAD SPECTRUM SPF 20 lotion

  • 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 January 25, 2018

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Titanium Dioxide 5.00%

    Zinc Oxide 5.00%

  • Use

    • 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 docor if rash occurs
    • Keep out of reach of children. If swalled, 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 water resistant sunscreen if swimming or sweathing
    • Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory 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 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.
    • Children under 6 months: ask a doctor
  • Inactive Ingredients

    Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Octyldodecyl Neopentanoate, PEG/PPG-18/18 Dimethicone, Dimethicone, Magnesium Chloride, Potassium Chloride, Sodium Chloride, Zinc Chloride, Lysine, Tocopherol, Tetrahexyldecyl Ascorbate, Magnesium Ascorbyl Phosphate, Retinyl Palmitate, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ginko Biloba Leaf Extract, Panax Ginsing Root Extract, Octyldodecanol, Sodium Hyaluronate, Phytantriol, Glycerin, Triethoxycaprylylsilane, Boron Nitride, Dextrin Palmitate, Palmitic Acid, Mechiecone, Stearic Acid, Aluminum Hydroxide, Hexylene Glycol, Disodium EDTA, Potassium Sorbate, Sodium Dehydroacetate, Caprylyl Glycol, Phenoxyethanol. May Contain (+/-): Mica, Iron Oxides.

  • Other Information

    • Protect this product form excessive heat and direct sun
  • Principal Display Panel

    59735-170-01

  • INGREDIENTS AND APPEARANCE
    YOUR NAME COSMETICS MINERAL SHEET TINT BROAD SPECTRUM SPF 20 
    your name cosmetics mineral sheet tint broad spectrum spf 20 lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59735-170
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    LYSINE (UNII: K3Z4F929H6)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    RETINOL (UNII: G2SH0XKK91)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    CAMELLIA RETICULATA WHOLE (UNII: BS1R5R0GX4)  
    GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)  
    PANAX GINSENG LEAF (UNII: F055A23N6X)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PHYTANTRIOL (UNII: 8LVI07A72W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59735-170-011 in 1 CARTON01/25/2018
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/25/2018
    Labeler - Mana Products (078870292)