Label: MINERAL TINTED SPF 30 MINERAL TINTED SPF 30 BROAD SPECTRUM SUNSCREEN WATER RESISTANT (80 MIN)- titanium dioxide and zinc oxide cream

  • 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 7, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium Dioxide 2%Sunscreen
    Zinc Oxide 17%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

    Stop use and ask a doctor if rash occurs

    When using this product keep out of eyes. Rinse with water to remove.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • Children under 6 months: Ask a doctor
    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10a.m.-2p.m.
      • Wear long-sleeved shirts, pants, hats and sunglasses
  • Other Information

    Shake well. Rub in well.

    • Protect the product in this container from excessive heat and direct sunlight
    • May stain some fabrics
    • You may report serious adverse reactions to: Report Reaction LLC PO Box 611, Pompton Plains, NJ 07444
  • Inactive Ingredients

    Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Glyceryl Isostearate, Polysilicone-15, Tetrahexyldecyl Ascorbate (Vitamin C), Camellia Sinensis Leaf Extract (Green Tea), Punica Granatum Extract (Pomegranate), Vaccinium Macrocarpon (Cranberry) Fruit Extract, Silica, Polyhydroxystearic Acid, May Contain: (CI 77891, CI 77492, CI 77491, CI 77499)

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    MDSOLARSCIENCES CORP.
    GREENS FARMS, CT 06838

  • PRINCIPAL DISPLAY PANEL - 50 ML Tube Carton

    MDSOLARSCIENCES®

    MINERAL
    TINTED CRÈME

    Broad Spectrum SPF 30
    Water Resistant (80 Min)
    100% Mineral Sunscreen

    SPF 30

    Natural Protection
    with a Sheer, Matte Finish

    TINTED

    DERMATOLOGIST
    DEVELOPED

    CRANBERRY
    GREEN TEA

    POMEGRANATE
    VITAMIN C

    1.7 FL OZ / 50 ML

    PRINCIPAL DISPLAY PANEL - 50 ML Tube Carton
  • INGREDIENTS AND APPEARANCE
    MINERAL TINTED SPF 30   MINERAL TINTED SPF 30 BROAD SPECTRUM SUNSCREEN WATER RESISTANT (80 MIN)
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-571
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide20 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide170 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Dimethicone (UNII: 92RU3N3Y1O)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POMEGRANATE JUICE (UNII: 99S671U9KB)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    May containFERRIC OXIDE RED (UNII: 1K09F3G675)  
    May containFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-571-011 in 1 CARTON07/01/2023
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/01/2023
    Labeler - MDSolarSciences (013647301)
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