Label: MINERAL SUNSCREEN SPF-30- titanium dioxide, zinc oxide liquid

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

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active Ingredient

    Titanium Dioxide 6.00% Zinc Oxide 6.00%

    Purpose

    Sunscreen

  • Uses:

    • Helps prevent sunburn. • Higher SPF gives more sunburn protection. • Retains SPF after 80 minutes of swimming or sweating. • 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 consult your doctor

    if a rash or irritation occurs.

    Keep out of reach of children.

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

    If pregnant or breast-feeding,

    ask a health professional before use.

  • Directions:

    • Apply liberally 15 minutes before sun exposure and as needed. • Children under 6 months of age: Ask a doctor. • After 80 minutes of swimming or sweating. • Immediately after towel drying. • At least every 2 hours. 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 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.








    Reapply:Sun Protection Measures: 

  • Other Information

    • Protect the product in this container from excessive heat and direct sun.

  • Other Ingredients:

    *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, *Carthamus Tinctorius (Safflower) Oil, Ethylhexylglycerin, *Glycerin, Glyceryl Stearate Citrate, *Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Stearic Acid, Tetrasodium Glutamate Diacetate, *Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E), Xanthan Gum. 

    *Denotes organic ingredients

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    MINERAL SUNSCREEN SPF-30 
    titanium dioxide, zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83387-399
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    COCOA (UNII: D9108TZ9KG)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83387-399-00177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/17/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/17/2023
    Labeler - NEWCO LLC (117874606)
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