Label: SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion

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

Drug Label Information

Updated December 12, 2023

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  • Drug Facts

  • Active Ingredients

    Titanium Dioxide 3.64%

    Zinc Oxide 2.98%

    Purposes

    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

    ir rash occurs

    Keep out of reach of children.

  • Directions

    • Apply generously 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use a water-resistant sunscreen if swimming or sweating
    • Children under 6 months of age: Ask a doctor
  • Other Information

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

    Water, Diemthicone, Caprylic/Capric Triglyceride, Glycerin, Aloe Barbadensis Leaf Juice, Niacinamide, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Fragrance, Rubus Idaeus(Raspberry) Seed Extract, Chondrus Crispus Extract, Oryza Sativa (Rice) Extract, Spirulina Platensis Extract, Spirulina Maxima Extract, Panax Ginseng Root Extract, Alumina, Hyaluronic Acid, Leuconostoc/Radish Root Ferment Filtrate, Sodium Potassium Aluminum Silicate, Polyhydroxystearic Acid, Stearic Acid, Triethoxycaprylylsilane, Superoxide Dismutase, Soybean Peroxidase, Hydrogenated Lecithin, Hydrogenated Phosphatidylcholine, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Aminomethyl Propanol, Titanium Dioxide, Xanthan Gum, Sodium Carbomer, Citric Acid

  • Package Labeling:

    Outer Package4Inner Package4

  • INGREDIENTS AND APPEARANCE
    SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14268-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE364 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION298 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    RICE GERM (UNII: 7N2B70SFEZ)  
    ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14268-120-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/01/2023
    Labeler - ENGLEWOOD LAB, INC. (172198223)
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