Label: ALEX MD PHD TINTED MINERAL SUNSCREEN- zinc oxide, titanium dioxide cream

  • NDC Code(s): 78709-002-01
  • Packager: PHYSICIAN LABORATORIES INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 28, 2025

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

  • Active Ingredient

    Zinc Oxide, 20.2%
    Titanium Dioxide, 6.8%

  • 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
  • Warnings

    • For external use only
    • Do not use ondamaged or broken skin.
    • When using this productkeep out of eyes. Rinse with water to remove.
    • Stop use and ask a doctorif rash occurs.
    • Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.
  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply:
    • After 80 minutes of swimmingor 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 this risk, regularly use a sunscreen
    with a broad spectrum SPF of 15 or higher and other sun protection measures including:
       •Limit time in the sun, especially from 10am–2pm.
       •Wear long-sleeved shirts, pants, hats, and sunglasses.

  • Inactive igredients

    Cyclopentasiloxane, Water/Aqua/Eau, Coco-Caprylate /Caprate, Isononyl Isononanoate, Polyglyceryl-3 Polydimethylsiloxyethyl
    Dimethicone, Glycerin, Disteardimonium Hectorite, Aluminum Hydroxide, Stearic Acid, Undaria Pinnatifida Extract, Triethoxysilylethyl
    Polydimethylsiloxyethyl Hexyl Dimethicone, Astrocaryum Tucuma Seed Butter, Butyrospermum Parkii (Shea) Butter, Theobroma Grandiflorum
    Seed Butter, Tetrahexyldecyl Ascorbate, Dunaliella Salina Extract, Bisabolol, Ubiquinone, Ergothioneine,Tremella Fuciformis Sporocarp Extract,
    Tocopheryl Acetate, Betaine, Lavandula Angustifolia (Lavender) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Polyglyceryl-3 Diisostearate, PEG/PPG-18/18 Dimethicone, Caprylyl Glycol, Triethoxycaprylylsilane, Caprylhydroxamic Acid, Squalane, Polyglyceryl-3 Polyricinoleate,
    C12-15 Alkyl Benzoate, Disodium EDTA, Sodium Chloride, Phenoxyethanol, Ethylhexylglycerin, Iron Oxides (CI 77491, 77499, 77492)

  • Other information

    Protect this product from excessive heat and direct sun.

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    ALEX MD PHD TINTED MINERAL SUNSCREEN 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78709-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20.2 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (CI 77891 - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BETAINE (UNII: 3SCV180C9W)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    SQUALANE (UNII: GW89575KF9)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    WATER (UNII: 059QF0KO0R)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)  
    TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  
    ASTROCARYUM VULGARE KERNEL OIL (UNII: 1IQY04O559)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    DUNALIELLA SALINA (UNII: F4O1DKI9A6)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78709-002-011 in 1 CARTON03/19/2025
    165 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/19/2025
    Labeler - PHYSICIAN LABORATORIES INC (078503839)