Label: DERM INSTITUTE DAILY DEFENSE PROTECTION SUNSCREEN BROAD SPECTRUM SPF50- titanium dioxide, zinc oxide lotion

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

Drug Label Information

Updated December 6, 2024

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

  • Drug Facts

  • Active ingredients

    Titanium Dioxide 8.85%

    Zinc Oxide 1.91%

  • 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 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

    if rash occurs.

    Keep out of reach of children.

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

  • Directions

    • Use in the a.m. after serum and before foundation or makeup
    • apply liberally 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
    • 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 value 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
  • Other information

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

  • Questions?

    212-708-3998

  • Inactive ingredients

    Water (Aqua), Isononyl Isononanoate, Butylene Glycol, Caprylic/Capric Triglyceride, Cetyl Ethylhexanoate, Propanediol, Sodium Chloride, Diethylhexyl Carmonate, Stearic Acid, Alumina, Disteardimonium Hectorite, Polyhydroxystearic Acid, Iron Oxides (CI 77492), Phenoxyethanol, Bacopa Monnieri Extract, Lavandula Angustifolia (Lavender) Oil, Polyglyceryl-6 Polyricinoleate, Glycerin, Butyrospermum Parkii (Shea) Butter, Acetyl Tyrosine, Tocopheryl Acetate, Urea, Allantoin, o-Cymen-5-ol, Iron Oxides (CI 77491), Proline, Ethylhexylglycerin, Iron Oxides (CI 77499), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Hydrolyzed Vegetable Protein, Adenosine Triphosphate, Hydroxyethylcellulose, Xanthophylls, PEG-12 Glyceryl Laurate, Rosmarinus Officininalis (Rosemary) Leaf Oil, PEG-35 Castor Oil, PVP, Lecithin, Alteromonas Ferment Extract, Magnesium Ascorbyl Phosphate, Silybum Marianum Extract, Potassium Sorbate, Caprylyl Glycol, Disodium EDTA, Tocopherol, Xanthan Gum, Ergothioneine, Chondrus Crispus Extract

  • Company Information

    Distributed by: Beautcella Inc. New York, NY 10021 USA

    www.DiSkincare.com

  • Product Packaging

    frontback

  • INGREDIENTS AND APPEARANCE
    DERM INSTITUTE DAILY DEFENSE PROTECTION SUNSCREEN BROAD SPECTRUM SPF50 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81521-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE88.5 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    UREA (UNII: 8W8T17847W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ACETYL L-TYROSINE (UNII: DA8G610ZO5)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    WATER (UNII: 059QF0KO0R)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    LUTEIN (UNII: X72A60C9MT)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    BACOPA MONNIERI WHOLE (UNII: DUB5K84ELI)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POVIDONE (UNII: FZ989GH94E)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-12 GLYCERYL LAURATE (UNII: J07WW42G15)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MILK THISTLE (UNII: U946SH95EE)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81521-001-011 in 1 CARTON05/01/2021
    125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2021
    Labeler - Beautcella Inc. (928453625)