Label: THE DAY FORMULA BROAD SPECTRUM SPF 30 SUNSCREEN- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 11, 2023

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Titanium Dioxide 8.8%

  • Purpose

    Sunscreen

  • Use

    • Helps prevent sunburn
    • If used as directed with other sun protection measures, decreases the risk of skin cancer and early signs of 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 product is swallowed, get medical help or call a Poison Control Center immediately
  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least every 2 hours
    • Use water resistant sunscreen if swimming or sweating.
    • 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 a Broad Spectrum SPF value 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.
    • Children under 6, ask a doctor.
  • Other Information

    Protect this product from excessive heat and direct sun.

  • Inactive Ingredients

    Water, C12-15 Alkyl Benzoate, Propanediol, Benzotriazolyl Dodecyl p-Cresol, Butylene Glycol, Butyloctyl Salicylate, Niacinamide, Polymethylsilsesquioxane, Silica, Aluminum Stearate, Polyhydroxystearic Acid, 1,2-Hexanediol, Pentylene Glycol, Caprylic/Capric Triglyceride, Alumina, Ammonium Acryloyldimethyltaurate/VP Copolymer, Polyacrylate Crosspolymer-6, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Stearoyl Glutamate, Octyldodecanol, Polyisobutene, Hydroxypropyl Methylcellulose Stearoxy Ether, Stearic Acid, Ethylhexylglycerin, Xantham Gum, Echium Plantagineum Seed Oil, Sorbitan Oleate, Caprylic/Capryl Glucoside, t-Butyl Alcohol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Tocopherol

  • SPL UNCLASSIFIED SECTION

    Dist. by DAR Companies
    New York, NY 10001
    and Dublin, Ireland

  • PRINCIPAL DISPLAY PANEL - 35 ML Bottle Carton

    DR.
    ROSSI
    DERM MD
    CLEAN, CLINICAL SCIENCE ™

    THE DAY FORMULA
    BROAD SPECTRUM
    SPF 30 SUNSCREEN
    PA +++
    PROTECTION SOLAIRE
    LARGE SPECTRUM

    PRINCIPAL DISPLAY PANEL - 35 ML Bottle Carton
  • INGREDIENTS AND APPEARANCE
    THE DAY FORMULA BROAD SPECTRUM SPF 30 SUNSCREEN 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80518-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide88 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    Propanediol (UNII: 5965N8W85T)  
    BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)  
    SUNFLOWER OIL UNSAPONIFIABLES (UNII: T7ZE2WA4MB)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80518-123-011 in 1 CARTON09/01/2022
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2022
    Labeler - Dar Companies, LLC (117641085)
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