THE DAY FORMULA BROAD SPECTRUM SPF 30 SUNSCREEN- titanium dioxide cream 
Dar Companies, LLC

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.

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The Day Formula

DRUG FACTS

Active Ingredient

Titanium Dioxide 8.8%

Purpose

Sunscreen

Use

Warnings

  • 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

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

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
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)

Revised: 5/2023
Document Id: ebab8c68-b0fa-4769-9fda-2c54e23f5480
Set id: b1d942fe-dd87-45b7-b65e-3a63e8d95de4
Version: 1
Effective Time: 20230511
 
Dar Companies, LLC