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

The Day Formula Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

The Day Formula Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Dar Companies, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

THE DAY FORMULA BROAD SPECTRUM SPF 30 SUNSCREEN 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80518-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	88 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80518-123-01	1 in 1 CARTON	09/01/2022
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2022

Labeler - Dar Companies, LLC (117641085)