FDA.reportPublic FDA data

The Day Formula Broad Spectrum SPF 30 Sunscreen

Manufacturer
Dar Companies, LLC
Effective date
2023-05-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:00

Label at a glance#

ProductThe Day Formula Broad Spectrum SPF 30 Sunscreen
Active ingredientTitanium Dioxide
Label structure10 sections

Dosage and administration

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 fro...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8.8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • For external use only

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If product is swallowed, get medical help or call a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 35 ML Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80518-123-012024-07-30C16284748780-11030e365-4fa8-111a-e063-dadaa90a10e2The Day Formula
80518-123-012024-01-30C16284748780-11030e365-4fa8-111a-e063-dadaa90a10e2The Day Formula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80518-123-01The Day Formula Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONCREAM11
80518-123-01The Day Formula Broad Spectrum SPF 30 Sunscreen30 mL in 1 BOTTLECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80518-123THE DAY FORMULA BROAD SPECTRUM SPF 30 SUNSCREEN (TITANIUM DIOXIDE) CREAM [DAR COMPANIES, LLC]12 package rows20230520_b1d942fe-dd87-45b7-b65e-3a63e8d95de4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80518-12380518-123-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Water059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
Propanediol5965N8W85TIACT
BENZOTRIAZOLYL DODECYL P-CRESOL298PX4M11XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
NIACINAMIDE25X51I8RD4IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ALUMINUM OXIDELMI26O6933IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
OCTYLDODECANOL461N1O614YIACT
STEARIC ACID4ELV7Z65APIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
XANTHAN GUMTTV12P4NEEIACT
ECHIUM PLANTAGINEUM SEED OILPIB7XBU8XWIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
CARDIOSPERMUM HALICACABUM FLOWERING TOPMZP2508BRRIACT
SUNFLOWER OIL UNSAPONIFIABLEST7ZE2WA4MBIACT
TOCOPHEROLR0ZB2556P8IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PENTYLENE GLYCOL50C1307PZGIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ebab8c68-b0fa-4769-9fda-2c54e23f5480b1d942fe-dd87-45b7-b65e-3a63e8d95de42023-05-11WarningsExact identifier
spl id: ebab8c68-b0fa-4769-9fda-2c54e23f5480
spl set id: b1d942fe-dd87-45b7-b65e-3a63e8d95de4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.