The Day Formula Broad Spectrum Spf 30 Sunscreen
FDA Label NDC 80518-123

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dar Companies, Llc for the product The Day Formula Broad Spectrum Spf 30 Sunscreen (NDC 80518-123). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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DRUG FACTS

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

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

Otc - Do Not Use

  • Do not use on damaged or broken skin

Otc - When Using

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

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

  • 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

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)

Principal Display Panel (35 ML Bottle Carton)

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