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The day formula broad spectrum spf 30 sunscreen - Medication Information

Product NDC Code 80518-123
Drug Name

The day formula broad spectrum spf 30 sunscreen

Type Brand
Active Ingredients
Titanium dioxide 88 mg/ml
Route TOPICAL
Dosage Form CREAM
Application Number part352
Labeler Name Dar Companies, LLC
Packages
Package NDC Code Description
80518-123-01 1 bottle in 1 carton (80518-123-01) / 30 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Titanium Dioxide 8.8%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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

Purpose

Information about the drug product’s indications for use.
Purpose Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
The Day Formula Broad Spectrum SPF 30 Sunscreen Titanium Dioxide Titanium Dioxide Titanium Dioxide Water ALKYL (C12-15) BENZOATE Propanediol BENZOTRIAZOLYL DODECYL P-CRESOL BUTYLENE GLYCOL BUTYLOCTYL SALICYLATE NIACINAMIDE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) SILICON DIOXIDE ALUMINUM STEARATE MEDIUM-CHAIN TRIGLYCERIDES ALUMINUM OXIDE AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) SODIUM STEAROYL GLUTAMATE OCTYLDODECANOL STEARIC ACID ETHYLHEXYLGLYCERIN XANTHAN GUM ECHIUM PLANTAGINEUM SEED OIL SORBITAN MONOOLEATE TERT-BUTYL ALCOHOL CARDIOSPERMUM HALICACABUM FLOWERING TOP SUNFLOWER OIL UNSAPONIFIABLES TOCOPHEROL 1,2-HEXANEDIOL PENTYLENE GLYCOL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
DRUG FACTS Dist. by DAR Companies New York, NY 10001 and Dublin, Ireland

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on damaged or broken skin

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If product is swallowed, get medical help or call a Poison Control Center immediately

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if rash occurs

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product keep out of eyes. Rinse with water to remove.

Storage and handling

Information about safe storage and handling of the drug product.
Other Information Protect this product from excessive heat and direct sun.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API