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Epionce daily shield tinted spf 50 - Medication Information

Product NDC Code 42673-005
Drug Name

Epionce daily shield tinted spf 50

Type Brand
Active Ingredients
Titanium dioxide .048 g/g
Zinc oxide .093 g/g
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name Episciences, Inc.
Packages
Package NDC Code Description
42673-005-00 6 g in 1 tube (42673-005-00)
42673-005-02 1 bottle, pump in 1 box (42673-005-02) / 50 g in 1 bottle, pump (42673-005-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Titanium Dioxide 4.8% Zinc Oxide 9.3%

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: after 80 minutes of swimming or sweating immediately after towel drying at least every two hours children under 6 months: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this 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 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Cyclopentasiloxane, Water, Dimethicone Crosspolymer, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Polymethylsilsesquioxane, Caprylyl Methicone, PEG-10 Dimethicone, Argania Spinosa Kernel Oil, Glycerin, Disteardimonium Hectorite, Isododecane, Tocopheryl Acetate, Alumina, Bisabolol, Caprylyl Glycol, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Extract, Hexylene Glycol, Hydrogen Dimethicone, Iron Oxides (C.I. 77491), Iron Oxides (C.I. 77492), Iron Oxides (C.I. 77499), Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Oryza Sativa (Rice) Bran Extract, PEG/PPG-18/18 Dimethicone, Phenoxyethanol, Propylene Carbonate, Pyrus Malus (Apple) Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silica, Sodium Chloride, Tocopherol, Triethoxycaprylylsilane.

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.
Uses helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin 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.
Epionce Daily Shield Tinted SPF 50 Titanium Dioxide, Zinc Oxide CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) CYCLOMETHICONE 5 DISTEARDIMONIUM HECTORITE ETHYLHEXYLGLYCERIN FERRIC OXIDE RED FERRIC OXIDE YELLOW LEVOMENOL PEG/PPG-18/18 DIMETHICONE PEG-10 DIMETHICONE (600 CST) PHENOXYETHANOL POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) PROPYLENE CARBONATE TITANIUM DIOXIDE TITANIUM DIOXIDE FERROSOFERRIC OXIDE GLYCERIN HELIANTHUS ANNUUS FLOWERING TOP HEXYLENE GLYCOL ISODODECANE METHICONE (20 CST) SILICON DIOXIDE TOCOPHEROL TRIETHOXYCAPRYLYLSILANE WATER SODIUM HYDROXIDE RICE BRAN CAPRYLYL GLYCOL ROSEMARY ALPHA-TOCOPHEROL ACETATE SODIUM CHLORIDE DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) ALUMINUM OXIDE APPLE ARGAN OIL BUTYLENE GLYCOL CAPRYLYL TRISILOXANE ZINC OXIDE ZINC OXIDE

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.
Daily Shield Tinted Principal Display Panel

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 contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Call toll free 1-866-374-6623

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 the product in this container 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 Stop use and ask a doctor if rash occurs When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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