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Mineral sunscreen spf 50 - Medication Information

Product NDC Code 51326-125
Drug Name

Mineral sunscreen spf 50

Type Brand
Active Ingredients
Titanium dioxide 225 mg/g
Zinc oxide 240 mg/g
Route TOPICAL
Dosage Form POWDER
Application Number part352
Labeler Name Topiderm, Inc.
Packages
Package NDC Code Description
51326-125-05 1 tube in 1 carton (51326-125-05) / 4 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Purpose Zinc Oxide 24% Sunscreen Titanium Dioxide 22.5% Sunscreen
Active ingredientsPurpose
Zinc Oxide 24%Sunscreen
Titanium Dioxide 22.5%Sunscreen

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 atleast every 2 hours Sun Protection Measures Spending time in the sun increases your risk of skin can cer and early skin aging. To decrease this risk, regularly use a sunscreen with a broa spectrum SPF of 15 or higher & other sunscreen measures including: Limit time in the sun, especially from 10a.m.-2p.m. Wear long-sleeve shirts, pants, hats, & sunglasses Children under 6 months of age: Ask a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Mica, Silica, Caprrylic/Capric Triglyceride, Lauroyl Lusine, Potassium Sorbate, Sodium Benzoate, Undecylenoyl Glycine, Capryloyl Glyccine. Camellia Sinensis Polyphenols, Caffeine, Resveratrol, Tocpheryl Acetatte, Carthamus Tinctorius (Safflower) Seed Oil, Cam llia Sinesis Leaf Extract, Chammomilla Recutita (Matricaria) Flower Extract, Iron Oxides (CI 77489, CI 77492)

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 sunburnIf 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.
Active ingredients Purpose Zinc Oxide 24% Sunscreen Titanium Dioxide 22.5% Sunscreen
Active ingredientsPurpose
Zinc Oxide 24%Sunscreen
Titanium Dioxide 22.5%Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
Mineral Sunscreen SPF 50 Zinc Oxide Titanium Dioxide ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE MICA SILICON DIOXIDE MEDIUM-CHAIN TRIGLYCERIDES LAUROYL LYSINE POTASSIUM SORBATE SODIUM BENZOATE GREEN TEA LEAF CAFFEINE RESVERATROL .ALPHA.-TOCOPHEROL SAFFLOWER OIL CHAMOMILE

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 - 4 g Tube Carton MINERAL POWDER UVA/UVB BROAD SPECTRUM SPF 50 SUN PROTECTION + OIL CONTROL Protects against visible aging Sets makeup and reduces shine Translucent color blurs imperfections BROAD SPECTRUM SPF 50 Net wt. 0.14 oz. (4 g) PRINCIPAL DISPLAY PANEL - 4 g Tube 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

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.
Keeo out of reach of children. If product is swallowed, get medical help or contact 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 ra sh 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. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if ra sh occurs. Keeo out of reach of children. If product is swallowed, get medical help or contact 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