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Product NDC Code | 59735-173 | ||||||||||||||||||||||||||
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Drug Name | Your name mineral sheertint broad spectrum spf 20 |
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Type | Brand | ||||||||||||||||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||||||||||||||||
Dosage Form | CREAM | ||||||||||||||||||||||||||
Application Number | M020 | ||||||||||||||||||||||||||
Labeler Name | Mana Product, Inc | ||||||||||||||||||||||||||
Packages |
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Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Titanium Dioxide 5.00% Zinc Oxide 5.00%
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. Use water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: ask a doctor. Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early 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 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water, Cyclopentasiloxane, Butylene Glycol, Titanium Dioxide, Zinc Oxide, Octyldodecyl Neopentanoate, PEG/PPG-18/18 Dimethicone, Dimethicone, Tocopherol, Tetrahexyldecyl Ascorbate, Retinyl Palmitate, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Octyldodecanol, Boron Nitride, Dextrin Palmitate, Palmitic Acid, Methicone, Stearic Acid, Magnesium Chloride, Potassium Chloride, Sodium Chloride, Zinc Chloride, Magnesium Ascorbyl Phosphate, Sodium Hyaluronate, Phytantriol, Glycerin, Triethoxycaprylylsilane, Lysine, Aluminum Hydroxide, Disodium EDTA, Hexylene Glycol, Potassium Sorbate, Sodium Dehydroacetate, Caprylyl Glycol, Phenoxyethanol MAY CONTAIN (+/-): Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)
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.Stop use and ask a doctor if rash occurs.
Purpose
Information about the drug product’s indications for use.PURPOSE Sunscreen active
Spl product data elements
Usually a list of ingredients in a drug product.YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 YOUR NAME MINERAL SHEER TINT FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE OCTYLDODECYL NEOPENTANOATE TOCOPHEROL ASIAN GINSENG CYCLOMETHICONE 5 METHICONE (20 CST) STEARIC ACID POTASSIUM CHLORIDE SODIUM CHLORIDE PHENOXYETHANOL BORON NITRIDE MAGNESIUM CHLORIDE POTASSIUM SORBATE BUTYLENE GLYCOL PEG/PPG-18/18 DIMETHICONE GREEN TEA LEAF CHAMOMILE TRIETHOXYCAPRYLYLSILANE CAPRYLYL GLYCOL MICA PALMITIC ACID WATER GINKGO OCTYLDODECANOL MAGNESIUM ASCORBYL PHOSPHATE HYALURONIC ACID (NON-ANIMAL STABILIZED) PHYTANTRIOL DIMETHICONE TETRAHEXYLDECYL ASCORBATE VITAMIN A PALMITATE DEXTRIN PALMITATE (CORN; 20000 MW) EDETATE DISODIUM HEXYLENE GLYCOL FERRIC OXIDE RED ZINC CHLORIDE GLYCERIN LYSINE ALUMINUM HYDROXIDE SODIUM DEHYDROACETATE ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE
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 Label-carton PDP
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.dosage & admin update
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 swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION Protect this product from exessive heat and direct sun. PDP
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.USE 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.
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.
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