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| Product NDC Code | 54031-020 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Max mineral |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| Application Number | M020 | ||||||
| Labeler Name | Peter Thomas Roth Labs, LLC | ||||||
| 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.Titanium Dioxide I.93% Zinc Oxide 19.24%
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 a 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 this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m. wear long•sleeved shirts, pants, hats, and 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 Water, Butyloctyl Salicylate, C9- 12 Alkane, Carthamus Tinctorius (Safflower) Oleosomes, lsodecyl Neopentanoate, Dicaprylyl Carbonate, Cetyl Alcohol, Coco-Caprylate/ Caprate, Propanediol, Ethylhexyl Olivate, Glyceryl Stearate, PEG-I00 Stearate, Cetearyl Olivate, Stearyl Phosphate, Triethoxycaprylylsilane, Phenoxyethanol, Oleth•3 Phosphate, Sorbitan Olivate, HDI/Trimethylol Hexyllactone Crosspolymer, Alumina, Xanthan Gum, Polymethylsilsesquioxane, Polyhydroxystearic Acid, Squalane, Gluconolactone, Sodium Phytate, lsopropyl Titanium Triisostearate, Sodium Benzoate, Hydrogen Dimethicone, Potassium Sorbate, Silica, Tocopheryl Acetate, Ascorbic Acid, Diamond Powder, Iron Oxides, Mica
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 lf used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skinaging caused by the sun
Purpose
Information about the drug product’s indications for use.Active Ingredients.............................................................. Purpose Titanium Dioxide I.93%................................................... Sunscreen Zinc Oxide 19.24%..... ................................................... Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Max Mineral Titanium Dioxide, Zinc Oxide TRIETHOXYCAPRYLYLSILANE MICA C9-12 ALKANE CARTHAMUS TINCTORIUS SEED OLEOSOMES STEARYL PHOSPHATE SODIUM BENZOATE ZINC OXIDE ZINC OXIDE ISOPROPYL TITANIUM TRIISOSTEARATE ISODECYL NEOPENTANOATE COCO-CAPRYLATE/CAPRATE GLYCERYL MONOSTEARATE CETYL ALCOHOL PHENOXYETHANOL HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER SILICON DIOXIDE DIAMOND PHYTATE SODIUM FERRIC OXIDE YELLOW POLYHYDROXYSTEARIC ACID (2300 MW) FERROSOFERRIC OXIDE .ALPHA.-TOCOPHEROL ACETATE XANTHAN GUM POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) FERRIC OXIDE RED POTASSIUM SORBATE ETHYLHEXYL OLIVATE OLETH-3 PHOSPHATE BUTYLOCTYL SALICYLATE DICAPRYLYL CARBONATE PEG-100 STEARATE CETEARYL OLIVATE TITANIUM DIOXIDE TITANIUM DIOXIDE PROPANEDIOL WATER SORBITAN OLIVATE ALUMINUM OXIDE SQUALANE GLUCONOLACTONE HYDROGEN DIMETHICONE (13 CST) ASCORBIC ACID TINTED TAN
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.Max mineral Max mineral
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Question or comments? Call toll free 1-800-PTR-SKIN (787-7546)
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 aska doctor if rash occurs. 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