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| Product NDC Code | 82141-3161 | ||||||||
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| Drug Name | Toty solaria mineral |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Chipican 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.Active Ingredients Titanium Dioxide 7.0% Zinc Oxide 6.0%
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 Shake well before use Apply liberally 15 minutes before sun exposure Reapply: After 80 minutes of swimming or sweating Immediately after towel drying At least every 2 hours 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 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, Dimethicone, Isododecane, C12-15 Alkyl Benzoate, Hydrogenated Didecene, Butyloctyl Salicylate, Aluminum Hydroxide, Styrene/Acrylates Copolymer, Phenethyl Benzoate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Nylon-12, Calaguala ( Polypodium leucotomos ) Leaf Extract, Ferulic Acid, 3-O-Ethyl Ascorbic Acid, Tocopheryl Acetate, Tocopherol, Cutleaf Grouncherry (Physalis angulata) Extract, Green Tea ( Camellia sinensis) Extract, Plankton ( Chlamydomonas reinhardti ) Extract, Arginine, Melanin, Caprylyl Glycol, Isohexadecane, Disteardimonium Hectorite, Hydrogen Dimethicone, Phenylpropanol, Polyhydroxystearic Acid, Magnesium Sulfate, Dimethicone/PEG-10/15 Crosspolymer, Propanediol, Triethoxycaprylylsilane, Propylene Carbonate, Caprylic/Capric Triglyceride, Panthenyl Triacetate, Butylene Glycol, Propylene Glycol, Ethyl Linoleate, Oleyl Alcohol, Pentylene Glycol, Oxothiazolidine, Dipropylene Glycol, Sodium Citrate, Palmitoyl Hydroxypropyltrimonium Amylopectin/Glycerin Crosspolymer, 1,2-Hexanediol, Lecithin, Sodium Benzoate, Hydrogenated Lecithin, Phenoxyethanol, Ethylhexylglycerin, Iron Oxides (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77491), Ferrosoferric Oxide (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.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.toty Solaria Mineral Titanium Dioxide, Zinc Oxide PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE ISOHEXADECANE POLYHYDROXYSTEARIC ACID STEARATE TRIETHOXYCAPRYLYLSILANE OXOTHIAZOLIDINE FERRIC OXIDE RED TITANIUM DIOXIDE TITANIUM DIOXIDE NYLON-12 ETHYLHEXYLGLYCERIN 3-PHENYL-1-PROPANOL HYDROGENATED DIDECENE BUTYLOCTYL SALICYLATE PHENETHYL BENZOATE TOCOPHEROL PHYSALIS ANGULATA PROPANEDIOL LECITHIN, SOYBEAN HYDROGENATED SOYBEAN LECITHIN PHLEBODIUM AUREUM LEAF DIMETHICONE/PEG-10/15 CROSSPOLYMER FERRIC OXIDE YELLOW ETHYL LINOLEATE OLEYL ALCOHOL GREEN TEA LEAF BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER 1,2-HEXANEDIOL ALUMINUM HYDROXIDE ZINC OXIDE ZINC OXIDE WATER ISODODECANE ARGININE .ALPHA.-TOCOPHEROL ACETATE FERULIC ACID CAPRYLYL GLYCOL PROPYLENE CARBONATE PHENOXYETHANOL PROPYLENE GLYCOL FERROSOFERRIC OXIDE ALKYL (C12-15) BENZOATE BUTYLENE GLYCOL PENTYLENE GLYCOL DIPROPYLENE GLYCOL 3-O-ETHYL ASCORBIC ACID SODIUM BENZOATE MAGNESIUM SULFATE HEPTAHYDRATE HYDROGEN DIMETHICONE (20 CST) ANHYDROUS TRISODIUM CITRATE DISTEARDIMONIUM HECTORITE MEDIUM-CHAIN TRIGLYCERIDES PANTHENOL TRIACETATE, (+)- CHLAMYDOMONAS REINHARDTII MELANIN SYNTHETIC (TYROSINE, PEROXIDE) DIMETHICONE PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER
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.Package Label.Principal Display Panel- Sample NDC 82141-3161-2 (toty Solaria Mineral, Sample) toty. SOLARIA MINERAL SPF 50+ ANTIOXIDANT SUNSCREEN SERUM SERUM ANTIOXIDANTE PROTECTOR SOLAR ..................................................................................... BROAD SPECTRUM SPF 50+ VERY WATER RESISTANT (80 MINUTES) AMPLIO ESPECTRO SPF 50+ MUY RESISTENTE AL AGUA (80 MINUTOS) 0.17 oz/5g Toty Solaria Mineral (Sample)
Package Label.Principal Display Panel NDC 82141-3161-1 (toty Solaria Mineral) toty. SOLARIA MINERAL SPF 50+ ANTIOXIDANT SUNSCREEN SERUM SERUM ANTIOXIDANTE PROTECTOR SOLAR ..................................................................................... BROAD SPECTRUM SPF 50+ VERY WATER RESISTANT (80 MINUTES) AMPLIO ESPECTRO SPF 50+ MUY RESISTENTE AL AGUA (80 MINUTOS) 1.69 fl. oz/50 mL Toty Solaria Mineral
Package Label. Princip[al Display Panel- Travel Size ) NDC 82141-3161-3 (toty Solaria Mineral, Travel Size) toty. SOLARIA MINERAL SPF 50+ ANTIOXIDANT SUNSCREEN SERUM SERUM ANTIOXIDANTE PROTECTOR SOLAR ..................................................................................... BROAD SPECTRUM SPF 50+ VERY WATER RESISTANT (80 MINUTES) AMPLIO ESPECTRO SPF 50+ MUY RESISTENTE AL AGUA (80 MINUTOS) 1.0 fl. oz/30 mL toty Solaria Mineral Travel Size
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Do not expose the product to high temperatures 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 Rash occurs
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