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Product NDC Code | 72208-353 | ||||
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Drug Name | The ordinary suncare mineral uv filters with antioxidants spf15 |
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Type | Brand | ||||
Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | M020 | ||||
Labeler Name | Deciem Inc | ||||
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Acrtive Ingredients Zinc Oxide (9.76%) Titanium Dioxide (3.74%) Purpose UV Filter
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 liverally and evenly to face 15 minutes before sun exposue for children under 6 months of age: Ask a doctor prior to use. Reapply Reapply at lease every 2 hours use a water resistant sunscreen if swimming or sweating
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Cyclopentasiloxane, PEG-10 Dimethicone, Glycerin, Helianthus Annuus Seed Oil, PEG-9 Polydimethylsiloxyethyl Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Caprylic/Capric Triglyceride, Dimethicone/PEG-10/15 Crosspolymer, Astaxanthin, Disodium Uridine Phosphate, Ethyl Ferulate, Rosmarinus Officinalis Leaf Extract, Tasmannia Lanceolata Fruit/Leaf Extract, Haematococcus Pluvialis Extract, Picea Mariana Bark Extract, Arginine, Aspartic Acid, Glycine, Alanine, Serine, Valine, Isoleucine, Proline, Threonine, Histidine, Phenylalanine, Sodium PCA, PCA, Sodium Lactate, Glucose, Maltose, Fructose, Trehalose, Urea, Allantoin, Sodium Hyaluronate, Linoleic Acid, Oleic Acid, Phytosteryl Canola Glycerides, Palmitic Acid, Stearic Acid, Isochrysis Galbana Extract, Lysolecithin, Lecithin, Triolein, Pentylene Glycol, Dipropylene Glycol, Polyglyceryl-10 Oleate, Polyglyceryl-5 Trioleate, Polyglyceryl-10 Stearate, Tocopherol, Alumina, Citric Acid, Trisodium Ethylenediamine Disuccinate, Sodium Chloride, Sodium Hydroxide, Phenoxyethanol, Chlorphenesin.
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 SPF 30
Purpose
Information about the drug product’s indications for use.Purpose UV Filter
Spl product data elements
Usually a list of ingredients in a drug product.The Ordinary Suncare Mineral UV Filters with Antioxidants SPF15 Zinc Oxide, Titanium Dioxide WATER CYCLOMETHICONE 5 PEG-10 DIMETHICONE (600 CST) GLYCERIN SUNFLOWER OIL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE MEDIUM-CHAIN TRIGLYCERIDES HEXYL LAURATE POLYGLYCERYL-4 ISOSTEARATE ASTAXANTHIN URIDINE MONOPHOSPHATE DISODIUM ETHYL FERULATE ROSEMARY TASMANNIA LANCEOLATA WHOLE HAEMATOCOCCUS PLUVIALIS PICEA MARIANA WHOLE ARGININE ASPARTIC ACID GLYCINE ALANINE SERINE VALINE ISOLEUCINE PROLINE THREONINE HISTIDINE PHENYLALANINE SODIUM PYRROLIDONE CARBOXYLATE PIDOLIC ACID SODIUM LACTATE DEXTROSE, UNSPECIFIED FORM MALTOSE FRUCTOSE TREHALOSE UREA ALLANTOIN HYALURONATE SODIUM LINOLEIC ACID OLEIC ACID CANOLA OIL PALMITIC ACID PENTYLENE GLYCOL STEARIC ACID EGG PHOSPHOLIPIDS GLYCERYL TRIOLEATE DIPROPYLENE GLYCOL POLYGLYCERYL-10 OLEATE POLYGLYCERYL-10 STEARATE TOCOPHEROL ALUMINUM OXIDE CITRIC ACID MONOHYDRATE TRISODIUM ETHYLENEDIAMINE DISUCCINATE SODIUM CHLORIDE SODIUM HYDROXIDE PHENOXYETHANOL CHLORPHENESIN ZINC OXIDE ZINC CATION 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.Principle 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 broked skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs For external use only.
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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Protect the product in this container from excessive heat and direct sun Shake well before using
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 For external use only.
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. Stop use and ask a doctor if rash occurs For external use only.
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 Skin Cancer/Skin Aging Alert; Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Do not use on damaged or broked skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs For external use only.
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