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| Product NDC Code | 14222-0000 | ||||
|---|---|---|---|---|---|
| Drug Name | Rodan fields soothe 4 mineral sunscreen broad spectrum spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Rodan & Fields | ||||
| 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 2% Zinc Oxide 12%
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 a generous dime-sized amount evenly over the entire face every morning as the final step in the Regimen. Reapply every 2 - 3 hours as needed. Avoid the eye area. Children under 6 months of age: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: Alumina, Aluminum Starch Octenylsuccinate, Butylene Glycol, Camellia Sinesis Extract, Caprylyl Glycol, Caprylyl Methicone, Cyclopentasiloxane, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipotassium Glycyrrhizate, Disodium EDTA, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Hydrolyzed Wheat Protein/PVP Crosspolymer, Methicone, Panthenol, PEG-10 Dimethicone, Phenoxyethanol, Silica, Sodium Chloride, Sodium Hyaluronate, Sodium PCA, Tocopheryl Acetate, Water
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: To protect from sunburn and sun-induced skin irritations.
Purpose
Information about the drug product’s indications for use.PURPOSE Sunscreens
Spl product data elements
Usually a list of ingredients in a drug product.RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30 TITANIUM DIOXIDE ALUMINUM OXIDE ALUMINUM STARCH OCTENYLSUCCINATE CAMELLIA SINENSIS FLOWER CAPRYLYL GLYCOL CAPRYLYL TRISILOXANE CYCLOMETHICONE 5 DIMETHICONE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) GLYCYRRHIZINATE DIPOTASSIUM EDETATE DISODIUM DISTEARDIMONIUM HECTORITE ETHYLHEXYLGLYCERIN GLYCERIN LICORICE HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) PANTHENOL PHENOXYETHANOL SILICON DIOXIDE SODIUM CHLORIDE HYALURONATE SODIUM SODIUM PYRROLIDONE CARBOXYLATE .ALPHA.-TOCOPHEROL ACETATE WATER TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE
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.RODAN + FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30 50ml (14222-0000-1) BottleLabel OuterLabel
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.RODAN + FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30
OTHER INFORMATION Protect this product from excessive heat and direct sun.
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.Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
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.
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.
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. Stop use and ask a doctor If rash occurs. When using this product keep out of eyes. Rinse with water to remove. 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