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| Product NDC Code | 14222-2440 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Soothe daily mineral sunscreen |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| 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 3.6% Zinc Oxide 2.34%
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. Every AM, apply liberally and evenly over face + neck 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply after 40 minutes of swimming or sweating and after towel drying. 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 AM - 2 PM. Wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Acrylates/Dimethicone Copolymer, Aminopropyl Triethoxysilane, Ammonium Hydroxide, Aqua/Eau/Water, Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Gluconate, Caprylic/Capric Triglyceride, Caprylyl Methicone, Cynara Scolymus (Artichoke) Leaf Extract, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dipropylene Glycol, Disteardimonium Hectorite, Ethylhexylglycerin, Gluconolactone, Glycerin, Isododecane, Isostearic Acid, Magnesium Sulfate, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Nylon-12, PEG-9 Polydimethylsiloxyethyl Dimethicone, Pentylene Glycol, Phenethyl Benzoate, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Propanediol, Propylene Carbonate, Rosmarinic Acid, Rutin, Silica, Sodium Benzoate, Sodium Citrate, Stearic Acid, Styrene/Acrylates Copolymer, Tocopherol, Triethylhexanoin.
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. When 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.SOOTHE Daily Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE 3-(TRIETHOXYSILYL)PROPYLAMINE AMMONIA BUTYLENE GLYCOL BUTYLOCTYL SALICYLATE ALKYL (C12-15) BENZOATE CALCIUM GLUCONATE MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL TRISILOXANE CYNARA SCOLYMUS LEAF DIMETHICONE DIMETHICONE/PEG-10/15 CROSSPOLYMER DIPROPYLENE GLYCOL DISTEARDIMONIUM HECTORITE ETHYLHEXYLGLYCERIN GLUCONOLACTONE GLYCERIN ISODODECANE ISOSTEARIC ACID MAGNESIUM SULFATE, UNSPECIFIED FORM NYLON-12 PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE PENTYLENE GLYCOL PHENETHYL BENZOATE PHENOXYETHANOL POLYGLYCERYL-3 PENTARICINOLEATE POLYHYDROXYSTEARIC ACID (2300 MW) PROPANEDIOL PROPYLENE CARBONATE ROSMARINIC ACID RUTIN SILICON DIOXIDE SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM STEARIC ACID TOCOPHEROL TRIETHYLHEXANOIN WATER
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 - 30 mL Carton Label RODAN+FIELDS SOOTHE Daily Mineral Sunscreen Broad Spectrum SPF 30 4 30 mL/ 1 Fl. Oz. U.S. Principal Display Panel - 30 mL Carton Label
Principal Display Panel - 30 mL Tube Label RODAN+FIELDS SOOTHE 4 Daily Mineral Sunscreen Broad Spectrum SPF 30 Principal Display Panel - 30 mL Tube Label
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 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 excessive heat and direct sun.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-888-995-5656
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 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. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if rash occurs. Keep out of reach of children. If 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