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| Product NDC Code | 14222-0001 | ||||||||
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| Drug Name | Rodan - fields essentials body 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 Avobenzone 2% Homosalate 7% Octisalate 4% Octocrylene 1.7%
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: After 40 minutes of swimming or sweating Immediately after towel drying At least every two hours Children under 6 months: Ask a doctor 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: Sun Protection Measures. Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Dipropylene Glycol, Cyclopentasiloxane, Dimethicone, Polyester-8, Alcohol, VP/Eicosene Copolymer, Caprylyl Glycol, Polyacrylate-15, Potassium Cetyl Phosphate, Glyceryl Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrogenated Palm Glycerides, Polyacrylate-17, PEG-100 Stearate, Dipotassium Glycyrrhizate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Cetyl Alcohol, Panthenol, PEG-10 Dimethicone, Methyl Glucose Sesquistearate, Disodium EDTA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Isohexadecane, Polysorbate 80, Xanthan Gum, Phenoxyethanol, Potassium Hydroxide, Fragrance.
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 ), decreases the risk of skin cancer and early skin aging caused by the sun Directions
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.RODAN - FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ISOHEXADECANE POLYSORBATE 80 XANTHAN GUM PHENOXYETHANOL POTASSIUM HYDROXIDE WATER DIPROPYLENE GLYCOL CYCLOMETHICONE 5 DIMETHICONE ALCOHOL CAPRYLYL GLYCOL POTASSIUM CETYL PHOSPHATE GLYCERYL MONOSTEARATE HYDROGENATED PALM GLYCERIDES PEG-100 STEARATE GLYCYRRHIZINATE DIPOTASSIUM TETRAHEXYLDECYL ASCORBATE .ALPHA.-TOCOPHEROL ACETATE CETYL ALCOHOL PANTHENOL EDETATE DISODIUM AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE
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 ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30 WATER RESISTANT (40 MINUTES) RODAN + FIELDS DERMATOLOGISTS 150 mL/5 Fl.Oz.
RODAN + FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30 150ml (14222-0001-1) Tube Label
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 ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30
Other information Protect this product from excessive heat and direct sun.
RODAN - FIELDS ESSENTIALS This non sticky, non whitening formula contains dimethicone for barrier protection and antioxidants to help counter environmental aggressors. Manufactured for Rodan and Fields, LLC San Francisco, CA 94105 Made in USA ESBS150 85-04-0026 Please Recycle visit rodanandfields.com QUESTIONS OR COMMENTS 1-888-995-5656
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 When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a 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