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| Product NDC Code | 14222-0420 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Rodan and fields reverse 4 broad spectrum spf 50 plus sunscreen |
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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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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Avobenzone 3 % Homosalate 10% Octisalate 5% Octocrylene 2.6%
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 a dime-sized amount evenly over entire face, avoiding the eye area. Use every morning and apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours 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 Children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Dipropylene Glycol, Caprylyl Methicone, Dicaprylyl Carbonate, PEG/PPG-17/6 Copolymer, Potassium Cetyl Phosphate, Methyl Glucose Sesquistearate, Hydrogenated Palm Glycerides, Polyacrylate-15, Polyacrylate-17, Alcohol, Butylene Glycol, Adenosine, Dunaliella Salina Extract, Euterpa Olearacea (Acai) Fruit Extract, Portulaca Olearacea Extract, Morus Alba (Mulberry) Extract, Camellia Sinensis (Green Tea) Leaf Extract, Dipotassium Glycyrrhizate, Panthenol, Tocopheryl Acetate, Caprylyl Glycol, Glyceryl Stearate, Hydrogenated Polydecene, PEG-100 Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Cetyl Alcohol, PEG-10 Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Potassium Hydroxide, Disodium EDTA, 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 AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50 PLUS SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WATER DIPROPYLENE GLYCOL CAPRYLYL TRISILOXANE DICAPRYLYL CARBONATE PEG/PPG-17/6 COPOLYMER POTASSIUM CETYL PHOSPHATE HYDROGENATED PALM GLYCERIDES ALCOHOL BUTYLENE GLYCOL ADENOSINE DUNALIELLA SALINA ACAI PURSLANE WHITE MULBERRY GREEN TEA LEAF GLYCYRRHIZINATE DIPOTASSIUM PANTHENOL .ALPHA.-TOCOPHEROL ACETATE CAPRYLYL GLYCOL GLYCERYL MONOSTEARATE PEG-100 STEARATE ISOHEXADECANE POLYSORBATE 80 CETYL ALCOHOL PHENOXYETHANOL POTASSIUM HYDROXIDE 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 REVERSE 4 Broad Spectrum SPF 50+ Sunscreen RODAN + FIELDS DERMATOLOGISTS 50 mL / 1.7 Fl.Oz.
RODAN AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50+ SUNSCREEN 50ml (14222-0420-1) Inner Label Outer 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 AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50+ SUNSCREEN
Step 4 in the REVERSE Regimen for Brown Spots, Dullness and Sun Damage. Advanced formula prevents future discoloration by shielding pigment-stimulating UV rays. Contains SHIELD sunscreen technology, an exclusive complex of stabilized avobenzone (a key UVA blocker) and colorless carotenoids (free radical fighting antioxidants) to visibly decelerate the signs of photoaging that appear over time. Antioxidants vitamin E and green tea provide additional protection from free radicals, while licorice extract and mulberry help to brighten dull skin. Use as part of the REVERSE Regimen for best results. rf Developed by Stanford trained dermatologists Dr. Katie Rodan and Dr. Kathy Fields. visit rodanandfields.com Manufactured for Rodan and Fields, LLC 11 Maiden Lane, Suite 400, San Francisco, CA 94108. Made in the USA Please Recycle.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS OR COMMENTS 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 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect this product 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 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