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| Product NDC Code | 14222-2251 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Redefine triple defense |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | part352 | ||||||||
| 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 3%, Octisalate 5%, Octocrylene 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 Every AM, apply liberally and evenly over face + neck at least 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and ear y 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 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 1,2-Hexanediol, Alcohol Denat., Aluminum Starch Octenylsuccinate, Aqua/Eau/Water, Benzoic Acid, Beta Vulgaris (Beet) Root Extract, Biosaccharide Gum-4, Butylene Glycol, Butyloctyl Salicylate, Calcium Gluconate, Carnosine, Cetearyl Alcohol, Cetyl Ethylhexanoate, Chlorphenesin, Cynara Scolymus (Artichoke) Leaf Extract, Dehydroacetic Acid, Diglycerin, Dimethicone, Dimethicone Crosspolymer, Disodium EDTA, Disodium Lauriminodipropionate Tocopheryl Phosphates, Fragrance/Parfum, Fructooligosaccharides, Gluconolactone, Glycerin, HDI/Trimethylol Hexyllactone Crosspolymer, Hydrogenated Polyisobutene, Lactic Acid, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Methyl Methacrylate Crosspolymer, Niacinamide, Pentylene Glycol, Phenoxyethanol, Phragmites Karka Extract, Polyacrylate-13, Polyisobutene, Polysorbate 20, Poria Cocos Extract, Potassium Lactate, Propanediol, Red 4 (Cl 14700), Silica, Sodium Acetylated Hyaluronate, Sodium Benzoate, Sodium Chloride, Sodium Polyacryloyldimethyl Taurate, Sodium Stearoyl Glutamate, Sorbitan Isostearate, Tocopherol, Vitis Vinifera (Grape) Juice Extract, VP/Eicosene Copolymer, Yellow 5 (Cl 19140).
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.REDEFINE Triple Defense AVOBENZONE, OCTISALATE, OCTOCRYLENE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE WATER DIMETHICONE HYDROGENATED POLYBUTENE (1300 MW) CETYL ETHYLHEXANOATE NIACINAMIDE PENTYLENE GLYCOL EICOSYL POVIDONE BUTYLOCTYL SALICYLATE GLYCERIN ALCOHOL ALUMINUM STARCH OCTENYLSUCCINATE DIGLYCERIN CETOSTEARYL ALCOHOL PHENOXYETHANOL METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER BUTYLENE GLYCOL SODIUM STEAROYL GLUTAMATE BETA VULGARIS HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER CHLORPHENESIN PROPANEDIOL CARNOSINE EDETATE DISODIUM ANHYDROUS SODIUM ACETYLATED HYALURONATE POLYISOBUTYLENE (2300 MW) POTASSIUM LACTATE DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES CYNARA SCOLYMUS LEAF LACTIC ACID, UNSPECIFIED FORM 1,2-HEXANEDIOL POLYSORBATE 20 SODIUM CHLORIDE SORBITAN ISOSTEARATE BIOSACCHARIDE GUM-4 SILICON DIOXIDE GLUCONOLACTONE SODIUM BENZOATE TOCOPHEROL FD&C RED NO. 4 BENZOIC ACID CALCIUM GLUCONATE DEHYDROACETIC ACID FD&C YELLOW NO. 5
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 REDEFINE 3 AM Triple Defense Cream Broad Spectrum SPF 30 30 mL/1 Fl. Oz. U.S. Principal Display Panel - 30 mL Carton Label
Principal Display Panel - 30 mL Jar Label RODAN + FIELDS REDEFINE 3 AM Triple Defense Cream Broad Spectrum SPF 30 Principal Display Panel - 30 mL Jar 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.Drug Facts
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 a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 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