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| Product NDC Code | 14222-2252 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Redefine triple defense |
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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 Avobenzone 2%, Homosalate 6.8%, Octisalate 3.4%, Octocrylene 4.4%
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 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: 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, Aminomethyl Propanol, Aqua/Eau/Water, Benzoic Acid, Benzyl Alcohol, Beta Vulgaris (Beet) Root Extract, Biosaccharide Gum-4, Butylene Glycol, C12-15 Alkyl Benzoate, Calcium Gluconate, Carbomer, Carnosine, Citric Acid, Cynara Scolymus (Artichoke) Leaf Extract, Dehydroacetic Acid, Diglycerin, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium Lauriminodipropionate Tocopheryl Phosphates, Fragrance/Parfum, Fructooligosaccharides, Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lactic Acid, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Niacinamide, Phenoxyethanol, Phragmites Karka Extract, Po yacrylate-13, Polyisobutene, Po ysorbate 20, Polysorbate 60, Poria Cocos Extract, Potassium Lactate, Propanediol, Silica, Sodium Acetylated Hyaluronate, Sodium Benzoate, Sodium Carbomer, Sodium Potassium Aluminum Silicate, Sorbitan Isostearate, Titanium Dioxide (Cl 77891), Tocopherol, Vitis Vinifera (Grape) Juice Extract, Xanthan Gum.
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, HOMOSALATE, OCTOCRYLENE, OCTISALATE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE WATER GLYCERIN ALKYL (C12-15) BENZOATE SILICON DIOXIDE NIACINAMIDE DIMETHICONE HYDROGENATED SOYBEAN LECITHIN DIGLYCERIN BENZYL ALCOHOL TITANIUM DIOXIDE PHENOXYETHANOL BUTYLENE GLYCOL AMINOMETHYLPROPANOL TOCOPHEROL SOYBEAN OIL SODIUM BENZOATE XANTHAN GUM PROPANEDIOL CARBOXYPOLYMETHYLENE CARNOSINE SODIUM ACETYLATED HYALURONATE POLYISOBUTYLENE (2300 MW) CITRIC ACID MONOHYDRATE POTASSIUM LACTATE DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES CYNARA SCOLYMUS LEAF LACTIC ACID, UNSPECIFIED FORM SORBITAN ISOSTEARATE 1,2-HEXANEDIOL POLYSORBATE 20 BIOSACCHARIDE GUM-4 GLUCONOLACTONE POLYSORBATE 60 BENZOIC ACID CALCIUM GLUCONATE DEHYDROACETIC ACID
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 Triple Defense Lotion Broad Spectrum SPF 30 3 AM 30 mL/1 Fl. Oz. U.S. Principal Display Panel – 30 mL Carton Label
Principal Display Panel – 30 mL Bottle Pump Label RODAN + FIELDS REDEFINE Triple Defense Lotion Broad Spectrum SPF 30 3 AM Principal Display Panel – 30 mL Bottle Pump 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.
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