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Product NDC Code | 42508-472 | ||||
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Drug Name | Perfecting liquid foundation buff spf 15 |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | EMULSION | ||||
Application Number | M020 | ||||
Labeler Name | Arbonne International, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Purpose Zinc Oxide 10 % Sunscreen Enter section text here
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 For sunscreen use: apply liberally and evenly 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 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-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Cyclopentasiloxane, Isododecane, Hydrogenated Polydecene, Polyglyceryl-3 Diisostearate, Polymethylsilsesquioxane, Glycerin, HDI/Trimethylol Hexyllactone Crosspolymer, Propanediol, Dimethicone, Hydrogenated Castor Oil, Phenoxyethanol, Magnesium Sulfate, Ribose, Sodium Chloride, Avena Sativa (Oat) Kernel Extract, Ethylhexylglycerin, Sodium Benzoate, Tocopheryl Acetate, Camellia Sinensis (White Tea) Leaf Extract, Caprylic/Capric Triglyceride, Potassium Sorbate, Aminobutyric Acid, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Alaria Esculenta Extract, Buddleja Davidii Extract, Marrubium Vulgare Extract, Thymus Vulgaris (Thyme) Extract, Caprylyl Glycol. May Contain: Titanium Dioxide (CI 77891), Iron Oxide (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)
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 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.Enter section text here
Spl product data elements
Usually a list of ingredients in a drug product.Perfecting Liquid Foundation Buff SPF 15 Zinc Oxide WATER CYCLOMETHICONE 5 ISODODECANE HYDROGENATED POLYDECENE (1500 CST) POLYGLYCERYL-3 DIISOSTEARATE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) GLYCERIN HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER PROPANEDIOL DIMETHICONE HYDROGENATED CASTOR OIL PHENOXYETHANOL MAGNESIUM SULFATE, UNSPECIFIED FORM RIBOSE, D- SODIUM CHLORIDE OAT ETHYLHEXYLGLYCERIN SODIUM BENZOATE .ALPHA.-TOCOPHEROL ACETATE CAMELLIA SINENSIS WHOLE MEDIUM-CHAIN TRIGLYCERIDES POTASSIUM SORBATE .GAMMA.-AMINOBUTYRIC ACID HYALURONATE SODIUM TETRAHEXYLDECYL ASCORBATE ALARIA ESCULENTA BUDDLEJA DAVIDII WHOLE MARRUBIUM VULGARE WHOLE THYMUS VULGARIS WHOLE CAPRYLYL GLYCOL FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE
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.PerfectingUC
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
Instructions for use
Information about safe handling and use of the drug product.Uses helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions of comments? 1.800.272.6663 Monday - Friday 6 a.m. - 6 p.m. Pacific Time.
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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.Distributed by Arbonne International, LLC. Irvine, CA 92618 U.S.A Made in the U.S.A.
Storage and handling
Information about safe storage and handling of the drug product.Other information protect the product in this container 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 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