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| Product NDC Code | 42508-820 | ||||
|---|---|---|---|---|---|
| Drug Name | Arbonne agewell moisture restoring broad spectrum spf 15 sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| 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 ingredient Zinc oxide 4.9%
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 children under 6 months of age: Ask a doctor 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, C12-15 alkyl benzoate, glycerin, isononyl isononanoate, steareth-21, caprylic/capric triglyceride, squalane, dimethicone, sodium acryloyldimethyltaurate/VP crosspolymer, sorbitan oleate, steareth-2, aloe barbadensis leaf juice, citrus aurantium dulcis (orange) callus culture extract, cucumis sativus (cucumber) fruit extract, laminaria digitata extract, lavandula stoechas extract, pyrus malus (apple) fruit extract, nasturtium officinale extract, trifolium pratense (clover) flower extract, hippophae rhamnoides oil, olea europaea (olive) fruit oil, sodium hyaluronate, tetrahexyldecyl ascorbate, palmitoyl tripeptide-38, polyglyceryl-3 laurate, gluconolactone, xanthan gum, calcium gluconate, magnesium ascorbyl phosphate, tocopherol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, dehydroxanthan gum, triethoxycaprylylsilane, polysorbate 60, sorbitan isostearate, sodium citrate, caprylhydroxamic acid, phytic acid, hydroxypropyl cyclodextrin, aminomethyl propanediol, citric acid, phenoxyethanol, chlorphenesin, potassium sorbate, sodium benzoate.
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.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Arbonne AgeWell Moisture Restoring Broad Spectrum SPF 15 Sunscreen Zinc Oxide WATER ALKYL (C12-15) BENZOATE GLYCERIN ISONONYL ISONONANOATE STEARETH-21 MEDIUM-CHAIN TRIGLYCERIDES SQUALANE DIMETHICONE SORBITAN MONOOLEATE STEARETH-2 ALOE VERA LEAF CUCUMBER LAMINARIA DIGITATA LAVANDULA STOECHAS FLOWERING TOP APPLE NASTURTIUM OFFICINALE TRIFOLIUM PRATENSE FLOWER HIPPOPHAE RHAMNOIDES SEED OIL OLIVE OIL HYALURONATE SODIUM TETRAHEXYLDECYL ASCORBATE PALMITOYL LYSYLDIOXYMETHIONYLLYSINE POLYGLYCERYL-3 LAURATE GLUCONOLACTONE XANTHAN GUM CALCIUM GLUCONATE MAGNESIUM ASCORBYL PHOSPHATE TOCOPHEROL HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) DEHYDROXANTHAN GUM TRIETHOXYCAPRYLYLSILANE POLYSORBATE 60 SORBITAN ISOSTEARATE TRISODIUM CITRATE DIHYDRATE CAPRYLHYDROXAMIC ACID FYTIC ACID HYDROXYPROPYL BETADEX AMINOMETHYL PROPANEDIOL ANHYDROUS CITRIC ACID PHENOXYETHANOL CHLORPHENESIN POTASSIUM SORBATE SODIUM BENZOATE 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.PRINCIPAL DISPLAY PANEL - 50 g Jar Carton AgeWell 100% VEGAN – CRUELTY-FREE MOISTURE RESTORING CREAM WITH BROAD SPECTRUM SPF 15 SUNSCREEN All Skin Types Net wt. 1.7 oz. / 50 g Arbonne AgeWell Moisture Cream
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
Distributed by Arbonne International, LLC • Greenwood, IN 46143 USA
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.
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? 1-800-272-6663 Monday–Friday 6 a.m.–6 p.m. PST
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 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