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| Product NDC Code | 82086-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Maui island secret browning creme broad spectrum spf 5 sunscreen |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part352 | ||||
| Labeler Name | Formula 7venz L.L.C. | ||||
| 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 ingredient Zinc Oxide 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 • Apply liberally and evenly 15 minutes prior to sun exposure • Reapply: After 40 minutes of swimming or sweating · immediately after towel drying · at least every 2 hours • Children under 6 months of age: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe barbadensis leaf juice, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, beeswax, helianthus annuus (sunflower) seed oil, ricinus communis (castor) seed oil, glycerin, sorbitan sesquioleate, cetyl alcohol, stearyl alcohol, polyhydroxystearic acid, coffea arabica (coffee) seed oil, camellia sinensis leaf extract, ilex paraguariensis leaf extract, rosa canina fruit oil, carthamus tinctorius (safflower) seed oil, rubus idaeus (raspberry) fruit extract, squalane, magnesium aluminum silicate, xanthan gum, propanediol, ethylhexylglycerin, potassium sorbate, fragrance, caramel.
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.
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.Maui Island Secret Browning Creme Broad Spectrum SPF 5 Sunscreen Zinc Oxide ZINC OXIDE ZINC CATION ALOE VERA LEAF ALKYL (C12-15) BENZOATE MEDIUM-CHAIN TRIGLYCERIDES GLYCERYL MONOSTEARATE YELLOW WAX SUNFLOWER OIL CASTOR OIL GLYCERIN SORBITAN SESQUIOLEATE CETYL ALCOHOL STEARYL ALCOHOL POLYHYDROXYSTEARIC ACID (2300 MW) ARABICA COFFEE OIL GREEN TEA LEAF ILEX PARAGUARIENSIS LEAF ROSA CANINA FRUIT OIL SAFFLOWER OIL RASPBERRY SQUALANE MAGNESIUM ALUMINUM SILICATE XANTHAN GUM PROPANEDIOL ETHYLHEXYLGLYCERIN POTASSIUM SORBATE CARAMEL
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.Packaging IMAGE
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
The Original Made with Aloe, Coffee Seed Oil, Rose Hips and Green Tea. • Reef Safe • Never Tested on Animals • Distributed by: Formula 7venz, LLC. 118 Kupuohi Street Suite C-4 Lahaina, HI 96761 www.MauiIslandSecret.com
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 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? Call us! (702) 275-6167
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 Skin cancer/skin aging alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. 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 doctor if rash occurs. Keep out of reach of children . If swallowed, get medical help or contact 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