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| Product NDC Code | 62742-4115 | ||||
|---|---|---|---|---|---|
| Drug Name | Broad spectrum spf 35 eco |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part352 | ||||
| Labeler Name | Allure Labs Inc | ||||
| 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 - 18.9%
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: Apply liberally 15 minutes before sun exposure. Reapply: after swimming or sweating. Immediately after towel drying. At least every 2 hours.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingrediaents: Caprylic/Capric Triglyceride, Water (Aqua), Glycerin, Polysorbate 60, Stearic Acid, Cetyl Alcohol, Sorbitan Stearate, Cetearyl Glucoside, Stearyl Alcohol, Polyhydroxystearic Acid, Polyglyceryl-3 Ricinoleate, Isostearic Acid, Lecithin, Xanthan Gum, Carageenan, Helionori, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Tocopherol, Ethylhexylglycerin.
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.Broad Spectrum SPF 35 ECO Zinc Oxide WATER POLYHYDROXYSTEARIC ACID STEARATE ASCORBYL PALMITATE ISOSTEARIC ACID LECITHIN, SOYBEAN ALOE VERA LEAF ETHYLHEXYLGLYCERIN STEARYL ALCOHOL ZINC OXIDE ZINC OXIDE GLYCERIN POLYSORBATE 60 SORBITAN MONOSTEARATE CETEARYL GLUCOSIDE TOCOPHEROL CARRAGEENAN PORPHYRA UMBILICALIS POLYGLYCERYL-3 RICINOLEATE MEDIUM-CHAIN TRIGLYCERIDES STEARIC ACID CETYL ALCOHOL XANTHAN GUM
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.Sun Research LLC Santa Cruz, CA www.burnoutsun.com Image Broad Spectrum SPF 35 ECO
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Children under 6 months: Ask a doctor.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.High sun protection product.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Call toll free 1-800-798-7970
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. Stop and ask a doctor if rash or irritation occurs.
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.
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