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| Product NDC Code | 71888-104 | ||||
|---|---|---|---|---|---|
| Drug Name | Shield |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Bellus Medical, LLC | ||||
| 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.Zinc Oxide 21%
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.Helps prevent sunburn and photodamage caused by UVA/UVB exposure Higher SPF gives more sunburn protection If used as directed with other sun protection measures (see DIRECTIONS), decreases the risks of skin cancer and early skin aging caused by the sun
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Argania Spinosa Kernel Oil, Caprylic/ Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside,Cetearyl Olivate, Coco-Caprylate/- Caprate , Cocoglycerides, Coconut Alkanes , Copernicia Cerifera (Carnauba) Wax, Diethylhexanoate, Ethyl Macadamiate, Glycerin, Glyceryl Caprylate, Glyceryl Isostearate, Glyceryl Undecylenate, Iron Oxides, Lysolecithin, Neopentyl Glycol, p-Anisic acid, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-3 Stearate, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Propanediol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Chloride, Sorbitan Olivate, Tocopherol Linoleate / Oleate, Triethoxycaprylylsilane, Water (Aqua), 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.Evenly apply to skin before exposure to sun and as needed. • Children under 6 months, ask doctor. • Protect this product from excessive heat and direct sun.
Purpose
Information about the drug product’s indications for use.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Shield Zinc Oxide CETEARYL OLIVATE COCONUT ALKANES PROPANEDIOL TRIETHOXYCAPRYLYLSILANE TRICAPRYLIN CARNAUBA WAX ZINC OXIDE ZINC OXIDE XANTHAN GUM ARGAN OIL GLYCERYL ISOSTEARATE COCO-CAPRYLATE SODIUM CHLORIDE POTASSIUM CETYL PHOSPHATE WATER ETHYL MACADAMIATE GLYCERIN SORBITAN OLIVATE JOJOBA OIL
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.SF_30ml_Box_SHIELD_FINAL_v3_160321 JPEG_Page_1
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Updated to include dosage and administration information. No changes to use of the product, adding section.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Call 888.372.3982 Distributed by: Crown Aesthetics Dallas, TX 75244 All registered trademarks belong to Crown Aesthetics.
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.For external use only. Do not use on damaged or broken skin. Stop use and ask doctor if rash and irritation develops and lasts. Avoid contact with eyes if product gets into eyes rinse thoroughly with water. 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