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| Product NDC Code | 69435-1412 | ||||
|---|---|---|---|---|---|
| Drug Name | Fre protect body ultra-light gel cream spf 50 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | JELLY | ||||
| Application Number | M020 | ||||
| Labeler Name | Peer Pharm Ltd. | ||||
| 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 ingredients Zinc Oxide 24%
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.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Coco-Caprylate/Caprate, Dicaprylyl Ether, Glycerin, Propanediol, Polyglyceryl-6 Stearate, Silica, Polyhydroxystearic Acid, Vitis Vinifera (Grape) Seed Oil, Rosa Canina Fruit Extract, Niacinamide, Butyrospermum Parkii (Shea) Butter, Simmondsia Chinensis (Jojoba) Seed Oil, Triethoxycaprylylsilane, Cetyl Alcohol, Xanthan Gum, Caprylyl Glycol, Glyceryl Stearate, Argania Spinosa Kernel (Argan) Oil, Panthenol, Ascorbyl Tetraisopalmitate, Lecithin, Sclerotium Gum, Pullulan, Polyglyceryl-6 Behenate, Caprylhydroxamic Acid, Tocopherol, Pongamia Pinnata Seed Extract, Pongamol, Argania Spinosa Leaf Extract, Argania Spinosa Callus Culture Extract, Isomalt, Cananga Odorata Flower (Ylang-Ylang) Oil.
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.Directions • Apply liberally 15 minutes before sun exposure. • Reapply: • After 80 minutes of swimming or sweating. • Immediately after towel drying. • At least every 2 hours. • 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. • Limit time in the sun, especially from 10 a.m.-2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses. • For children under 6 months of age: Ask a doctor.
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.FRE PROTECT BODY Ultra-Light Gel Cream SPF 50 ZINC OXIDE WATER COCO-CAPRYLATE/CAPRATE DICAPRYLYL ETHER GLYCERIN PROPANEDIOL POLYGLYCERYL-6 STEARATE SILICA POLYHYDROXYSTEARIC ACID (2300 MW) GRAPE SEED OIL ROSA CANINA FRUIT NIACINAMIDE SHEA BUTTER JOJOBA OIL TRIETHOXYCAPRYLYLSILANE CETYL ALCOHOL XANTHAN GUM ZINC OXIDE ZINC OXIDE CAPRYLYL GLYCOL GLYCERYL STEARATE PANTHENOL ARGAN OIL ASCORBYL TETRAISOPALMITATE LECITHIN, SOYBEAN SCLEROTIUM GUM PULLULAN POLYGLYCERYL-6 BEHENATE CAPRYLHYDROXAMIC ACID TOCOPHEROL PONGAMIA PINNATA SEED PONGAMOL ARGANIA SPINOSA LEAF ISOMALT YLANG-YLANG 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.PROTECT BODY SPF 50
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.Questions & Comments? Call toll free 1-888-589-6243
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Other information Protect this product in this container from excessive heat and direct sun. • Do not use if the seal is broken.
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 Keep out of reach of children
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