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| Product NDC Code | 80476-101 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Plumscreen spf 31 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Le Prunier Farms, 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 INGREDIENTS ZINC OXIDE (NON-NANO) 4.7%
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 BEFORE EXPOSURE TO ALL SKIN EXPOSED TO THE SUN. REAPPLY AT LEAST EVERY 2 HOURS. USE A WATERPROOF SUNSCREEN IF SWIMMING OR SWEATING CONSULT YOUR DOCTOR BEFORE APPLYING ON CHILDREN UNDER 6 MONTHS OF AGE.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS WATER (AQUA), COCO-CAPRYLATE/CAPRATE, PRUNUS DOMESTICA SEED OIL, PRUNUS DOMESTICA EXTRACT, HYDROLYZED PRUNUS DOMESTICA FRUIT EXTRACT, GLYCERIN, CETEARYL ALCOHOL, CETEARYL OLIVATE, SORBITAN OLIVATE, PROPANEDIOL, ZONARIA TOURNEFORTII EXTRACT, SODIUM STEAROYL GLUTAMATE, SILICA, XANTHAN GUM, TETRASODIUM GLUTAMATE DIACETATE, POLYHYDROXYSTEARIC ACID, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCERYL ETHER
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), THIS PRODUCT REDUCES 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.PLUMSCREEN SPF 31 ZINC OXIDE COCO-CAPRYLATE/CAPRATE GLYCERIN PROPANEDIOL CETOSTEARYL ALCOHOL POLYHYDROXYSTEARIC ACID (2300 MW) PLUM JUICE WATER PLUM SEED OIL SORBITAN OLIVATE CETEARYL OLIVATE TETRASODIUM GLUTAMATE DIACETATE FUCUS VESICULOSUS SILICON DIOXIDE CAPRYLHYDROXAMIC ACID CAPRYLYL GLYCERYL ETHER SODIUM STEAROYL GLUTAMATE XANTHAN GUM 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.0-UC_Plumscreen_SPF31
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 PRODUCT IS SWALLOWED, GET MEDICAL ATTENTION 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? VISIT WWW.LEPRUNIER.COM
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION TO BEST MAINTAIN FORMULA, STORE AWAY 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
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