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Plumscreen spf 31 - Medication Information

Product NDC Code 80476-101
Drug Name

Plumscreen spf 31

Type Brand
Active Ingredients
Zinc oxide 4.7 g/100ml
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name Le Prunier Farms, Inc.
Packages
Package NDC Code Description
80476-101-02 2 ml in 1 packet (80476-101-02)
80476-101-10 1 tube in 1 box (80476-101-10) / 10 ml in 1 tube
80476-101-60 1 tube in 1 box (80476-101-60) / 60 ml in 1 tube
Check if available Online

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