Active Ingredients
ZINC OXIDE (NON-NANO) 4.7%
Plumscreen Cream
FDA Label NDC 80476-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Le Prunier Farms, Inc. for the product Plumscreen (NDC 80476-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
SUNSCREEN
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
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
Otc - Keep Out Of Reach Of Children
- KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL ATTENTION OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
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.
Other Information
- TO BEST MAINTAIN FORMULA, STORE AWAY FROM EXCESSIVE HEAT AND DIRECT SUN.
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
Questions?
VISIT WWW.LEPRUNIER.COM
Package Label.Principal Display Panel
0-uc_plumscreen_spf31 (0 Uc Plumscreen Spf31)
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