FDA.reportPublic FDA data

PLUMSCREEN

Manufacturer
Le Prunier Farms, Inc.
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:31:52

Label at a glance#

ProductPLUMSCREEN SPF 31
Active ingredientZINC OXIDE
Label structure10 sections

Indications and 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

Dosage and administration

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.

Storage and handling

TO BEST MAINTAIN FORMULA, STORE AWAY FROM EXCESSIVE HEAT AND DIRECT SUN.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE (NON-NANO) 4.7%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • 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 SECTION

  • KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL ATTENTION OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • TO BEST MAINTAIN FORMULA, STORE AWAY FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0-UC_Plumscreen_SPF310-UC_Plumscreen_SPF31

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80476-101-02PLUMSCREENSPF 312 mL in 1 PACKETCREAM24
80476-101-10PLUMSCREENSPF 3110 mL in 1 TUBECREAM104
80476-101-10PLUMSCREENSPF 311 in 1 BOXCREAM14
80476-101-60PLUMSCREENSPF 311 in 1 BOXCREAM14
80476-101-60PLUMSCREENSPF 3160 mL in 1 TUBECREAM604

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80476-10180476-101-10, 80476-101-60, 80476-101-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PLUM JUICEKLB93D0YFIIACT
WATER059QF0KO0RIACT
PLUM SEED OIL67EIU8N086IACT
SORBITAN OLIVATEMDL271E3GRIACT
CETEARYL OLIVATE58B69Q84JOIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
FUCUS VESICULOSUS535G2ABX9MIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCERYL ETHERMI97BW74XZIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PLUMSCREEN SPF 31ZINC OXIDELe Prunier Farms, Inc.e20eb996-2b64-6bd0-e053-2a95a90a4f922026-01-07WarningsExact identifier
ndc (package): 80476-101-10
ndc (package): 80476-101-02
ndc (package): 80476-101-60
ndc (product): 80476-101
ndc11 (package): 80476010110
ndc11 (package): 80476010160
ndc11 (package): 80476010102
spl id: 47d5defe-1b5d-7e14-e063-6294a90a4de8
spl set id: e20eb996-2b64-6bd0-e053-2a95a90a4f92

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.