FDA.reportPublic FDA data

PLUMSCREEN

Product NDC
80476-101
11-digit product format
804760101
Labeler code
80476
Product ID
80476-101_47d5defe-1b5d-7e14-e063-6294a90a4de8
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Le Prunier Farms, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-21
Substance
ZINC OXIDE
Active strength
4.7 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
PLUMSCREEN
Brand name suffix
SPF 31
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE4.7 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e20eb996-2b64-6bd0-e053-2a95a90a4f92Available on FDA.report

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80476-101PLUMSCREEN SPF 31 (ZINC OXIDE) CREAM [LE PRUNIER FARMS, INC.]3Current NDC, Legacy NDC, 5 package rows20240530_e20eb996-2b64-6bd0-e053-2a95a90a4f92.zip

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 151 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Activated Mineral Sunscreen TintedACTIVATED MINERAL SUNSCREEN TINTEDReve Skincare LLC312a32a7-d253-f10c-e063-6294a90a803a2025-12-04WarningsExact identifier
application number: M020
Everyday Humans Sunscreen Lip Balm Broad Spectrum SPF30LIP BALM SPF30Everyday Group Limted2d42034a-4ada-57cf-e063-6394a90a0b5f2025-12-04WarningsExact identifier
application number: M020
Ciele SPF 30 prime PROTECT Broad Spectrum SPF 30 SunscreenSUNSCREEN 30 MINERALLE COSMETICS INC3bb54b93-0ab2-2ecc-e063-6394a90acac32025-12-04WarningsExact identifier
application number: M020
Good Times SPF 50 SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEEVERYDAY GROUP LIMITEDf40c6c4a-47a2-5dfe-e053-2995a90a3df32025-12-04WarningsExact identifier
application number: M020
Sheer Guard Natural Mineral SunscreenZINC OXIDEEVERYDAY GROUP LIMITED3257719d-dcc6-7ac5-e063-6294a90aafcd2025-12-04WarningsExact identifier
application number: M020
Sun Glazed SPF 30 Sunscreen Glow OilAVOBENZONE, HOMOSALATE, OCTOCRYLENEEVERYDAY GROUP LIMITEDdba8075b-be36-4787-b23d-942d0e792aa82025-12-04WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 DeepZINC OXIDECrunchi, LLC.0dc478e0-9555-4ce6-b448-7d58e3a6bae02025-12-04WarningsExact identifier
application number: M020
Solbar Shield SPF40SOLBAR SHIELD SPF40Person and Coveybd3a9a94-fc87-4127-abf9-29e56ac9ce5d2025-12-04WarningsExact identifier
application number: M020
Solbar Thirty SPF 30SOLBAR THIRTY SPF30Person and Coveyab9ac056-61d9-43d5-a3db-2d487897cc692025-12-04WarningsExact identifier
application number: M020
Solbar Fifty SPF50SOLBAR FIFTY SPF50Person and Covey41fd3844-181c-4cb2-8379-f313104351ef2025-12-04WarningsExact identifier
application number: M020
Solbar Avo SPF35SOLBAR AVO SPF35Person and Coveybfe1e828-76d4-4db3-a8ba-b54b31baacad2025-12-04WarningsExact identifier
application number: M020
Banana Boat Sport Ultra Broad Spectrum SPF 50 Plus Sunscreen Lip BalmAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc7a3c03b-7fee-404c-e053-2a95a90a3a972025-12-04WarningsExact identifier
application number: M020
Poolside Bronze Service Instant bronzing lotion. SPF30HOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.4524129b-f8aa-171b-e063-6294a90aeebe2025-12-04WarningsExact identifier
application number: M020
Solbar Zinc SPF38SOLBAR ZINC SPF38Person and Coveyfac62a2f-92ee-4afd-9999-bc5011159e432025-12-04WarningsExact identifier
application number: M020
elf Sun Boss Gloss SPF 25 Sunscreen Pink Me GirlZINC OXIDEe.l.f. Cosmetics, Inc.6c316ce4-c2f6-4633-a789-e786d0f76abd2025-12-04WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen coconut SPF 15 Scented lip glossHOMOSALATE, OCTOCRYLENE, OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b5f2c-b61f-8915-e063-6294a90ac9112025-12-04WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen watermelon SPF 15 Scented lip glossHOMOSALATE , OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b6e12-1bf9-8093-e063-6394a90a9e742025-12-04WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Papaya SPF 15 Scented lip glossHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b6f22-5080-86ab-e063-6394a90a04162025-12-04WarningsExact identifier
application number: M020
Poolside Golden Hour SPF15 sunscreen lip oilHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b8393-1887-a660-e063-6394a90a4c2b2025-12-04WarningsExact identifier
application number: M020
Poolside Sun Daze Body Illuminator SPF 30 shimmer sunscreen gelHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b8dde-dd63-b585-e063-6394a90a35432025-12-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80476-101-02804760101022 mL in 1 PACKET (80476-101-02) 2 ml2024-01-04NoNoCurrent
80476-101-10804760101101 TUBE in 1 BOX (80476-101-10) / 10 mL in 1 TUBE1 tube2022-06-210000-00-00NoNoCurrent
80476-101-60804760101601 TUBE in 1 BOX (80476-101-60) / 60 mL in 1 TUBE1 tube2022-06-210000-00-00NoNoCurrent