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 80 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NELLY DEVUYST BIOSOLAR COLORLIFT 3 TINTED SUNSCREEN SPF30ZINC OXIDELABORATOIRES DRUIDE INC19af4441-31b2-72db-e063-6394a90a813c2026-01-14WarningsExact identifier
application number: M020
Sqween Paint-On Sun Protection for Independent Kids Mineral Sunscreen SPF 30ZINC OXIDESqween LLC9c3cf35b-4bde-46e3-8abd-5f4d1ad6e4862026-01-14WarningsExact identifier
application number: M020
SCENTUAL AROMA BEAUTY SUN VEIL SPF30TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES DRUIDE INC0799ac38-9a41-6579-e063-6394a90ac4b62026-01-14WarningsExact identifier
application number: M020
NUDA CANADA SOLARGLOW MINERAL SERUM SUNSCREEN SPF30ZINC OXIDELABORATOIRES DRUIDE INC0b412e24-baf6-e68e-e063-6394a90a5f492026-01-14WarningsExact identifier
application number: M020
Dr. C. Tuna Sun Stick SPF 50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETIfc89d1b5-1ffe-4f06-8c5c-31f2eb0b56412026-01-14WarningsExact identifier
application number: M020
Oiana Mineral Sunscreen DropsZINC OXIDEOiana LLC4860257d-a8bf-7ce5-e063-6394a90a74db2026-01-14WarningsExact identifier
application number: M020
Standard Procedure Lip Balm SPF 50ZINC OXIDE HOMOSALATE OCTOCRYLENEStandard Procedure Inc1e3db995-b1c5-3a2e-e063-6294a90af75e2026-01-14WarningsExact identifier
application number: M020
Standard Procedure SPF 50 SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEStandard Procedure Inc1d3f87de-90c0-75c0-e063-6394a90a2ef42026-01-14WarningsExact identifier
application number: M020
EELHOE Bio Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.48654406-505b-518b-e063-6394a90a5add2026-01-14WarningsExact identifier
application number: M020
JAYSUING Hyaluronic Acid Moisturizing SunscreenTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.48662fae-2d41-4a4a-e063-6394a90a15222026-01-14WarningsExact identifier
application number: M020
CALIFORNIA ALOE FRESH POW DERY SUNHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANENATURE REPUBLIC CO., LTD.aa10dbbf-97b3-4258-bbd3-0d8cc9935e122026-01-13WarningsExact identifier
application number: M020
COSRXVITAMIN E VITALIZING SUNSCREENCOSRX inc.4840f608-944a-3e3d-e063-6394a90a1d9d2026-01-13WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCb043f0f3-b263-4c49-86ca-9ecc71a22aa82026-01-13WarningsExact identifier
application number: M020
ARAMORE MULTI-DEFENSE SUNSCREEN - AM Broad Spectrum SPF 30ZINC OXIDENew Frontier Bio, Incef6c8443-fd10-2022-e053-2a95a90a45ea2026-01-13WarningsExact identifier
application number: M020
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC2e5315bf-39f4-401c-8207-18ef6a97e0242026-01-13WarningsExact identifier
application number: M020
Intellishade TruPhysical SPF 45TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe20f5dc9-e863-b090-e053-2a95a90a50442026-01-13WarningsExact identifier
application number: M020
Intellishade TruPhysical Clear SPF 50TITANIUM DIOXIDE, ZINC OXIDERevision, LLC1305fa94-47d5-7a42-e063-6394a90a0aba2026-01-13WarningsExact identifier
application number: M020
Intellishade Clear SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATERevision, LLCe213b46d-d061-dc83-e053-2995a90ad8752026-01-13WarningsExact identifier
application number: M020
Intellishade Matte SPF 45OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe213ae87-4db2-3070-e053-2995a90a083b2026-01-13WarningsExact identifier
application number: M020
Sun Project MoistureHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANETHANK YOU FARMER CO., LTD20a83f02-d851-4aac-e063-6394a90ae1a62026-01-13WarningsExact 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