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 320 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alba Botanica Sport SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Inc.fd78fb8e-99b0-91b0-e053-6394a90a92712023-11-16WarningsExact identifier
application number: M020
Alba Botanica Kids SPF 50 Tropical FruitAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Incf6941bab-1e97-1dc8-e053-2995a90a93172023-11-16WarningsExact identifier
application number: M020
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDERite Aid0a4cea12-7e00-d201-e063-6394a90a66912023-11-16WarningsExact identifier
application number: M020
SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATECLINIQUE LABORATORIES LLCfb841fd7-0c78-01a1-e053-6394a90a43822023-11-15WarningsExact identifier
application number: M020
Banana Boat Kids Sport Sunscreen Roll-On UVA/UVB Broad Spectrum SPF 60 PlusAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc7563a84-f622-dad6-e053-2a95a90aa8d92023-11-15WarningsExact identifier
application number: M020
Rite Aid Ryshi Facial Mist Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid0a3808e5-3f94-0544-e063-6294a90a823b2023-11-15WarningsExact identifier
application number: M020
HEB Solutions Sunscreen Face 50 Facial Mist SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf6cdeb2f-fc58-1780-e053-6394a90a544a2023-11-15WarningsExact identifier
application number: M020
Rite Aid Ryshi Sunscreen with Hyaluronic Acid and Collagen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid0a3933b3-171f-8ce1-e063-6294a90a2d352023-11-15WarningsExact identifier
application number: M020
Rite Aid Ryshi Sunscreen Face Primer Shea Butter, Aloe, Mineral Oil, and Vitamin E Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid0a39957a-798d-b0a9-e063-6294a90a135d2023-11-15WarningsExact identifier
application number: M020
Rite Aid Mineral Sensitive Skin Zinc Oxide Sunscreen For Face SPF 50ZINC OXIDERite Aid0a39c146-a7a0-cde6-e063-6294a90a16a72023-11-15WarningsExact identifier
application number: M020
Beach Gypsy SPF-30OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEMJ Products Association, LLCa518e048-5614-4b67-b6fa-e1f2e380f3522023-11-15WarningsExact identifier
application number: M020
Sea Star Sparkle SPF-50 MANGO-TANGOOCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMJ Products Association, LLC1f4ea582-c4d5-4c0a-8fea-4eeb2fbb63272023-11-15WarningsExact identifier
application number: M020
Max MineralTITANIUM DIOXIDE, ZINC OXIDEPeter Thomas Roth Labs, LLC0980992c-6488-2fa1-e063-6294a90a41ea2023-11-14WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum LLCf1d46728-6933-4e6f-b7c0-3613466aa1f02023-11-14WarningsExact identifier
application number: M020
SIGNATURE CARE ACNE TREATMENTSALICYLIC ACIDSAFEWAY, INC.a60134d0-f788-90e8-e053-2a95a90acbde2023-11-14WarningsExact identifier
application number: M020
Curology the sunscreen broad spectrum SPF 30ZINC OXIDECurology Inc.e441895a-83b6-1cd5-e053-2995a90aab4b2023-11-14WarningsExact identifier
application number: M020
In Transit Skin DefenceAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONETHIS WORKS PRODUCTS LIMITEDc3425525-df4d-403b-ac7a-84067f0301182023-11-14WarningsExact identifier
application number: M020
Perfect Legs Skin Protector SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENETHIS WORKS PRODUCTS LIMITEDe0c54af2-9ea4-4dec-9d48-1048839508182023-11-14WarningsExact identifier
application number: M020
Suzanne Organics Tinted Mineral Sunscreen Broad Spectrum SPF 25 - SandZINC OXIDESLC Skincare935d0f47-048d-4823-bf08-8ece23e697362023-11-14WarningsExact identifier
application number: M020
Suzanne Organics Tinted Mineral Sunscreen Broad Spectrum SPF 25 - BronzeZINC OXIDESLC Skincaredefbb664-0a94-4ea6-b036-71782880151e2023-11-14WarningsExact 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