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PLUMSCREEN SPF 31 ZINC OXIDE 4.7 g/100mL Cream — NDC 80476-0101-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

PLUMSCREEN SPF 31 ZINC OXIDE 4.7 g/100mL Cream — NDC 80476-101-60 (Billing 80476-0101-60)

by Le Prunier Farms, Inc. · 1 TUBE in 1 BOX / 60 mL in 1 TUBE

This is a package of PLUMSCREEN SPF 31 ZINC OXIDE 4.7 g/100mL Cream from Le Prunier Farms, Inc., marketed since Jun 2022 and currently FDA-listed.

NDC 80476-0101-60
🏷️ FDA NDC (as labeled) 80476-101-60 billing pads the product segment with a zero
This package
Contains60 mL in 1 tube Pack sizes3 compare ↓
Product page 80476-0101-02 Also comes in: 10 mL 80476-101-10 2 ml 80476-101-02
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 80476-101-60 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
80476 labeler · 101 product · 60 package
Package marketed since
Jun 21, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8047610160 0
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80476-101-60
Product NDC 80476-101
11-digit billing NDC 80476010160
UNII SOI2LOH54Z
Application # M020
SPL Set ID e20eb996-2b64-6bd0-e053-2a95a90a4f92
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-06-21
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 80476-101-60 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 80476-0101-60. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

🧪 What is this product?

Plumscreen SPF 31 is a topical cream sunscreen containing zinc oxide as its active ingredient. Zinc oxide functions as a broad-spectrum ultraviolet (UV) filter, commonly used in sunscreen products to help protect skin from UV radiation when applied to exposed areas. This product is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for sunscreen ingredients rather than through individual product review.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (3 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 mL 2 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
80476-0101-10 80476-101-10 1 TUBE in 1 BOX / 10 mL in 1 TUBE 2022-06-21 — Active
80476-0101-60 You're viewing this 1 TUBE in 1 BOX / 60 mL in 1 TUBE 2022-06-21 — Active
80476-0101-02 80476-101-02 Main listing 2 mL in 1 PACKET 2024-01-04 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 box / 60 ml in 1 tube.
What NDC number is used to bill for this package of PLUMSCREEN SPF 31 ZINC OXIDE 4.7 g/100mL Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Plumscreen Spf 31 4.7 g/100mLthis 80476-0101-60 Le 1 tube — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Jun 2022
📍
2026
Currently FDA-listed
4 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • UNII MI97BW74XZ
    A synthetic compound derived from coconut oil and glycerin. It acts as an emulsifier and solubilizer to help mix oil and water components, and improves how the medicine dissolves and spreads in the body.
  • UNII 58B69Q84JO
    A plant-derived emulsifier made from olive oil and fatty alcohols. It helps blend oil and water ingredients together and stabilizes the product's texture in creams, lotions, and similar formulations.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • UNII 535G2ABX9M
    Fucus vesiculosus is a brown seaweed that serves as a thickener, binder, and emulsifier in medicines. It helps create smooth texture and hold ingredients together in liquid and semi-solid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII KLB93D0YFI
    A natural liquid extract from plums, used as a flavoring agent and sweetener to improve taste and palatability of the medicine.
  • UNII 67EIU8N086
    Plum seed oil is a natural oil extracted from plum kernels. It's used in medicines as an emollient and solvent to help dissolve or carry active ingredients and improve how the product spreads or absorbs.
  • UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • UNII MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • UNII 5EHL50I4MY
    A sodium salt compound used as a chelating agent in medicines. It binds to metals and minerals to improve stability, prevent discoloration, and help the medication stay effective longer.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

17 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesWATER (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

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerLe Prunier Farms, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code80476
First marketedJun 2022
Product typeHuman Otc Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

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 42 words ▾

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.

⚠️ Warnings 35 words ▾

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

📦 Storage and Handling 14 words ▾

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

🧪 Active Ingredient 6 words ▾

ACTIVE INGREDIENTS ZINC OXIDE (NON-NANO) 4.7%

🧪 Inactive Ingredients 44 words ▾

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

🎯 Purpose 2 words ▾

PURPOSE SUNSCREEN

📄 Keep Out of Reach of Children 21 words ▾

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

📄 Questions or Comments 3 words ▾

QUESTIONS? VISIT WWW.LEPRUNIER.COM

📄 Package Label / Principal Display Panel 1 words ▾

0-UC_Plumscreen_SPF31

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Le Prunier Farms, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 tube (80476-0101-10), 2 ml (80476-0101-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Le Prunier Farms, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 80466-0131-16 · Vantage 80489-0001-01 · OL →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.