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Zinc Oxide Perfecting Sunscreen 10 g/100g Cream, 74 g — NDC 84378-0100-74 package photo

Zinc Oxide Perfecting Sunscreen 10 g/100g Cream, 74 g

by Epicuren Discovery · 74 g in 1 TUBE (84378-100-74)
NDC 84378-0100-74
🏷️ FDA NDC (as labeled) 84378-100-74 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

⚠️
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

FDA NDC (as labeled) 84378-100-74
Product NDC 84378-100
11-digit billing NDC 84378010074
UNII SOI2LOH54Z
Application # M020
SPL Set ID 1a0228f9-bf3f-a1fe-e063-6294a90a3fb5
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-09
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 84378-100-74 — 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 → 84378-0100-74. 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.

🏭 Manufacturer & labeler

LabelerEpicuren Discovery
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84378
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio4 products on file
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.

🩺 Clinical

🧪 What is this product?

This is a topical cream sunscreen containing zinc oxide as its active ingredient. Zinc oxide is a mineral UV filter commonly used in sunscreen products to help reflect ultraviolet light away from the skin. This product is marketed as an over-the-counter sunscreen under the FDA's monograph rules for sunscreen ingredients, meaning it follows an established set of safety and effectiveness standards for the category rather than undergoing 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.

🧪 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 54JB35T06A
    A natural oil extracted from apricot pits, used as an emollient and lubricant in topical products. It helps soften the skin and improves the texture and spreadability of creams and lotions.
  • UNII 26I94X9A1K
    Bellis perennis flower is an extract from the common daisy plant. It's used in medicines as a natural flavoring agent and may help improve the taste or aroma of the product.
  • UNII Q95M2P1KJL
    A silicone-based ingredient that acts as a lubricant and glidant. It helps the tablet or capsule move smoothly through manufacturing equipment and improves powder flow during production.
  • 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 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII 3U9288P88T
    Asafoetida is a dried resin extracted from the root of a plant native to Asia. It is used in medicines as a flavor enhancer and to improve the taste of 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 HYE7O27HAO
    Glyceryl isostearate is a fatty substance derived from vegetable oils or animal fats. In medicines, it acts as an emulsifier to blend water and oil components together, and helps form a smooth texture in creams, ointments, and other topical products.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII 45TGG6IU6M
    A natural plant extract from hibiscus flowers used as a colorant and flavoring agent in medicines. It adds red or purple color and a tart taste to tablets, capsules, and liquid formulations.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 412ZHA4T4Y
    A plant-derived oil extracted from meadowfoam seeds. It acts as an emollient and skin-conditioning agent, helping soften and smooth the product texture while improving how it spreads on skin.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 2ZN8DWC0YF
    A flavoring agent derived from pear fruit or created synthetically to mimic pear taste. It's added to medicines to improve flavor and make them more palatable, especially in liquid formulations for children.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • 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 A94I086Q5E
    A plant-derived ingredient from radish seeds. It acts as a natural binder and thickener, helping hold the medicine's ingredients together and improve texture.
  • 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 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.

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

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.

💲 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.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
ATTITUDE Super leaves Lip Balm SPF 15 Watermelon 10 g/100g 61649-0927-02 9055-7588 2 tubes — — FDA listed —
Skinsuit Lip Spf 30 10 g/100g 46007-0205-11 Skin 3.2 g — — FDA listed —
Sun and Honey 10 g/100g 85432-0001-01 Amara 1 tube — — FDA listed —
ATTITUDE Sunly Lip Balm SPF 15 Unscented 10 g/100g 61649-0550-02 9055-7588 2 tubes — — FDA listed —
Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum Sunscreen 10 g/100g 61649-0068-01 Attitude 30 g — — FDA listed —
ATTITUDE Sunly Lip Balm SPF 15 Watermelon 10 g/100g 61649-0557-02 9055-7588 2 tubes — — FDA listed —
ATTITUDE Sunly Lip balm Unscented SPF 15 10 g/100g 61649-0093-02 9055-7588 1 tube — — FDA listed —
ATTITUDE Super Leaves Lip Balm SPF15 Unscented 10 g/100g 61649-0920-02 9055-7588 2 tubes — — FDA listed —
Attitude - Leaves Bar - Lip Balm - SPF 15 - Mango 10 g/100g 61649-0983-01 9055-7588 8.5 g — — FDA listed —
DAILY FACE SUNSCREEN Broad Spectrum SPF 30 10 g/100g 81781-0101-50 Lilyana 1 tube — — FDA listed —
ATTITUDE Super leaves Lip Balm SPF 15 Coconut 10 g/100g 61649-0923-02 9055-7588 2 tubes — — FDA listed —
Zinc Oxide Perfecting Sunscreen 10 g/100gthis 84378-0100-74 Epicuren 74 g — — FDA listed —
ATTITUDE Sunly Lip Balm SPF 15 Coconut 10 g/100g 61649-0553-02 9055-7588 2 tubes — — FDA listed —
ATTITUDE Sunly Lip Balm SPF 15 Pineapple 10 g/100g 61649-0555-02 9055-7588 2 tubes — — FDA listed —
ATTITUDE Super leaves Lip Balm SPF 15 Exotic 10 g/100g 61649-0925-02 9055-7588 2 tubes — — FDA listed —
OLP diaper Rash cream A and D 10 g/100g 80489-0444-01 OL 1 tube — — FDA listed —
Attitude - Lip Balm - SPF 15 - Coconut 10 g/100g 61649-0985-01 Attitude 8.5 g — — 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
84378-0100-74 You're viewing this 74 g in 1 TUBE (84378-100-74) 2025-06-09 Active

🧭 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 FDA registers it as 84378-100-74, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 84378-0100-74, written without dashes as 84378010074. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 84378-0100-74, the first segment (84378) is the labeler code FDA assigned to Epicuren Discovery; the middle segment (0100) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (74) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Epicuren Discovery. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Epicuren Discovery 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.

📄 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 3 words ▾

Indication and Use

⏱️ Dosage and Administration 3 words ▾

Dosage and Administration

⚠️ Warnings 2 words ▾

Other information

🧪 Active Ingredient 2 words ▾

Active Ingredients

🧪 Inactive Ingredients 2 words ▾

Inactive Ing

🎯 Purpose 2 words ▾

OTC Purpose

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84377-0489-00 · Blair 84378-0101-74 · Epicuren →
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.