Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Mineral Sunscreen 8 g/100g Cream — NDC 84778-094-01 (Billing 84778-0094-01)
by Guangzhou Yixin Cross-border E-commerce Co., Ltd. · 1 BOTTLE in 1 BOX / 50 g in 1 BOTTLE
This is a package of Mineral Sunscreen 8 g/100g Cream from Guangzhou Yixin Cross-border E-commerce Co., Ltd., no longer marketed (first marketed Aug 2025), no longer in the FDA NDC Directory. It is this product's only package size.
NDC 84778-0094-01
🏷️ FDA NDC (as labeled)
84778-094-01
billing pads the product segment with a zero
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 84778-094-01 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 84778 labeler · 094 product · 01 package
- Package marketed since
- Aug 24, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 6974792119810
- FDA record last changed
- Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory.
FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
84778-094-01
Product NDC
84778-094
11-digit billing NDC
84778009401
UNII
15FIX9V2JP
UPC
6974792119810
Application #
M020
SPL Set ID
3f81215c-e929-02cc-e063-6394a90a1b2b
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
Discontinued
FDA listing status
Inactivated by FDA (certified through Dec 2026)
Marketing start
2025-08-24
Route
CUTANEOUS
Dosage form
CREAM
Substance
TITANIUM DIOXIDE
Why two NDCs?
The FDA registers this code as 84778-094-01 — 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 → 84778-0094-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
🧪 What is this product?
This is an over-the-counter sunscreen cream applied to the skin. It contains titanium dioxide, a mineral-based ultraviolet (UV) filter that is commonly used in sunscreen products to help reflect and scatter UV rays away from the skin surface. This product is marketed under the FDA's monograph rules for over-the-counter sunscreen drugs rather than as an individually approved application.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
💬 Questions about Mineral Sunscreen?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per g | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 7, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 84778-0094-01 You're viewing this Main listing | 1 BOTTLE in 1 BOX / 50 g in 1 BOTTLE | 2025-08-24 | — | Inactivated by FDA |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Mineral Sunscreen 8 g/100gthis 84778-0094-01 | Guangzhou | 1 bottle | — | — | Discontinued | — |
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2025
On the market since
Aug 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.
- FDA Orange Book · refreshed Oct 3, 2026
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 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 25X51I8RD4
Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
2 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesAqua,Cyclopentasiloxane,Propylene Glycol,Glycerin,Lauryl PEG-9 PolydimethylsiloxyethylDimethicone,Ethylhexyl Salicylate,Cyclohexasiloxane,lsohexadecane,Polymethylsilsesquioxane,Hydrogenated Polyisobutene,Propylene Glycol Dicaprylate/Dicaprate,lron Oxides,Cetyl PEG/PPG-10/1Dimethicone,Polyglyceryl-4 lsostearate,Magnesium Sulfate,Tocopherol,Phenoxyethanol,Gentiana ScabraExtract,Methylparaben,Aroma,Propylparaben
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerGuangzhou Yixin Cross-border E-commerce Co., Ltd.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84778
First marketedAug 2025
Product typeHuman Otc Drug
Portfolio29 products on file
More NDCs from Guangzhou Yixin Cross-border E-commerce Co., Ltd... labeler code 84778
- Esokalli Testosterone Booster Oral Dissolving Film 20 mg/100mg; 20 mg/100mg Film, Soluble NDC 84778-088-01
- Esokalli Testosterone Booster Oral Dissolving Film 30 mg/100mg; 10 mg/100mg Film, Soluble NDC 84778-089-01
- Esokalli Testosterone Booster Oral Dissolving Film 40 mg/100mg; 20 mg/100mg Film, Soluble NDC 84778-090-01
- Esokalli Testosterone Booster Oral Dissolving Film 20 mg/100mg; 20 mg/100mg Film, Soluble NDC 84778-091-01
- Esokalli Testosterone Booster Oral Dissolving Film 30 mg/100mg; 10 mg/100mg Film, Soluble NDC 84778-092-01
- Esokalli Testosterone Booster Oral Dissolving Film 40 mg/100mg; 20 mg/100mg Film, Soluble NDC 84778-093-01
- Toiletseatspray .1 g/30mL Liquid NDC 84778-096-01
- TOILETPAPERSPRAY .1 g/30mL Liquid NDC 84778-097-01
- Hand Sanitizer Refill 62 mL/100mL Lotion NDC 84778-098-01
- 5% Minoxidil HAIR GROWTH SPARY 5 g/100mL Liquid NDC 84778-099-01
- ESOKALLI Delay Performance Gel .1 g/100mL; 2 g/100mL Gel NDC 84778-103-01
- 5%MINOXIDILHAIRGROWTHSPRAY 5 g/100mL Liquid NDC 84778-105-01
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
🧪 Inactive Ingredients
🎯 Purpose
📄 Do Not Use
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses Helps prevent sunburn
⏱️ Dosage and Administration ▾
Dosage and administration Stop use and ask a doctor if- Redness develops.
⚠️ Warnings ▾
Warnings For external use only. When using this product: - Do not get into eyes. Rinse with water to remove. Stop use and ask a doctor if: - Rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
🧪 Inactive Ingredients ▾
Inactive ingredients Aqua,Cyclopentasiloxane,Propylene Glycol,Glycerin,Lauryl PEG-9 PolydimethylsiloxyethylDimethicone,Ethylhexyl Salicylate,Cyclohexasiloxane,lsohexadecane,Polymethylsilsesquioxane,Hydrogenated Polyisobutene,Propylene Glycol Dicaprylate/Dicaprate,lron Oxides,Cetyl PEG/PPG-10/1Dimethicone,Polyglyceryl-4 lsostearate,Magnesium Sulfate,Tocopherol,Phenoxyethanol,Gentiana ScabraExtract,Methylparaben,Aroma,Propylparaben
🎯 Purpose ▾
Purpose sunscreen
📄 Do Not Use ▾
Do not use if you: Do not use - On damaged or broken skin. - If you have known allergies to any ingredient in the product.
📄 When Using This Product ▾
When using this product you may experience: Do not get into eyes. Rinse with water to remove
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if: Stop use and ask a doctor if - Irritation or rash persists. - Redness develops.
📄 Keep Out of Reach of Children ▾
Contraindications Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL 1
No label section mentions that — try another word, or open the full label on DailyMed below.
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
No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Guangzhou Yixin Cross-border E-commerce Co., Ltd. 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.
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.