Sheer Tint Mineral SPF Serum - Light Light zinc oxide 220 ug/g Liquid, 1 bottle
by Mineral Fusion brands · 1 BOTTLE, DROPPER in 1 CARTON (55789-2501-4) / 29.5735 g in 1 BOTTLE, DROPPER (55789-2501-1)
NDC 55789-2501-04
🏷️ FDA NDC (as labeled)
55789-2501-4
billing pads the package 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 →
⚠️
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)
55789-2501-4
Product NDC
55789-2501
11-digit billing NDC
55789250104
UNII
SOI2LOH54Z
Application #
M020
SPL Set ID
ac6fdc35-82f8-4805-875e-2aa91aedec6f
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2025-02-07
Route
TOPICAL
Dosage form
LIQUID
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 55789-2501-4 — a 5-4-1 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 package segment → 55789-2501-04. 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
LabelerMineral Fusion brands
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code55789
First marketedFeb 2025
Product typeHuman Otc Drug
Portfolio3 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?
Sheer Tint Mineral SPF Serum is a liquid sunscreen product applied to the skin. It contains zinc oxide, a mineral ingredient commonly used in sunscreens to reflect and scatter ultraviolet (UV) rays from the sun. This is an over-the-counter monograph drug, meaning it is marketed under the FDA's established rules for sunscreen products rather than as an individually approved application.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:
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.
💬 Questions about zinc oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
Brown
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 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.
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UNII 105S6I733Z
A natural oil extracted from chamomile and other plants. It acts as a fragrance and flavoring agent to improve the taste and smell of the medicine.
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UNII A9EJ3J61HQ
A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
-
UNII ZY81Z83H0X
Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
-
UNII 2EH13UN8D3
A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
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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.
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UNII 609A3V1SUA
A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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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.
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UNII TM2TZD4G4A
A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
-
UNII UDR641JW8W
A plant-derived oil from jojoba seeds that has been broken down into smaller components. It acts as an emollient and skin-conditioning agent to help soften and smooth the product's texture.
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UNII 724GKU717M
Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
-
UNII 981F40Q9FF
A synthetic oil derived from isostearic acid, used as an emollient and lubricant in topical formulations. It helps soften the skin and improves the spreadability and texture of creams and lotions.
-
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.
-
UNII 88496G1ERL
Sodium phytate is a plant-derived salt used in medications as a chelating agent and preservative. It helps stabilize formulations and may improve how the body absorbs certain minerals in the medicine.
-
UNII 90TF85HH91
A fatty substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water-based ingredients together in the medicine, and may also help with texture and consistency.
-
UNII 9229XJ4V12
A synthetic emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients in formulations, keeping them mixed and preventing separation.
-
UNII 687U3PEB2Y
A complex emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients together and improves the texture and stability of creams, lotions, and other formulated products.
-
UNII YPM0ZOC2HR
A synthetic emulsifier derived from glycerin and castor oil. It helps mix oil and water-based ingredients together in the formulation to create a uniform product and improve texture.
-
UNII C2BRV53B1V
A plant-derived oil from pongamia seeds used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product texture while improving how it spreads on skin.
-
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 EU2PSP0G0W
Silica dimethyl silylate is a silicon-based powder that acts as a glidant and anti-caking agent. It reduces friction between particles and helps powders flow smoothly during manufacturing and tablet compression.
-
UNII 0W8RRI5W5A
A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.
-
UNII 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
-
UNII 24SC3U704I
A powdery carbohydrate extracted from tapioca plant roots. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your digestive system.
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UNII R0ZB2556P8
Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
-
UNII AZQ08K38Z1
A synthetic oily liquid derived from salicylic acid. It works as an emollient and penetration enhancer in topical formulations, helping active ingredients absorb into skin while conditioning and softening the application area.
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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.
27 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesWater/Aqua/Eau, Tridecyl Salicylate, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Propanediol, Jojoba Esters, Methylheptyl Isostearate, Polyglyceryl-10 Stearate, Aloe Barbadensis (Aloe Vera) Leaf Juice Certified Organic Ingredient, Polyglyceryl-4-Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-2 Dipolyhydroxystearate, Soy Lecithin, Sorbitan Sesquioleate, Tapioca Starch, Niacinamide, Pongamia Pinnata Seed Extract, Tocopherol (Vitamin E), Bisabolol, Glycerin, Caprylhydroxamic Acid, Glyceryl Caprylate, Polyglyceryl-6 Polyricinoleate, Simmondsia Chinensis (Jojoba) Seed Oil, Silica, Sodium Phytate, Iron Oxides (CI 77491, CI 77492, CI 77499).
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.
💲 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 mL | 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sheer Tint Mineral SPF Serum - Light Light 220 ug/gthis 55789-2501-04 | Mineral | 1 bottle | — | — | 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
Feb 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.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Sheer Tint Mineral SPF Serum - Light Light (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 37%
Female · 63%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 55789-2501-04 You're viewing this | 1 BOTTLE, DROPPER in 1 CARTON (55789-2501-4) / 29.5735 g in 1 BOTTLE, DROPPER (55789-2501-1) | 2025-02-07 | 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 55789-2501-4, 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: 55789-2501-04, written without dashes as 55789250104. 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 55789-2501-04, the first segment (55789) is the labeler code FDA assigned to Mineral Fusion brands; the middle segment (2501) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Mineral Fusion brands. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Mineral Fusion brands 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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
⏱️ Dosage and Administration ▾
Directions Apply liberally and evenly 15 minutes before sun exposure Reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours Children under 6 months of age: Ask a doctor Sun Protection Measures ; Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m.-2 p.m.
Wear long-sleeved shirts, pants, hats and sunglasses.
⚠️ Warnings ▾
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. Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other Information Protect the product in this container from excessive heat and direct sun.
🧪 Active Ingredient ▾
Active Ingredients Zinc Oxide 22%
🧪 Inactive Ingredients ▾
Inactive Ingredients: Water/Aqua/Eau, Tridecyl Salicylate, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Propanediol, Jojoba Esters, Methylheptyl Isostearate, Polyglyceryl-10 Stearate, Aloe Barbadensis (Aloe Vera) Leaf Juice Certified Organic Ingredient , Polyglyceryl-4-Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-2 Dipolyhydroxystearate, Soy Lecithin, Sorbitan Sesquioleate, Tapioca Starch, Niacinamide, Pongamia Pinnata Seed Extract, Tocopherol (Vitamin E), Bisabolol, Glycerin, Caprylhydroxamic Acid, Glyceryl Caprylate, Polyglyceryl-6 Polyricinoleate, Simmondsia Chinensis (Jojoba) Seed Oil, Silica, Sodium Phytate, Iron Oxides (CI 77491, CI 77492, CI 77499).
🎯 Purpose ▾
Purpose Sunscreen
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 ↗
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.