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MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 ZINC OXIDE 240 mg/mL Lotion, 500 mL — NDC 64768-2924-02 package photo

MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 ZINC OXIDE 240 mg/mL Lotion, 500 mL

by Expanscience Laboratories d/b/a Mustela · 500 mL in 1 BOTTLE, PUMP (64768-2924-2)
NDC 64768-2924-02
🏷️ FDA NDC (as labeled) 64768-2924-2 billing pads the package segment with a zero
This package
Contains500 mL Pack sizes3 compare ↓
Also comes in: 100 ml 64768-2924-01 325 ml 64768-2924-03
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. 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

FDA NDC (as labeled) 64768-2924-2
Product NDC 64768-2924
11-digit billing NDC 64768292402
UNII SOI2LOH54Z
Application # M020
SPL Set ID 95ea5442-a7ca-0c7d-e053-2a95a90ad247
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2019-11-01
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 64768-2924-2 — 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 → 64768-2924-02. 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

LabelerExpanscience Laboratories d/b/a Mustela
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code64768
First marketedNov 2019
Product typeHuman Otc Drug
Portfolio7 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 lotion sunscreen containing zinc oxide as its active ingredient. Zinc oxide is a mineral UV filter commonly used in broad-spectrum sunscreens to help block ultraviolet radiation from reaching the skin. This product is marketed as an over-the-counter sunscreen under FDA's monograph rules for sun protection products. The lotion form is applied to the skin for sun protection purposes.

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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII N9PR3490H9
    A naturally derived form of vitamin E that acts as an antioxidant in medicines. It prevents oils and fats in the product from breaking down or becoming rancid during storage.
  • UNII TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII V5RS026Q0H
    A synthetic polymer made by combining several plastic-like compounds. It forms a protective coating on tablets or capsules to control where and when the medicine dissolves in the digestive system.
  • UNII CI87N1IM01
    A mixture of liquid hydrocarbons derived from petroleum, used as a lubricant and glidant to help the medicine flow smoothly during manufacturing and ensure even tablet coating or capsule filling.
  • 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 ANA2NCS6V1
    A natural oil derived from macadamia nuts, used as an emollient and conditioning agent. It helps soften the product's texture and improve how it spreads or absorbs on skin or mucous membranes.
  • 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 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 G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII 25G622K2RA
    A silicone-based surfactant that helps blend oil and water in cosmetic or topical formulations. It reduces surface tension to improve product spreadability and texture.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII 817L1N4CKP
    Malic acid is a naturally occurring organic acid found in fruits. It works as a buffer and flavor agent to maintain the medicine's pH balance and add tartness to the product.
  • 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 MZQ63P0N0W
    A plant-derived emulsifier made from glycerin and castor oil. It helps mix oil and water ingredients together in formulations like creams and lotions, keeping them blended.
  • 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII PN88NW0KPK
    A synthetic polymer made from citric acid and long-chain alcohols. It acts as a thickener and stabilizer in creams and lotions, helping maintain consistent texture and prevent ingredient separation.
  • UNII LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • 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.

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

The official label also statesWATER, C15-19 ALKANE, GLYCERIN, POLYGLYCERYL-3 POLYRICINOLEATE, ETHYL MACADAMIATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, STYRENE/ACRYLATES COPOLYMER, STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PROPANEDIOL, POLYHYDROXYSTEARIC ACID, TRIETHOXYCAPRYLYLSILANE, 1,2-HEXANEDIOL, HYDROXYACETOPHENONE, MAGNESIUM SULFATE, SODIUM CHLORIDE, CAPRYLHYDROXAMIC ACID, TOCOPHERYL ACETATE, SODIUM HYALURONATE, TOCOPHEROL, MALIC ACID

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 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: 100 ml 325 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mustela Mineral Sunscreen Broad Spectrum Spf 50 240 mg/mLthis 64768-2924-02 Expanscience 500 ml — — Discontinued —
Plexus Sun Shield Hydrating Mineral Sunscreen SPF 30 240 mg/mL 85532-0157-01 Plexus 1 tube — — FDA listed —
House of Colour Tinted Sunscreen SPF 50 240 mg/mL 85242-0000-00 House 50 ml — — 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

🏛️
2019
On the market since
Nov 2019
📍
2026
Currently FDA-listed
7 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.

🔬 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 ZINC OXIDE, TITANIUM DIOXIDE — the ingredient across all brands.

Top reported reactions

Chemical Burn1
Condition Aggravated1
Dehydration1
Erythema1
Erythema Of Eyelid1
Eyelid Irritation1
Eyelid Oedema1

Reporter sex

3 reports
Female · 100%
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 NDCDescription Marketing startStatus
64768-2924-01 100 mL in 1 TUBE (64768-2924-1) 2019-11-01 Active
64768-2924-02 You're viewing this 500 mL in 1 BOTTLE, PUMP (64768-2924-2) 2020-07-23 Discontinued by firm
64768-2924-03 325 mL in 1 BOTTLE, PUMP (64768-2924-3) 2022-03-07 Discontinued by firm

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 64768-2924-02?
NDC 64768-2924-02 contains 500 mL — 500 ml in 1 bottle, pump.
What is the difference between NDC 64768-2924-02 and NDC 64768-2924-01?
Both are MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 ZINC OXIDE 240 mg/mL Lotion — the drug itself is identical. NDC 64768-2924-02 is the 500 mL package, while NDC 64768-2924-01 is the 100 ml package.
What NDC number is used to bill for this package of MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 ZINC OXIDE 240 mg/mL Lotion?
Bill NDC 64768-2924-02 — the 11-digit billing format is 64768292402. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 64768-2924-2, 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: 64768-2924-02, written without dashes as 64768292402. 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 64768-2924-02, the first segment (64768) is the labeler code FDA assigned to Expanscience Laboratories d/b/a Mustela; the middle segment (2924) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 100 ml (64768-2924-01), 325 ml (64768-2924-03). 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?
Expanscience Laboratories d/b/a Mustela 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 30 words ▾

Uses Helps prevent sunburn If used as directed wtih other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

⏱️ Dosage and Administration 95 words ▾

Directions Apply liberally to exposed areas 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating. immediately after towel drying. at least every 2 hours. 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 of 15 or higher and other sun protection measures including: limit time in the sun, expecially from 10 a.m. - 2 p.m. wear long-sleeved shirt, pants, hat and sunglasses children under 6 months: ask a doctor

⚠️ Warnings 56 words ▾

Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of the 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.

🧪 Active Ingredient 5 words ▾

Active Ingredient Zinc Oxide 24%

🧪 Inactive Ingredients 40 words ▾

Inactive ingredients WATER, C15-19 ALKANE, GLYCERIN, POLYGLYCERYL-3 POLYRICINOLEATE, ETHYL MACADAMIATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, STYRENE/ACRYLATES COPOLYMER, STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PROPANEDIOL, POLYHYDROXYSTEARIC ACID, TRIETHOXYCAPRYLYLSILANE, 1,2-HEXANEDIOL, HYDROXYACETOPHENONE, MAGNESIUM SULFATE, SODIUM CHLORIDE, CAPRYLHYDROXAMIC ACID, TOCOPHERYL ACETATE, SODIUM HYALURONATE, TOCOPHEROL, MALIC ACID

🎯 Purpose 2 words ▾

Purpose Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 64768-2922-01 · Expanscience 64768-2926-01 · Expanscience →
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.