Home › NDC Lookup › Ingredients › Titanium Dioxide Zinc Oxide › 85679-0219-30
💊image loading
(from DailyMed)

Non-Tinted Sports Stick Titanium Dioxide, Zinc Oxide 55 mg/g; 40 mg/g Stick, 30 g — NDC 85679-219-30 (Billing 85679-0219-30)

by HELTON SKIN & LASER INSTITUTE · 30 g in 1 CYLINDER

This is a package of 30 g of Non-Tinted Sports Stick Titanium Dioxide, Zinc Oxide 55 mg/g; 40 mg/g Stick from HELTON SKIN & LASER INSTITUTE, marketed since Feb 2024 and currently FDA-listed. It is this product's only package size.

NDC 85679-0219-30
🏷️ FDA NDC (as labeled) 85679-219-30 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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 85679-219-30 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
85679 labeler · 219 product · 30 package
Package marketed since
Feb 22, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8567921930 5
FDA record last changed
Aug 27, 2026
⚠️
Other active recalls for Titanium Dioxide, Zinc Oxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 3, 2024 — Microbial Contamination of Non-Sterile Product (Vivier Pharma, Inc.) · FDA recall D-0662-2024
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) 85679-219-30
Product NDC 85679-219
11-digit billing NDC 85679021930
UNII SOI2LOH54Z, 15FIX9V2JP
Application # M020
SPL Set ID 35aa833a-19a1-99e9-e063-6394a90a840f
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-02-22
Route TOPICAL
Dosage form STICK
Substance ZINC OXIDE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 85679-219-30 — 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 → 85679-0219-30. 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?

This is a topical sunscreen stick containing titanium dioxide and zinc oxide, two mineral UV filters commonly used in over-the-counter sunscreen products. These ingredients function as physical blockers that reflect and scatter ultraviolet radiation away from the skin. The product is marketed as an OTC monograph drug, meaning it follows the FDA's established rule-book for sunscreen ingredients rather than being individually reviewed. The stick form makes it convenient for targeted application to areas like the face, nose, and ears.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 eachPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
85679-0219-30 You're viewing this Main listing 30 g in 1 CYLINDER 2024-02-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mineral Based Sunscreen Stick Tinted 55 mg/g; 40 mg/g 81679-0220-30 KATHLEEN 30 g — — FDA listed —
Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85413-0212-45 HALEM 1 cylinder — — FDA listed —
Flash Invisible Stick 55 mg/g; 40 mg/g 85497-0219-30 AEON 30 g — — FDA listed —
Sun Plus Sun Lip Shield 55 mg/g; 40 mg/g 85599-0212-45 CLEAN 1 cylinder — — FDA listed —
Mineral Lip Sunscreen Tinted 55 mg/g; 40 mg/g 85634-0212-45 DR. 1 cylinder — — FDA listed —
Sheer Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85317-0212-45 TRU 4.5 g — — FDA listed —
Advanced Lip Guard 55 mg/g; 40 mg/g 85351-0212-45 ADVANCED 4.5 g — — FDA listed —
Sunshade Mineral Stick Sunscreen 55 mg/g; 40 mg/g 85730-0219-30 BELLAGENA 30 g — — FDA listed —
CoTZ Kids Mineral Sun Stick 55 mg/g; 40 mg/g 58892-0362-30 Fallien 1 cylinder — — FDA listed —
Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85581-0212-45 Helen's 1 cylinder — — FDA listed —
Tinted Lip Sunscreen 55 mg/g; 40 mg/g 85327-0212-45 Rhonda 1 cylinder — — FDA listed —
Lip Balm 55 mg/g; 40 mg/g 85649-0212-45 PATRICIA 1 cylinder — — FDA listed —
Lip Crack 55 mg/g; 40 mg/g 85730-0212-45 BELLAGENA 1 cylinder — — FDA listed —
Kind Restore Moisturizing Lip Balm 55 mg/g; 40 mg/g 85895-0212-45 POLISH 1 cylinder — — FDA listed —
Really Great Lip Shield 55 mg/g; 40 mg/g 85585-0212-45 JEFFREY 1 cylinder — — FDA listed —
Mineral Lip Protection 55 mg/g; 40 mg/g 85504-0212-45 COLETTE 1 cylinder — — FDA listed —
Mineral Stick Tinted 55 mg/g; 40 mg/g 85507-0220-30 IT 30 g — — FDA listed —
Mineral Lip Protection 55 mg/g; 40 mg/g 85563-0212-45 CLEAR 4.5 g — — FDA listed —
Tinted Lip Sunscreen 55 mg/g; 40 mg/g 85608-0212-45 LA 1 cylinder — — FDA listed —
Lip Protection 55 mg/g; 40 mg/g 85339-0212-45 Teton 1 cylinder — — FDA listed —
Mineral Stick Non-Tinted 55 mg/g; 40 mg/g 85507-0219-30 IT 30 g — — FDA listed —
Lip Protecting 55 mg/g; 40 mg/g 85531-0212-45 JOHANNA'S 4.5 g — — FDA listed —
Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85558-0212-45 LOTUS 1 cylinder — — FDA listed —
Tinted Lip Sunscreen 55 mg/g; 40 mg/g 85596-0212-45 LAURA 1 cylinder — — FDA listed —
Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85625-0212-45 LUNDQUIST 1 cylinder — — FDA listed —
Non-Tinted Sports Stick 55 mg/g; 40 mg/gthis 85679-0219-30 HELTON 30 g — — FDA listed —
Tinted Lip Shade Sunscreen 55 mg/g; 40 mg/g 85712-0212-45 BLISS 1 cylinder — — FDA listed —
Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85888-0212-45 MILESTHETICS 1 cylinder — — FDA listed —
Mineral Sunscreen Stick Non-Tinted 55 mg/g; 40 mg/g 87572-0219-30 UNDRBUDR, 30 g — — FDA listed —
Non Tinted Mineral Sunscreen Stick 55 mg/g; 40 mg/g 85374-0219-30 BABYFACE 30 g — — FDA listed —
Tinted Mineral Sunscreen Stick 55 mg/g; 40 mg/g 85414-0220-30 Hirschman, 30 g — — FDA listed —
Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85492-0212-14 The 1 cylinder — — FDA listed —
Tinted Mineral Sunscreen Stick 55 mg/g; 40 mg/g 85598-0220-30 BASS 30 g — — FDA listed —
Mineral Tinted Lip Sunscreen 55 mg/g; 40 mg/g 85620-0212-45 JADEIA 4.5 g — — FDA listed —
Non Tinted Mineral Sunscreen Stick 55 mg/g; 40 mg/g 85888-0219-30 MILESTHETICS 30 g — — FDA listed —
Mineral Sunscreen Stick - Tinted 55 mg/g; 40 mg/g 87572-0220-30 UNDRBUDR, 30 g — — FDA listed —
Mineral Based Sunscreen Stick Non-Tinted 55 mg/g; 40 mg/g 81679-0219-30 KATHLEEN 30 g — — FDA listed —
Sunscreen Plus Mineral Stick Tinted 55 mg/g; 40 mg/g 85329-0220-30 Lily 30 g — — FDA listed —
Sun Safe Lip Balm 55 mg/g; 40 mg/g 85628-0212-45 REVIVE 1 cylinder — — FDA listed —
Tinted Lip Protection 55 mg/g; 40 mg/g 85747-0212-45 WECARE 1 cylinder — — FDA listed —
Tinted Mineral Sunscreen Stick 55 mg/g; 40 mg/g 85888-0220-30 MILESTHETICS 30 g — — FDA listed —
Tinted Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85939-0212-45 ORAIOS 1 cylinder — — FDA listed —
PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreen 55 mg/g; 40 mg/g 58892-0212-45 Fallien 4.5 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

🏛️
2024
On the market since
Feb 2024
📍
2026
Currently FDA-listed
2 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerHELTON SKIN & LASER INSTITUTE
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code85679
First marketedFeb 2024
Product typeHuman Otc Drug
Portfolio3 products on file

More NDCs from HELTON SKIN & LASER INSTITUTE labeler code 85679

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.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel 2 words ▾

Package Label

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

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 Titanium Dioxide, Zinc Oxide — the ingredient across all brands.

Top reported reactions

Exposure To Toxic Agent7
Product Contamination Chemical5
Acute Myeloid Leukaemia4
Malignant Melanoma4
Neoplasm Malignant4
Sunburn4
Application Site Rash3

Age at onset

Child1
Adolescent1
Adult7
Elderly2

Reporter sex

44 reports
Male · 24%
Female · 76%

Serious outcomes

Hospitalization7
Death2
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 11 1
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.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 HELTON SKIN & LASER INSTITUTE. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
HELTON SKIN & LASER INSTITUTE 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.
← 85679-0208-50 · HELTON 85691-0203-50 · LEDUC, →
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.