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The Tinted Serum Broad Spectrum SPF 50 ZINC OXIDE 240 mg/mL Emulsion, 5 mL — NDC 83108-001-05 (Billing 83108-0001-05)

by Rationale Group Pty Ltd · 5 mL in 1 BOTTLE, DROPPER

This is a package of 5 mL of The Tinted Serum Broad Spectrum SPF 50 ZINC OXIDE 240 mg/mL Emulsion from Rationale Group Pty Ltd, no longer marketed (first marketed Nov 2022), no longer in the FDA NDC Directory, this package's marketing ended Sep 2026.

NDC 83108-0001-05
🏷️ FDA NDC (as labeled) 83108-001-05 billing pads the product segment with a zero
This package
Contains5 mL Pack sizes5 compare ↓
Product page 83108-0001-00 Also comes in: 30 mL 83108-001-00 3 ml 83108-001-03 3 ml 83108-001-13 5 ml 83108-001-15
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ 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 →

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 83108-001-05 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
83108 labeler · 001 product · 05 package
Package marketed since
Dec 8, 2022
Package marketing ended
Sep 1, 2026
Sample package
Yes — professional sample, not for sale
Barcode (UPC)
9359782001608
FDA record last changed
Jul 24, 2026
⚠️
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. The listing was last certified through Sep 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) 83108-001-05
Product NDC 83108-001
11-digit billing NDC 83108000105
UNII SOI2LOH54Z
UPC 9359782001608
Application # M020
SPL Set ID f8ffcbc0-0dd3-4fce-b38b-37d38d631b61
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2026)
Marketing start 2022-11-25
Marketing end 2026-09-01
Route TOPICAL
Dosage form EMULSION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 83108-001-05 — 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 → 83108-0001-05. 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 tinted emulsion (lotion) applied to the skin that contains zinc oxide, a mineral sunscreen ingredient. Zinc oxide is commonly used in sunscreen products to help protect skin from ultraviolet (UV) radiation by sitting on the skin's surface and reflecting UV rays away. This product is marketed as an over-the-counter sunscreen under FDA's OTC monograph rules, which means its formulation follows established category guidelines rather than individual FDA approval.

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.

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 mLPer 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: 30 mL 3 ml 3 ml 5 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
83108-0001-00 83108-001-00 Main listing 1 BOTTLE, DROPPER in 1 BOX / 30 mL in 1 BOTTLE, DROPPER 2022-11-25 Sep 1, 2026 Discontinued by firm
83108-0001-03 83108-001-03 3 mL in 1 BOTTLE, DROPPER Sample 2022-12-08 Sep 1, 2026 Discontinued by firm
83108-0001-05 You're viewing this 5 mL in 1 BOTTLE, DROPPER Sample 2022-12-08 Sep 1, 2026 Discontinued by firm
83108-0001-13 83108-001-13 3 mL in 1 BOTTLE Sample 2022-12-08 Sep 1, 2026 Discontinued by firm
83108-0001-15 83108-001-15 5 mL in 1 BOTTLE Sample 2022-12-08 Sep 1, 2026 Discontinued by firm

Pack size FAQ

What quantity is in this package?
This package contains 5 mL — 5 ml in 1 bottle, dropper.
How does this package differ from NDC 83108-0001-03?
Both are The Tinted Serum Broad Spectrum SPF 50 ZINC OXIDE 240 mg/mL Emulsion — the drug itself is identical. This page's package is the 5 mL one, while NDC 83108-0001-03 is the 3 ml package.
What NDC number is used to bill for this package of The Tinted Serum Broad Spectrum SPF 50 ZINC OXIDE 240 mg/mL Emulsion?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
The Tinted Serum Broad Spectrum SPF 50 240 mg/mLthis 83108-0001-05 Rationale 5 ml — — 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.

Availability & generic status

🏛️
2022
On the market since
Nov 2022
📍
2026
Currently FDA-listed
4 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

LabelerRationale Group Pty Ltd
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83108
First marketedNov 2022
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from Rationale Group Pty Ltd labeler code 83108

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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 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 31 words ▾

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

⏱️ Dosage and Administration 92 words ▾

Directions Apply liberally 15 minutes before sun exposure. Reapply At least every 2 hours Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin ageing. 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 -2p.m. Wear long sleeved shirts, pants, hats and sunglasses.

Children under 6 months of age: Ask a doctor.

⚠️ Warnings 54 words ▾

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.

🧪 Active Ingredient 7 words ▾

Active Ingredient Zinc Oxide 24% Purpose Sunscreen

🧪 Inactive Ingredients 209 words ▾

Inactive ingredients Trisiloxane, Isoamyl Laurate, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Cyclopentasiloxane, PEG-10 Dimethicone, Ethylhexyl Methoxycrylene, Lauryl PEG-10 Tris (Trimethylsiloxy) silylethyl Dimethicone, Aqua (Water), Styrene/Acrylates Copolymer, Triacontanyl PVP, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Pentaerhthrityl Tetraisostearate, Methyl Methacrylate Crosspolymer, Propanediol, Isostearic Acid, Glyceryl Caprylate, CI 77891 (Titanium Dioxide), Polyhydroxystearic Acid, Boron Nitride, 1,2-Hexanediol, Mica, Disteardimonium Hectorite, Glycerin, Sodium Chloride, CI 77492 (Iron Oxides), Bisabolol, Propylene Carbonate, Camellia Sinensis Leaf Extract, Hydrolyzed Keratin, Caprylhydroxamic Acid, Sodium Potassium Aluminum Silicate, Limonene, Citrus Aurantium Bergamia (Bergamot) Leaf Oil, Citrus Aurantium Dulcis (Orange) Oil, Juniperus Mexicana Oil, Pelargonium Graveolens Oil, 7-Dehydrocholesterol, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Maltodextrin, Silica, CI 77491 (Iron Oxides), Anigozanthos Flavidus Flower Extract, Syzygium Luehmannii Fruit Extract, Tin Oxide, Aspalathus Linearis Leaf Extract, Butylene Glycol, Sodium Lactate, Sodium PCA, Melanin, CI 77499 (Iron Oxides), Pentylene Glycol, Ceteareth-25, Linalool, Dimethicone, Magnesium Aspartate, Zinc Gluconate, Cetyl Alcohol, Citronellol, Sodium Hyaluronate, Davidsonia Pruriens Fruit Extract, Sodium Benzoate, Glycine, Ethylhexylglycerin, Potassium Sorbate, Behenic Acid, Ceramide NP, Cholesterol, Copper Gluconate, Fructose, Inositol, Lactic Acid, Niacinamide, Urea, Phenoxyethanol, Citric Acid, Ceramide NS, Serine, Glutamic Acid, Ceramide AP, Ceramide EOP, Ceramide EOS, Asparic Acid, Leucine, Acetyl Tetrapeptide-22, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Propine, Threonine, Valine, Isoleucine, Histidine

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 8 words ▾

Do not use On damaged or broken skin.

📄 When Using This Product 13 words ▾

When using this product Keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if Rash occurs.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 16 words ▾

Package Labeling: Label2

Package Labeling:3ml SFC1 3ml5mlC ml3 3mlNew 3ml5mlNew

Package Labeling:5ml SFC2 3ml5mlCombo ml5 5mlNew

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 ZINC OXIDE — the ingredient across all brands.

Top reported reactions

Macular Degeneration460
Nausea365
Pyrexia351
Pain348
Malaise289
Weight Decreased284
Constipation257

Age at onset

Neonate6
Infant11
Child35
Adolescent8
Adult218
Elderly272

Reporter sex

3,195 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization1,368
Death290
Life-threatening166
Disabling63
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 207 0
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 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 — 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.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 1 bottle (83108-0001-00), 3 ml (83108-0001-03), 3 ml (83108-0001-13). 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?
Rationale Group Pty 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.
← 83107-0031-01 · Legacy 83108-0100-00 · Rationale →
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.