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ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM Avobenzone, Homosalate, Octisalate 13.5 g/100mL; 4.5 g/100mL; 2.7 g/100mL Cream, 10 mL — NDC 84616-005-02 (Billing 84616-0005-02)

by SEORIN COMPANY Co., Ltd. · 10 mL in 1 TUBE

This is a package of 10 mL of ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM Avobenzone, Homosalate, Octisalate 13.5 g/100mL; 4.5 g/100mL; 2.7 g/100mL Cream from SEORIN COMPANY Co., Ltd., no longer marketed (first marketed Sep 2024), no longer in the FDA NDC Directory.

NDC 84616-0005-02
🏷️ FDA NDC (as labeled) 84616-005-02 billing pads the product segment with a zero
This package
Contains10 mL Pack sizes3 compare ↓
Product page 84616-0005-01 Also comes in: 2 tubes 84616-005-03 50 ml 84616-005-01
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 84616-005-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84616 labeler · 005 product · 02 package
Package marketed since
Dec 18, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8461600502 5
FDA record last changed
Aug 27, 2026
⚠️
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 Oct 2025. 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) 84616-005-02
Product NDC 84616-005
11-digit billing NDC 84616000502
UNII V06SV4M95S, 4X49Y0596W, G63QQF2NOX
Application # M020
SPL Set ID 4260e410-d2d5-71b4-e063-6294a90a05b8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Oct 2025)
Marketing start 2024-09-18
Route TOPICAL
Dosage form CREAM
Substance HOMOSALATE; OCTISALATE; AVOBENZONE
Why two NDCs? The FDA registers this code as 84616-005-02 — 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 → 84616-0005-02. 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.

Clinical

🧪 What is this product?

This is a topical sunscreen cream containing three UV-filtering agents: avobenzone, homosalate, and octisalate. These active ingredients are commonly used together in sunscreens to absorb ultraviolet (UV) radiation and help protect skin from sun exposure. The product is formulated as an OTC monograph sunscreen, meaning it follows established FDA rules for sunscreen products rather than being individually reviewed. This cream is intended for application to the skin as a broad-spectrum sunscreen with an SPF 45 rating.

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 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: 2 tubes 50 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
84616-0005-01 84616-005-01 Main listing 50 mL in 1 TUBE 2024-09-18 — Discontinued by firm
84616-0005-02 You're viewing this 10 mL in 1 TUBE 2024-12-18 — Discontinued by firm
84616-0005-03 84616-005-03 2 TUBE in 1 BOX / 60 mL in 1 TUBE 2024-12-20 — Discontinued by firm

Pack size FAQ

What quantity is in this package?
This package contains 10 mL — 10 ml in 1 tube.
How does this package differ from NDC 84616-0005-01?
Both are ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM Avobenzone, Homosalate, Octisalate 13.5 g/100mL; 4.5 g/100mL; 2.7 g/100mL Cream — the drug itself is identical. This page's package is the 10 mL one, while NDC 84616-0005-01 is the 50 ml package.
What NDC number is used to bill for this package of ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM Avobenzone, Homosalate, Octisalate 13.5 g/100mL; 4.5 g/100mL; 2.7 g/100mL Cream?
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
Round Lab Birch Juice Moisturizing Uvlock Sunscreen Spf45 Broad Spectrum 13.5 g/100mL; 4.5 g/100mL; 2.7 g/100mLthis 84616-0005-02 SEORIN 10 ml — — Discontinued —
Round Lab Birch Juice Moisturizing Uvlock Sunscreen Spf50 Broad Spectrum 13.5 g/100mL; 4.5 g/100mL; 2.7 g/100mL 84616-0007-01 SEORIN 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

🏛️
2024
On the market since
Sep 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

LabelerSEORIN COMPANY Co., Ltd.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84616
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio10 products on file

More NDCs from SEORIN COMPANY Co., Ltd. labeler code 84616

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
🎯 Indications and Usage 30 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 aging caused by the sun.

⏱️ Dosage and Administration 93 words ▾

Directions apply liberally and evenly 15 minutes before sun exposure. Sun protection measures. ​Spending time in the sun increases your risk of skin cancer and early 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 children under 6 months of age: Ask a doctor reapply at least every 2 hours. use a water-resistant sunscreen if swimming or sweating

⚠️ 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 8 words ▾

Actives Ingredients Avobenzone 2.7% Homosalate 13.5% Octisalate 4.5%

🧪 Inactive Ingredients 88 words ▾

Inactive ingredients Water, Butyloctyl Salicylate, Propanediol, Acrylates Copolymer, Butylene Glycol, Caprylyl Methicone, Polyglyceryl-3 Distearate, Benzotriazolyl Dodecyl P-Cresol, Niacinamide, Diethylhexyl 2,6-Naphthalate, Polymethylsisesquioxane, Glycerin, Calcium Aluminum Borosilicate, 1,2-Hexanediol, Poly C10-30 Alkyl Acrylate, Pentylene Glycol, Cetearyl Aloohol, Tromethamine, Methy propanediol, Glyceryl Stearate Citrate, Betula Platyphylla Japonica Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Ethylhexylglycerin, Artemisia Annua Extract, Anthemis Nobilis Flower Oil, Sodium Stearoyl Glutamate, Glyceryl Polymethacrylate, Triethoxycaprylylsilane, Pinus Sylvestris Leaf Oil, Sparassis Crispa Extract, Polyether-1, Allantoin, Di-propylene Glycol, Glyceryl Glucoside, Biosaccharide Gum-1, Tocopherol, Portulaca Oleracea Extract, Sodium Hyaluronate, Hyaluronic Acid, Ascorbic 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 ↗

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 2 other package presentations of this same product, including 2 tubes (84616-0005-03), 50 ml (84616-0005-01). 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?
SEORIN COMPANY 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.
← 84616-0004-01 · SEORIN 84616-0006-01 · SEORIN →
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.