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Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15 HOMOSALATE, OCTINOXATE 44.5 mg/mL; 34.5 mg/mL Cream — NDC 74690-0030-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15 HOMOSALATE, OCTINOXATE 44.5 mg/mL; 34.5 mg/mL Cream — NDC 74690-030-00 (Billing 74690-0030-00)

by FARMASI US LLC · 1 BOTTLE in 1 BOX / 15 mL in 1 BOTTLE

This is a package of Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15 HOMOSALATE, OCTINOXATE 44.5 mg/mL; 34.5 mg/mL Cream from FARMASI US LLC, marketed since Jan 2022 and currently FDA-listed. It is this product's only package size.

NDC 74690-0030-00
🏷️ FDA NDC (as labeled) 74690-030-00 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 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 74690-030-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
74690 labeler · 030 product · 00 package
Package marketed since
Jan 5, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7469003000 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 74690-030-00
Product NDC 74690-030
11-digit billing NDC 74690003000
UNII V06SV4M95S, 4Y5P7MUD51
Application # M020
SPL Set ID 1dbd5e83-2248-4751-88d9-b446ccc3c61e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-01-05
Route TOPICAL
Dosage form CREAM
Substance HOMOSALATE; OCTINOXATE
Why two NDCs? The FDA registers this code as 74690-030-00 — 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 → 74690-0030-00. 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 an over-the-counter lip balm cream containing two UV-filtering ingredients, homosalate and octinoxate. These chemical compounds are commonly used in sunscreen products to absorb ultraviolet light and help protect the skin from sun exposure. The product is formulated with an SPF 15 rating, which indicates the level of UV protection provided. This lip balm is applied topically to the lips and is marketed as an OTC monograph drug, meaning it follows FDA's established safety and effectiveness standards for sunscreen products in this category.

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.
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
74690-0030-00 You're viewing this Main listing 1 BOTTLE in 1 BOX / 15 mL in 1 BOTTLE 2022-01-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dr C Tuna Sun protector lip balm SPF 15 44.5 mg/mL; 34.5 mg/mL 74690-0020-00 Farmasi 1 bottle — — FDA listed —
Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15 44.5 mg/mL; 34.5 mg/mLthis 74690-0030-00 FARMASI 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

🏛️
2022
On the market since
Jan 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.

💡 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 Q1LS2UJO3A
    Ceresin is a purified mineral wax derived from ozocerite. It functions as a binding agent, thickener, and coating material in medicines to help hold ingredients together and provide texture or protective coating.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII A1CB3Z898P
    A synthetic oily compound made from plant-derived fatty acids and fumaric acid. It acts as a solubilizer and emulsifier to help dissolve and stabilize active ingredients in the medicine.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 08MNR5YE2R
    A wax made in a laboratory to mimic natural beeswax. It's used as a coating, binder, and thickener to give medicines a smooth texture and protect them from moisture.

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

The official label also statesPolyisoprene, C18-70 Isoalkane, Caprylic/Capric Triglyceride, Olus Oil, Synthetic Beeswax, Ceresin, Cetyl Alcohol, Di-C12-15 Alkyl Fumarate, Butyrospermum Parkii Butter, Silica, Aroma/Flavour, Tocopheryl Acetate.

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.

Manufacturer & labeler

LabelerFARMASI US LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code74690
First marketedJan 2022
Product typeHuman Otc Drug
Portfolio31 products on file

More NDCs from FARMASI US LLC labeler code 74690

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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 4 words ▾

Uses: Helps prevent sunburn.

⏱️ Dosage and Administration 68 words ▾

Directions: Apply liberally 15 minutes before sun exposure - reapply at least every two hours. Apply morning and night, and as often as needed during the day. Reapply frequently on sun-centric days, and adventures. Children under 6 months of age: Ask a doctor. Apply before sun exposure. To maintain protection, apply frequently, especially after sweating, swimming or drying off. Apply sufficient amount to the skin. Sun Protection Measures:

⚠️ Warnings 135 words ▾

Warnings: For external use only. Do not use on damaged or broken skin. undefined 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.

This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Protects against UVB and UVA rays. This product does not provide 100% protection.

Use physical protection (hat, t-shirt, glasses, etc.) Avoid long periods of sun exposure even if you are using sun protection. Keep babies and young children out of direct sunlight. The excessive sun exposure is a major health risk, Discontinue use if signs of irritation or rash occur.

Aovid contact with eyes, may cause irritation.

🧪 Active Ingredient 11 words ▾

Active Ingredients: Homosalate 4,45 % Ethylhexyl Methoxycinnamate 3,45 % Purpose: Sunscreen

🧪 Inactive Ingredients 24 words ▾

Inactive Ingredients: Polyisoprene, C18-70 Isoalkane, Caprylic/Capric Triglyceride, Olus Oil, Synthetic Beeswax, Ceresin, Cetyl Alcohol, Di-C12-15 Alkyl Fumarate, Butyrospermum Parkii Butter, Silica, Aroma/Flavour, Tocopheryl Acetate.

🎯 Purpose 2 words ▾

Purpose: Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin.

📄 When Using This Product 10 words ▾

undefined 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 103 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Protects against UVB and UVA rays. This product does not provide 100% protection. Use physical protection (hat, t-shirt, glasses, etc.) Avoid long periods of sun exposure even if you are using sun protection.

Keep babies and young children out of direct sunlight. The excessive sun exposure is a major health risk, Discontinue use if signs of irritation or rash occur. Aovid contact with eyes, may cause irritation.

📄 Questions or Comments 14 words ▾

Questions or Comments? [email protected] (833) 432-7627 Monday - Friday (9 a.m. -9 p.m. EST)

📄 Package Label / Principal Display Panel 13 words ▾

Package Labeling: Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15, 15ml/0.5fl.oz Label01

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 HOMOSALATE, OCTINOXATE — the ingredient across all brands.

Top reported reactions

Rash13
Acne10
Sunburn9
Dry Skin8
Erythema8
Malignant Melanoma8
Swelling Face8

Age at onset

Child1
Adult9
Elderly11

Reporter sex

143 reports
Male · 34%
Female · 66%

Serious outcomes

Hospitalization22
Death6
Disabling3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 14 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
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 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 FARMASI US LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
FARMASI US LLC 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.
← 74690-0028-00 · Farmasi 74690-0040-00 · Farmasi →
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.