Attitude - Lip Balm - SPF 15 - Coconut Zinc oxide 10 g/100g Stick, 1 tube
by Attitude DBA 9055-7588 Qubec Inc. · 1 TUBE in 1 BOX (61649-985-02) / 8.5 g in 1 TUBE (61649-985-01)
NDC 61649-0985-02
🏷️ FDA NDC (as labeled)
61649-985-02
billing pads the product segment with a zero
This package
Contains1 tube
Pack sizes2 compare ↓
Also comes in:
8.5 g 61649-0985-01
OTC
On market
Non-controlled
🗂️ 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 →
⚠️
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 ↗
🆔 Identity & classification
FDA NDC (as labeled)
61649-985-02
Product NDC
61649-985
11-digit billing NDC
61649098502
UNII
SOI2LOH54Z
Application #
M020
SPL Set ID
068af2ec-a666-45bf-b0e0-89d1b93dedf1
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2024-02-15
Route
TOPICAL
Dosage form
STICK
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 61649-985-02 — 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 → 61649-0985-02. 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
LabelerAttitude DBA 9055-7588 Qubec Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code61649
First marketedFeb 2024
Product typeHuman Otc Drug
Portfolio6 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 lip balm stick containing zinc oxide as its active ingredient. Zinc oxide is commonly used in over-the-counter sunscreen products to help protect skin from ultraviolet (UV) radiation. This product is marketed as an OTC monograph drug, meaning it follows FDA's established safety and effectiveness standards for the sunscreen category rather than undergoing individual product review. The balm is intended for application to the lips to provide sun protection.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:
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.
💬 Questions about Zinc oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💲 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 system | Per each | Per 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:
8.5 g
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| ATTITUDE Super leaves Lip Balm SPF 15 Watermelon 10 g/100g 61649-0927-02 | 9055-7588 | 2 tubes | — | — | FDA listed | — |
| Skinsuit Lip Spf 30 10 g/100g 46007-0205-11 | Skin | 3.2 g | — | — | FDA listed | — |
| Sun and Honey 10 g/100g 85432-0001-01 | Amara | 1 tube | — | — | FDA listed | — |
| ATTITUDE Sunly Lip Balm SPF 15 Unscented 10 g/100g 61649-0550-02 | 9055-7588 | 2 tubes | — | — | FDA listed | — |
| Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum Sunscreen 10 g/100g 61649-0068-01 | Attitude | 30 g | — | — | FDA listed | — |
| ATTITUDE Sunly Lip Balm SPF 15 Watermelon 10 g/100g 61649-0557-02 | 9055-7588 | 2 tubes | — | — | FDA listed | — |
| ATTITUDE Sunly Lip balm Unscented SPF 15 10 g/100g 61649-0093-02 | 9055-7588 | 1 tube | — | — | FDA listed | — |
| ATTITUDE Super Leaves Lip Balm SPF15 Unscented 10 g/100g 61649-0920-02 | 9055-7588 | 2 tubes | — | — | FDA listed | — |
| Attitude - Leaves Bar - Lip Balm - SPF 15 - Mango 10 g/100g 61649-0983-01 | 9055-7588 | 8.5 g | — | — | FDA listed | — |
| DAILY FACE SUNSCREEN Broad Spectrum SPF 30 10 g/100g 81781-0101-50 | Lilyana | 1 tube | — | — | FDA listed | — |
| ATTITUDE Super leaves Lip Balm SPF 15 Coconut 10 g/100g 61649-0923-02 | 9055-7588 | 2 tubes | — | — | FDA listed | — |
| Zinc Oxide Perfecting Sunscreen 10 g/100g 84378-0100-74 | Epicuren | 74 g | — | — | FDA listed | — |
| ATTITUDE Sunly Lip Balm SPF 15 Coconut 10 g/100g 61649-0553-02 | 9055-7588 | 2 tubes | — | — | FDA listed | — |
| ATTITUDE Sunly Lip Balm SPF 15 Pineapple 10 g/100g 61649-0555-02 | 9055-7588 | 2 tubes | — | — | FDA listed | — |
| ATTITUDE Super leaves Lip Balm SPF 15 Exotic 10 g/100g 61649-0925-02 | 9055-7588 | 2 tubes | — | — | FDA listed | — |
| OLP diaper Rash cream A and D 10 g/100g 80489-0444-01 | OL | 1 tube | — | — | FDA listed | — |
| Attitude - Lip Balm - SPF 15 - Coconut 10 g/100gthis 61649-0985-02 | Attitude | 1 tube | — | — | 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.
🔬 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 Attitude - Lip Balm - SPF 15 - Coconut (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 37%
Female · 63%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 61649-0985-01 | 8.5 g in 1 TUBE (61649-985-01) | 2022-08-01 | Active |
| 61649-0985-02 You're viewing this | 1 TUBE in 1 BOX (61649-985-02) / 8.5 g in 1 TUBE (61649-985-01) | 2024-02-15 | Active |
Pack size FAQ
What quantity is in NDC 61649-0985-02?
NDC 61649-0985-02 contains 1 tube — 1 tube in 1 box / 8.5 g in 1 tube.
What is the difference between NDC 61649-0985-02 and NDC 61649-0985-01?
Both are Attitude - Lip Balm - SPF 15 - Coconut Zinc oxide 10 g/100g Stick — the drug itself is identical. NDC 61649-0985-02 is the 1 tube package, while NDC 61649-0985-01 is the 8.5 g package.
What NDC number is used to bill for this package of Attitude - Lip Balm - SPF 15 - Coconut Zinc oxide 10 g/100g Stick?
Bill NDC 61649-0985-02 — the 11-digit billing format is 61649098502. 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
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) | — 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 FDA registers it as 61649-985-02, 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: 61649-0985-02, written without dashes as 61649098502. 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 61649-0985-02, the first segment (61649) is the labeler code FDA assigned to Attitude DBA 9055-7588 Qubec Inc.; the middle segment (0985) 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.
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 Attitude DBA 9055-7588 Qubec Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 8.5 g (61649-0985-01). 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?
Attitude DBA 9055-7588 Qubec Inc. 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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses Helps prevent sunburn.
⏱️ Dosage and Administration ▾
Directions Adults and children older than 6 months. Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours, after eating or drinking.
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 SPFvalue of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm; and wear long-sleeved shirts, pants, hats and sunglasses. Use a water resistant sunscreen if swimming or sweating.
⚠️ Warnings ▾
Warnings For external use only. Do not use on broken skin. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and consult a doctor if rash occurs.
📦 Storage and Handling ▾
Other Information Store at temperatures < 90F and protect from direct sun. Avoid contact of packaging with water.
🧪 Active Ingredient ▾
Medicinal ingredient Zinc oxide (10%)
🧪 Inactive Ingredients ▾
Inactive or non-medicinal ingredients Cocos Nucifera (Coconut) Oil, Polyhydroxystearic Acid, Caprylic/Capric Triglyceride, Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Ricinus Communis (Castor) Seed Oil, Argania Spinosa (Argan) Kernel Oil, Glyceryl Behenate, Euphorbia Cerifera (Candelilla) Wax, Octyldodecanol, CI 77491 (Iron Oxides), CI 77492 (Iron Oxides), CI 77742 (Manganese Violet), CI 77499 (Iron Oxides), Jojoba Esters, Trihydroxystearin, Stearoyl Glutamic Acid, Ethyl Acetate*, Ethyl Hexanoate*, Gamma-Nonalactone*, Gamma-Octalactone*, Vanillin*, *flavour (Aroma).
🎯 Purpose ▾
Purpose Sunscreen
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.