Home › NDC Lookup › Ingredients › Zinc Oxide › 61649-0985-02
Attitude - Lip Balm - SPF 15 - Coconut Zinc oxide 10 g/100g Stick, 1 tube — NDC 61649-0985-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Attitude - Lip Balm - SPF 15 - Coconut Zinc oxide 10 g/100g Stick, 1 tube — NDC 61649-985-02 (Billing 61649-0985-02)

by Attitude DBA 9055-7588 Qubec Inc. · 1 TUBE in 1 BOX / 8.5 g in 1 TUBE

This is a package of 1 tube of Attitude - Lip Balm - SPF 15 - Coconut Zinc oxide 10 g/100g Stick from Attitude DBA 9055-7588 Qubec Inc., marketed since Feb 2024 and currently FDA-listed.

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 ↓
Product page 61649-0985-01 Also comes in: 8.5 g 61649-985-01
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 61649-985-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
61649 labeler · 985 product · 02 package
Package marketed since
Feb 15, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6164998502 9
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 ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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.

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.

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 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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
61649-0985-01 61649-985-01 Main listing 8.5 g in 1 TUBE 2022-08-01 — Active
61649-0985-02 You're viewing this 1 TUBE in 1 BOX / 8.5 g in 1 TUBE 2024-02-15 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 tube — 1 tube in 1 box / 8.5 g in 1 tube.
How does this package differ from NDC 61649-0985-01?
Both are Attitude - Lip Balm - SPF 15 - Coconut Zinc oxide 10 g/100g Stick — the drug itself is identical. This page's package is the 1 tube one, 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?
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
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.

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

LabelerAttitude DBA 9055-7588 Qubec Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code61649
First marketedFeb 2024
Product typeHuman Otc Drug
Portfolio6 products on file

More NDCs from Attitude DBA 9055-7588 Qubec Inc. labeler code 61649

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 4 words ▾

Uses Helps prevent sunburn.

⏱️ Dosage and Administration 90 words ▾

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 39 words ▾

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 18 words ▾

Other Information Store at temperatures < 90F and protect from direct sun. Avoid contact of packaging with water.

🧪 Active Ingredient 5 words ▾

Medicinal ingredient Zinc oxide (10%)

🧪 Inactive Ingredients 76 words ▾

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 2 words ▾

Purpose Sunscreen

📄 Do Not Use 6 words ▾

Do not use on broken skin.

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and consult 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.

📄 Questions or Comments 3 words ▾

Questions ? 1-855-509-7225

📄 Recent Major Changes 4 words ▾

Update of the directions

📄 Package Label / Principal Display Panel 44 words ▾

PRINCIPAL DISPLAY PANEL - 8.5 g Tube Carton ATTITUDE natural care SPF 15 coconut lip balm universal shade BROAD SPECTRUM SUNSCREEN SPF 15 UVA UVB + NON NANO SUNLY 8.5 g / 0.3 oz. NPN 80109103 Vegan EWG Verified Ocean Lovers Dermatologically tested 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 Attitude - Lip Balm - SPF 15 - Coconut (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Age at onset

Neonate5
Infant8
Child28
Adolescent5
Adult110
Elderly192

Reporter sex

1,941 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization988
Death204
Life-threatening116
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 114 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) — 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 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.
← 61649-0983-01 · 9055-7588 61657-0003-01 · White →
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.