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Attitude - Leaves Bar - Lip Balm - SPF 15 - Mango ZINC OXIDE 10 g/100g Stick, 8.5 g — NDC 61649-0983-01 package photo

Attitude - Leaves Bar - Lip Balm - SPF 15 - Mango ZINC OXIDE 10 g/100g Stick, 8.5 g

by 9055-7588 Qubec Inc. DBA Attitude · 8.5 g in 1 TUBE (61649-983-01)
NDC 61649-0983-01
🏷️ FDA NDC (as labeled) 61649-983-01 billing pads the product segment with a zero
This package
Contains8.5 g Pack sizes2 compare ↓
Also comes in: 8.5 g 61649-0983-02
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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) 61649-983-01
Product NDC 61649-983
11-digit billing NDC 61649098301
UNII SOI2LOH54Z
Application # M020
SPL Set ID 359a7ebf-46a6-4e99-b43c-f585e9bc08d9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-02-04
Route TOPICAL
Dosage form STICK
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 61649-983-01 — 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 → 61649-0983-01. 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

Labeler9055-7588 Qubec Inc. DBA Attitude
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code61649
First marketedFeb 2022
Product typeHuman Otc Drug
Portfolio7 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 lip balm stick applied topically to the lips that contains 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 formulated as an OTC monograph drug, meaning it is marketed under established FDA guidelines for sunscreen products rather than as an individually approved application. The stick form with SPF 15 rating is typical for lip protection products.

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.

🧪 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 JPF3YI7O34
    A natural oil derived from pine plants and other sources. It serves as a fragrance, flavor enhancer, and solvent in medicines, helping deliver active ingredients and improve taste or smell.
  • UNII V14F8G75P4
    A fragrant alcohol compound derived from plants or made synthetically. It's used as a flavor and aroma agent to improve the taste and smell of medicines.
  • UNII 4V59G5UW9X
    Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • UNII K8NU647RJ0
    Behenyl behenate is a waxy ester derived from behenic acid. It acts as a lubricant and glidant in tablets and capsules to reduce friction during manufacturing and improve powder flow.
  • UNII WL0328HX19
    A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
  • UNII D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • UNII 42DG15CHXV
    A natural plant wax derived from sunflower seeds. It serves as a lubricant and glidant to help powders flow smoothly during manufacturing and tablet formation.
  • UNII GI6FE1QMW6
    Hexyl hexanoate is a synthetic ester, an oily liquid made from combining hexanol and hexanoic acid. It functions as a flavoring agent and solvent in medicines, helping to mask unpleasant tastes and dissolve active ingredients.
  • 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 YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • UNII IJ67X351P9
    A natural plant extract from rosemary leaves used as a preservative to help prevent oils and fats in the medicine from spoiling or becoming rancid during storage.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII CHI530446X
    Vanillin is a natural or synthetic aromatic compound that gives vanilla flavor. It's used in medicines as a flavoring agent to mask bitter tastes and improve how the medicine tastes.

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

The official label also statescocos nucifera (coconut) oil, polyhydroxystearic acid, butyrospermum parkii (shea) butter, helianthus annuus (sunflower) seed oil, helianthus annuus (sunflower) seed wax, behenyl behenate, caprylic/capric triglyceride, ricinus communis (castor) seed oil, argania spinosa kernel oil, flavor, euphorbia cerifera (candelilla) wax, coco-caprylate/caprate, rosmarinus officinalis (rosemary) leaf extract, caprylic/capric triglyceride *flavour, vanillin, 3-hexenol, hexyl hexanoate, alpha pinene.

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.

💲 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.

🔁 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/100gthis 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/100g 61649-0985-01 Attitude 8.5 g — — 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
Feb 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61649-0983-01 You're viewing this 8.5 g in 1 TUBE (61649-983-01) 2022-08-01 Active
61649-0983-02 1 TUBE in 1 BOX (61649-983-02) / 8.5 g in 1 TUBE (61649-983-01) 2022-02-04 Active

Pack size FAQ

What quantity is in NDC 61649-0983-01?
NDC 61649-0983-01 contains 8.5 g — 8.5 g in 1 tube.
What is the difference between NDC 61649-0983-01 and NDC 61649-0983-02?
Both are Attitude - Leaves Bar - Lip Balm - SPF 15 - Mango ZINC OXIDE 10 g/100g Stick — the drug itself is identical. NDC 61649-0983-01 is the 8.5 g package, while NDC 61649-0983-02 is the 1 tube package.
What NDC number is used to bill for this package of Attitude - Leaves Bar - Lip Balm - SPF 15 - Mango ZINC OXIDE 10 g/100g Stick?
Bill NDC 61649-0983-01 — the 11-digit billing format is 61649098301. 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) ✓ 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 61649-983-01, 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: 61649-0983-01, written without dashes as 61649098301. 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 61649-0983-01, the first segment (61649) is the labeler code FDA assigned to 9055-7588 Qubec Inc. DBA Attitude; the middle segment (0983) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 9055-7588 Qubec Inc. DBA Attitude. 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 1 tube (61649-0983-02). 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?
9055-7588 Qubec Inc. DBA Attitude 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 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 aging caused by the sun.

⏱️ Dosage and Administration 25 words ▾

Directions Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply after eating or drinking. FOR EXTERNAL USE ONLY.

⚠️ Warnings 54 words ▾

Warnings For external use only. Do not use on damaged or broken skin. If rash occurs, stop use and ask a doctor. When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 7 words ▾

Other Information Store at temperatures below 90°F.

🧪 Active Ingredient 5 words ▾

Medicinal ingredient Zinc oxide (10%)

🧪 Inactive Ingredients 62 words ▾

Inactive or non-medicinal ingredients cocos nucifera (coconut) oil, polyhydroxystearic acid, butyrospermum parkii (shea) butter, helianthus annuus (sunflower) seed oil, helianthus annuus (sunflower) seed wax, behenyl behenate, caprylic/capric triglyceride, ricinus communis (castor) seed oil, argania spinosa kernel oil, flavor, euphorbia cerifera (candelilla) wax, coco-caprylate/caprate, rosmarinus officinalis (rosemary) leaf extract, caprylic/capric triglyceride *flavour , vanillin , 3-hexenol , hexyl hexanoate , alpha pinene .

🎯 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 ↗
← 61649-0927-02 · 9055-7588 61649-0985-01 · Attitude →
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.