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Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum Sunscreen ZINC OXIDE 10 g/100g Stick, 30 g — NDC 61649-0068-01 package photo

Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum Sunscreen ZINC OXIDE 10 g/100g Stick, 30 g

by Attitude DBA 9055-7588 Qubec Inc. · 30 g in 1 TUBE (61649-068-01)
NDC 61649-0068-01
🏷️ FDA NDC (as labeled) 61649-068-01 billing pads the product segment with a zero
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) 61649-068-01
Product NDC 61649-068
11-digit billing NDC 61649006801
UNII SOI2LOH54Z
Application # M020
SPL Set ID 9ed70230-980c-474c-9f72-a6be0f355124
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-01-25
Marketing end 2027-03-25
Route TOPICAL
Dosage form STICK
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 61649-068-01 — 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 → 61649-0068-01. 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

LabelerAttitude DBA 9055-7588 Qubec Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code61649
First marketedJan 2023
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 an over-the-counter sunscreen stick containing zinc oxide, marketed as an OTC monograph product under FDA rules for sunscreen category ingredients. Zinc oxide is a mineral UV filter that functions to help protect skin from ultraviolet radiation by reflecting and scattering UV rays away from the skin surface. The product is applied topically to exposed skin and is formulated with a broad-spectrum rating, meaning it is intended to filter both UVA and UVB radiation. This stick form is designed for convenient application to areas like the face and ears.

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 AU6XZE9IY9
    A natural wax derived from acacia decurrens flowers. It functions as a coating agent, lubricant, and polish to give tablets and capsules a smooth, protective finish and improve handling during manufacturing.
  • 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 43AGM4PHPI
    A mixture of plant or animal oils and fats with 10 to 18 carbon chains. Used as a solvent and carrier to dissolve or suspend active ingredients, helping deliver the medicine effectively.
  • 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 N7YC58165T
    A synthetic polymer made from glycerin and sebacic acid, used as a film-former and binder in medications. It helps hold tablet or capsule ingredients together and may coat the product for controlled release.
  • 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 8470G57WFM
    Corn oil is a vegetable oil extracted from corn kernels. It's used in medicines as a solvent to dissolve active ingredients and help the body absorb them, and sometimes as a lubricant in capsules.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 535G2ABX9M
    Fucus vesiculosus is a brown seaweed that serves as a thickener, binder, and emulsifier in medicines. It helps create smooth texture and hold ingredients together in liquid and semi-solid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 309GSC92U1
    Glycogen is a carbohydrate derived from animal sources that acts as a binder and filler in tablets and capsules. It helps hold ingredients together and adds bulk to the medicine's solid form.
  • 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 8CRQ2TH63M
    Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
  • UNII 949E3KBJ1I
    Isopropyl titanium triisostearate is a titanium-based compound used in medicines as a glidant and anticaking agent. It helps powders and granules flow smoothly during manufacturing and prevents clumping in the finished product.
  • UNII IV0Z586Z4Y
    A synthetic oil derived from isostearic acid, used as an emollient and lubricant in topical formulations to soften the skin and improve the texture and spreadability of creams, lotions, and ointments.
  • UNII 7F0EV20QYL
    Jojoba oil is a liquid wax extracted from jojoba plant seeds. In medications, it serves as an emollient and carrier oil that helps soften skin, improve texture, and distribute active ingredients evenly in topical formulations.
  • 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 461N1O614Y
    A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
  • UNII S013N99GR8
    Octyldodecyl myristate is a synthetic oil derived from myristic acid. It serves as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping the skin soft.
  • UNII 4A0NCJ6RD6
    Polyglycerin-3 is a synthetic ingredient made by linking multiple glycerin molecules together. It acts as an emulsifier and humectant, helping oils and water mix smoothly and keeping the product from drying out.
  • 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 O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 05Q7CD0E49
    A fatty acid derivative made from natural sugar and lauric acid. It acts as an emulsifier and solubilizer in medicines, helping mix water and oil-based ingredients together and improve how the body absorbs certain drugs.
  • UNII 274KW0O50M
    Sucrose stearate is a compound made from sugar and stearic acid (a fatty substance). It works as an emulsifier and surfactant to help mix oils and water-based ingredients together in the medicine.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesHelianthus Annuus (sunflower) seed wax, jojoba esters, caprylic/capric triglycerides, isopropyl palmitate, olus oil, isostearyl isostearate, zea mays (corn) starch, ricinus communis (castor) seed oil, polyhydroxystearic acid, glycerin, octyldodecanol, behenyl behenate, butyrospermum parkii (shea) butter, capryloyl glycerin / sebacic acid copolymer, aqua / water / eau, octyldodecyl myristate, sucrose laurate, sucrose stearate, acacia decurrens flower wax, polyglycerin-3, euphorbia cerifera (candelilla) wax, glycogen, rosmarinus officinalis (rosemary) leaf extract, fucus vesiculosus (bladderwrack) extract, iron oxides, isopropyl titanium triisostearate.

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.
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/100gthis 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/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

🏛️
2023
On the market since
Jan 2023
📍
2026
Currently FDA-listed
3 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
61649-0068-01 You're viewing this 30 g in 1 TUBE (61649-068-01) 2023-01-25 Active

🧭 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 61649-068-01, 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: 61649-0068-01, written without dashes as 61649006801. 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 61649-0068-01, the first segment (61649) is the labeler code FDA assigned to Attitude DBA 9055-7588 Qubec Inc.; the middle segment (0068) 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 it is currently marketed — but Attitude DBA 9055-7588 Qubec Inc. has reported a marketing end date of 2027-03-25, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
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 4 words ▾

Use Helps prevent sunburn

⏱️ Dosage and Administration 30 words ▾

Directions Adults and children older than 6 months. Apply generously 15 minutes prior to sun exposure. Reapply every 2 hours or after swimming, towel drying, perspiring heavily, or washing .

⚠️ Warnings 53 words ▾

Warnings For external use only. Do not use on damaged or broken skin. Stop use and ask doctor if rash occurs. 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 15 words ▾

Other Information Store at temperatures below 90 °F. Avoid contact of the packaging with water.

🧪 Active Ingredient 5 words ▾

Active ingredient Zinc oxide 10%.

🧪 Inactive Ingredients 77 words ▾

Inactive ingredients Helianthus Annuus (sunflower) seed wax, jojoba esters, caprylic/capric triglycerides, isopropyl palmitate, olus oil, isostearyl isostearate, zea mays (corn) starch, ricinus communis (castor) seed oil, polyhydroxystearic acid, glycerin, octyldodecanol, behenyl behenate, butyrospermum parkii (shea) butter, capryloyl glycerin / sebacic acid copolymer, aqua / water / eau, octyldodecyl myristate, sucrose laurate, sucrose stearate, acacia decurrens flower wax, polyglycerin-3, euphorbia cerifera (candelilla) wax, glycogen, rosmarinus officinalis (rosemary) leaf extract, fucus vesiculosus (bladderwrack) extract, iron oxides, isopropyl titanium triisostearate.

🎯 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 ↗
← 61649-0047-08 · 9055-7588 61649-0070-30 · 9055-7588 →
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.