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ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30 Zinc oxide 24 g/100g Stick, 8.5 g — NDC 61649-0073-08 package photo

ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30 Zinc oxide 24 g/100g Stick, 8.5 g

by 9055-7588 Quebec Inc. DBA Attitude · 8.5 g in 1 CARTON (61649-073-08)
NDC 61649-0073-08
🏷️ FDA NDC (as labeled) 61649-073-08 billing pads the product segment with a zero
This package
Contains8.5 g Pack sizes2 compare ↓
Also comes in: 30 g 61649-0073-30
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) 61649-073-08
Product NDC 61649-073
11-digit billing NDC 61649007308
UNII SOI2LOH54Z
Application # M020
SPL Set ID 0e9b0642-53ed-ec94-e063-6394a90aec3d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-04-01
Route TOPICAL
Dosage form STICK
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 61649-073-08 — 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 → 61649-0073-08. 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 Quebec Inc. DBA Attitude
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code61649
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio33 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 tinted sunscreen stick containing zinc oxide, a mineral UV filter typically used to help protect skin from ultraviolet rays. The product is applied topically to exposed skin and falls under the FDA's over-the-counter monograph rules for sunscreen products rather than being individually approved. Zinc oxide works by reflecting and scattering UV light away from the skin.

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 H4N855PNZ1
    Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
  • UNII 168S4EO8YJ
    A seaweed extract from brown algae, used as a natural binder and thickening agent to help hold tablet ingredients together and improve product texture.
  • UNII QN83US2B0N
    Ascorbyl palmitate is a fat-soluble form of vitamin C used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down and becoming less stable over time.
  • UNII 2EH13UN8D3
    A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
  • 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 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 0N8672707O
    A starch derived from corn kernels. It acts as a binder to hold tablet ingredients together, a filler to give the tablet bulk, and a disintegrant to help the tablet break apart in your stomach.
  • UNII J7IHY79BKY
    A plant extract from glasswort, a coastal herb. It's used in formulations as a humectant to help retain moisture and may serve as a skin-conditioning agent in topical products.
  • 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 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 930MLC8XGG
    A plant oil extracted from grape seeds, used as an emollient and solvent in medicines. It helps dissolve active ingredients and improve the texture and absorption of topical or liquid formulations.
  • 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 1394NXB9L6
    A plant-derived protein from soybeans that has been broken down into smaller pieces using enzymes. It acts as a binder and texture agent, helping hold ingredients together and improve the product's consistency and mouthfeel.
  • UNII J2S07SB0YL
    A protein derived from wheat that has been broken down into smaller pieces using enzymes. It's used in formulations as a film-former and texturizer to help bind ingredients together and improve product consistency.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • 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 V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • 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 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 68CMP2MB55
    A brown seaweed extract used as a thickener and stabilizer in liquid medicines and suspensions. It helps maintain consistent texture and prevents ingredients from separating.
  • 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 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 TQ1NJP0UMV
    A microscopic marine algae used as a natural coloring and nutritional ingredient. It provides green pigmentation and may serve as a filler or nutritional supplement in certain formulations.
  • UNII 06YD7896S3
    A waxy, fatty substance derived from stearic acid. It acts as a thickener and texture modifier in medicines, helping control how quickly the drug dissolves and improving the product's firmness and consistency.

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

The official label also statesVitis Vinifera (Grape) Seed Oil, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Wax, Coco-Caprylate/Caprate, Octyldodecanol, Helianthus Annuus (Sunflower) Seed Oil, Butyloctyl Salicylate, Mica, Polyhydroxystearic Acid, Cocos Nucifera (Coconut) Oil, Hydrolyzed Vegetable Protein, Glycogen (Zea Mays Phytoglycogen), CI 77492 (Iron Oxides), Tocopherol, CI 77491 (Iron Oxides), Silica, CI 77499 (Iron Oxides), Jojoba Esters, Trihydroxystearin, Ascophyllum Nodosum Extract, Crithmum Maritimum Extract, Fucus Vesiculosus (Bladderwrack) Extract, Laminaria Saccharina Extract, Plankton Extract, Ascorbyl Palmitate.

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: 30 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
Clearly Zinq Mineral Gel Sunscreen BS SPF 60 24 g/100g 62742-4236-01 Allure 96 g — — FDA listed —
ATTITUDE Sunly Kids Mineral sunscreen SPF 50 Watermelon and coco 24 g/100g 61649-0527-01 9055-7588 85 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Face Stick SPF 50 Unscented 24 g/100g 61649-0560-02 9055-7588 1 tube — — FDA listed —
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick SPF 50 Unscented 24 g/100g 61649-0562-02 9055-7588 1 tube — — FDA listed —
Eucerin Baby Sensitive Mineral SPF 50 Sunscreen 24 g/100g 66800-4000-01 Beiersdorf 118 g — — FDA listed —
Lino 24 g/100g 84749-0001-01 Lino 30 g — — FDA listed —
ATTITUDE Sunly Kids Mineral Sunscreen Stick SPF 50 Watermelon and Coco 24 g/100g 61649-0547-01 9055-7588 60 g — — FDA listed —
ATTITUDE Sunly Baby Mineral Sunscreen Face Stick SPF 50 Unscented 24 g/100g 61649-0561-02 9055-7588 1 tube — — FDA listed —
ATTITUDE Sunly Baby Mineral sunscreen SPF 50 Unscented 24 g/100g 61649-0521-01 9055-7588 85 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Unscented 24 g/100g 61649-0540-01 9055-7588 60 g — — FDA listed —
Land Shark Zinky SPF 36 Pacific Purple 24 g/100g 52854-0645-01 Tropical 14 g — — FDA listed —
ATTITUDE Oceanly Phyto-Sun Tinted Cream SPF 30 24 g/100g 61649-0070-30 9055-7588 30 g — — FDA listed —
ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30 24 g/100gthis 61649-0073-08 9055-7588 8.5 g — — FDA listed —
ATTITUDE Sunly Kids Mineral Sunscreen Stick SPF 50 Unscented 24 g/100g 61649-0542-01 9055-7588 60 g — — FDA listed —
ATTITUDE Sensitive natural Mineral Sunscreen Stick SPF 50 Unscented 24 g/100g 61649-0544-01 9055-7588 60 g — — FDA listed —
Land Shark Zinky SPF 36 Azure Blue 24 g/100g 52854-0615-01 Tropical 14 g — — FDA listed —
ATTITUDE Oceanly Phyto-Sun Tinted Shimmer Cream SPF 30 24 g/100g 61649-0071-08 9055-7588 8.5 g — — FDA listed —
ATTITUDE Sunly Kids Mineral sunscreen SPF 50 Unscented 24 g/100g 61649-0522-01 9055-7588 85 g — — FDA listed —
ATTITUDE Sensitive natural baby Mineral sunscreen SPF 50 Unscented 24 g/100g 61649-0524-01 9055-7588 85 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Sun kissed vanilla 24 g/100g 61649-0548-01 9055-7588 60 g — — FDA listed —
ATTITUDE Sunly Mineral sunscreen SPF 50 Tropical coco 24 g/100g 61649-0523-01 9055-7588 85 g — — FDA listed —
ATTITUDE Sunly Mineral sunscreen SPF 50 Sun kissed vanilla 24 g/100g 61649-0528-01 9055-7588 85 g — — FDA listed —
Land Shark Zinky SPF 36 Pink Beach 24 g/100g 52854-0625-01 Tropical 14 g — — FDA listed —
ATTITUDE Sunly Mineral sunscreen SPF 50 Unscented 24 g/100g 61649-0520-01 9055-7588 85 g — — FDA listed —
ATTITUDE Sunly Baby Mineral Sunscreen Stick SPF 50 Unscented 24 g/100g 61649-0541-01 9055-7588 60 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Tropical coco 24 g/100g 61649-0543-01 9055-7588 60 g — — FDA listed —
Eucerin Sensitive Mineral SPF 50 Sunscreen 24 g/100g 66800-1000-01 Beiersdorf 118 g — — FDA listed —
Utu Broad Spectrum SPF 50 Tinted Sunscreen-Stick 24 g/100g 87952-0001-02 Utu 28 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

🏛️
2024
On the market since
Apr 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 Oceanly Phyto-Sun Tinted Oil SPF 30 (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%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 272 82
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 NDCDescription Marketing startStatus
61649-0073-08 You're viewing this 8.5 g in 1 CARTON (61649-073-08) 2024-04-01 Active
61649-0073-30 30 g in 1 CARTON (61649-073-30) 2024-04-01 Active

Pack size FAQ

What quantity is in NDC 61649-0073-08?
NDC 61649-0073-08 contains 8.5 g — 8.5 g in 1 carton.
What is the difference between NDC 61649-0073-08 and NDC 61649-0073-30?
Both are ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30 Zinc oxide 24 g/100g Stick — the drug itself is identical. NDC 61649-0073-08 is the 8.5 g package, while NDC 61649-0073-30 is the 30 g package.
What NDC number is used to bill for this package of ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30 Zinc oxide 24 g/100g Stick?
Bill NDC 61649-0073-08 — the 11-digit billing format is 61649007308. 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 61649-073-08, 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: 61649-0073-08, written without dashes as 61649007308. 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 61649-0073-08, the first segment (61649) is the labeler code FDA assigned to 9055-7588 Quebec Inc. DBA Attitude; the middle segment (0073) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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 Quebec 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 30 g (61649-0073-30). 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 Quebec 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 3 words ▾

Helps prevent sunburn.

⏱️ Dosage and Administration 80 words ▾

Adults. Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours.

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 53 words ▾

For external use only. Do not use on broken skin. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. 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 16 words ▾

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

🧪 Active Ingredient 4 words ▾

Zinc oxide (24 %)

🧪 Inactive Ingredients 69 words ▾

Vitis Vinifera (Grape) Seed Oil, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Wax, Coco-Caprylate/Caprate, Octyldodecanol, Helianthus Annuus (Sunflower) Seed Oil, Butyloctyl Salicylate, Mica, Polyhydroxystearic Acid, Cocos Nucifera (Coconut) Oil, Hydrolyzed Vegetable Protein, Glycogen (Zea Mays Phytoglycogen), CI 77492 (Iron Oxides), Tocopherol, CI 77491 (Iron Oxides), Silica, CI 77499 (Iron Oxides), Jojoba Esters, Trihydroxystearin, Ascophyllum Nodosum Extract, Crithmum Maritimum Extract, Fucus Vesiculosus (Bladderwrack) Extract, Laminaria Saccharina Extract, Plankton Extract, Ascorbyl Palmitate.

🎯 Purpose 1 words ▾

Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61649-0071-08 · 9055-7588 61649-0090-60 · 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.