Home › NDC Lookup › Ingredients › Zinc Oxide › 61649-0528-01
ATTITUDE Sunly Mineral sunscreen SPF 50 Sun kissed vanilla ZINC OXIDE 24 g/100g Cream, 85 g — NDC 61649-0528-01 package photo

ATTITUDE Sunly Mineral sunscreen SPF 50 Sun kissed vanilla ZINC OXIDE 24 g/100g Cream, 85 g

by 9055-7588 Qubec Inc.DBA ATTITUDE · 85 g in 1 TUBE (61649-528-01)
NDC 61649-0528-01
🏷️ FDA NDC (as labeled) 61649-528-01 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) 61649-528-01
Product NDC 61649-528
11-digit billing NDC 61649052801
UNII SOI2LOH54Z
Application # M020
SPL Set ID 44aca181-2a90-20a6-e063-6394a90aff47
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-15
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 61649-528-01 — 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 → 61649-0528-01. 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 marketedDec 2025
Product typeHuman Otc Drug
Portfolio32 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 mineral sunscreen cream applied to skin to help protect against sun damage. It contains zinc oxide, a mineral UV filter that works by reflecting and scattering ultraviolet light away from the skin. This product is marketed as an over-the-counter sunscreen under FDA's monograph rules for sunscreen ingredients and is formulated with a sun-kissed vanilla scent.

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 MDD00FOW8J
    A fragrant organic compound used as a flavoring agent to add a rose-like or fruity scent and taste to medicines, making them more pleasant to take.
  • 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 5C5403N26O
    Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize 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.
  • 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 75D21FL1PI
    A synthetic liquid derived from butylene glycol and fatty acids. It acts as an emollient and solvent to help dissolve or suspend active ingredients, improving texture and absorption in topical or oral formulations.
  • UNII 114P5I43UJ
    A hydrocarbon oil derived from petroleum, containing 13 to 15 carbon atoms per molecule. It serves as a lubricant and glidant in tablets and capsules to reduce friction during manufacturing and improve powder flow.
  • UNII 3JRB8A35M0
    A mineral compound made from calcium, aluminum, boron, and silicon. It's used as a colorant and opacifying agent to give medicines their appearance and color, and sometimes helps protect ingredients from light damage.
  • 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 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 77JZM5516Z
    A liquid oil derived from coconut sources, used as a solvent and emollient to help dissolve active ingredients and improve how the medicine spreads or absorbs in the formulation.
  • UNII R8WTH25YS2
    Glyceryl dibehenate is a wax-like substance made from behenate fatty acids and glycerol. It functions as a binder and release-control agent in tablets and capsules, helping hold ingredients together and regulate how quickly the medicine dissolves and releases in your body.
  • 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 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 W77QUB6GXO
    Heptyl undecylenate is a synthetic ester compound used as a preservative and antimicrobial agent in medications. It helps prevent bacterial and fungal growth to maintain product stability and safety during storage.
  • 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 DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII KY6D986DKL
    A plant-derived oil mixture that acts as an emulsifier and solubilizer, helping blend oil and water-based ingredients together and improve how the medicine dissolves and absorbs in the body.
  • UNII 3GW44CIE3Y
    A synthetic fragrance compound used to add pleasant scent to medicines. It helps mask unpleasant tastes or odors in oral products and may improve patient acceptance of the medication.
  • 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 OK17S3S98K
    A waxy, fatty substance derived from plant or animal sources. It acts as a lubricant and glidant to help the medicine flow smoothly during manufacturing and tablet compression.
  • UNII 67733846OW
    Phenethyl acetate is a synthetic fragrance compound used as a flavoring agent in medicines. It adds a pleasant fruit or floral aroma to help mask unpleasant tastes or odors in the formulation.
  • 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 M51422LRAM
    Polyglycerin-6 is a synthetic compound made from glycerin molecules linked together. In medicines, it acts as an emulsifier and humectant, helping mix oil and water-based ingredients and retain moisture in the formulation.
  • UNII 9229XJ4V12
    A synthetic emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients in formulations, keeping them mixed and preventing separation.
  • UNII YPM0ZOC2HR
    A synthetic emulsifier derived from glycerin and castor oil. It helps mix oil and water-based ingredients together in the formulation to create a uniform product and improve texture.
  • 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 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII F53961BX4F
    A synthetic oil made from propanediol and fatty acids. It acts as an emollient and solvent in medicines, helping dissolve active ingredients and improve how the product spreads or absorbs.
  • UNII 8D08K3S51E
    Propylene carbonate is a clear liquid solvent derived from propylene. It helps dissolve or suspend active ingredients in liquid medicines and can improve how well the product flows and mixes.
  • 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII OLX698AH5P
    A clay mineral processed with a quaternary ammonium compound. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesAqua / Water / Eau, Butylene Glycol Dicaprylate/Dicaprate, Propanediol Dicaprylate/Caprate, Dicaprylyl Ether, C13-15 Alkane, Calcium Aluminum Borosilicate, Propanediol, Jojoba Esters, Mica, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyhydroxystearate, Coco-Caprylate/Caprate, Magnesium Sulfate, Maleated Soybean Oil Glyceryl / Octyldodecanol Esters (Soybean/Soja), Polyglyceryl-6 Polyricinoleate, Helianthus Annuus (Sunflower) Seed Wax, Heptyl Undecylenate, Polyhydroxystearic Acid, Glyceryl Behenate, Polyglycerin-6, Acacia Senegal Gum, Acacia Decurrens Flower Wax, Polyglycerin-3, Xanthan Gum, Sodium Benzoate, Stearalkonium Hectorite, Propylene Carbonate, Silica, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil, Ascorbyl Palmitate, Rose Ketones*, Methyldihydrojasmonate*, Pentadecalactone*, Phenethyl Acetate*, Triethyl Citrate*, Vanillin*, *Fragrance (Parfum).

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 gPer 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
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/100g 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/100gthis 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

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year 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
61649-0528-01 You're viewing this 85 g in 1 TUBE (61649-528-01) 2025-12-15 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 61649-528-01, 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: 61649-0528-01, written without dashes as 61649052801. 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 61649-0528-01, the first segment (61649) is the labeler code FDA assigned to 9055-7588 Qubec Inc.DBA ATTITUDE; the middle segment (0528) 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.
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 3 words ▾

Helps prevent sunburn

⏱️ Dosage and Administration 99 words ▾

Adultds and children older than 6 months • Apply generously 15 min before sun exposure • Reapply at least every 2 h • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value ≥ 15 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 • Children under 6 months of age: Ask a doctor.

⚠️ Warnings 61 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 Allergens-Soybean (Maleated Soybean Oil Glyceryl / Octyldodecanol Esters)

📦 Storage and Handling 10 words ▾

Store at temperatures < 90F and protect from direct sun.

🧪 Active Ingredient 4 words ▾

Zinc oxide (24 %)

🧪 Inactive Ingredients 86 words ▾

Aqua / Water / Eau, Butylene Glycol Dicaprylate/Dicaprate, Propanediol Dicaprylate/Caprate, Dicaprylyl Ether, C13-15 Alkane, Calcium Aluminum Borosilicate, Propanediol, Jojoba Esters, Mica, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyhydroxystearate, Coco-Caprylate/Caprate, Magnesium Sulfate, Maleated Soybean Oil Glyceryl / Octyldodecanol Esters (Soybean/Soja), Polyglyceryl-6 Polyricinoleate, Helianthus Annuus (Sunflower) Seed Wax, Heptyl Undecylenate, Polyhydroxystearic Acid, Glyceryl Behenate, Polyglycerin-6, Acacia Senegal Gum, Acacia Decurrens Flower Wax, Polyglycerin-3, Xanthan Gum, Sodium Benzoate, Stearalkonium Hectorite, Propylene Carbonate, Silica, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil, Ascorbyl Palmitate, Rose Ketones*, Methyldihydrojasmonate*, Pentadecalactone*, Phenethyl Acetate*, Triethyl Citrate*, Vanillin*, *Fragrance (Parfum).

🎯 Purpose 1 words ▾

Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61649-0527-01 · 9055-7588 61649-0530-01 · 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.