HomeNDC LookupIngredientsZinc Oxide › 42681-0062-01
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365 WHOLE FOODS MARKET SPORT MINERAL SPF 30 Zinc Oxide 20 g/100g Lotion, 44 g

by Whole Foods Market, Inc. · 44 g in 1 TUBE (42681-0062-1)
NDC 42681-0062-01
🏷️ FDA NDC (as labeled) 42681-0062-1 billing pads the package segment with a zero
This package
Contains44 g Pack sizes2 compare ↓
Also comes in: 170 g 42681-0062-02
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 →
⚠️
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) 42681-0062-1
Product NDC 42681-0062
11-digit billing NDC 42681006201
UNII SOI2LOH54Z
UPC 0099482551056
Application # M020
SPL Set ID 6caf656c-246f-469e-84f8-98f80b84c65e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-01
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 42681-0062-1 — a 5-4-1 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 package segment → 42681-0062-01. 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

LabelerWhole Foods Market, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code42681
First marketedJul 2026
Product typeHuman Otc Drug
Portfolio46 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 topical lotion sunscreen that contains zinc oxide as its active ingredient. Zinc oxide is a mineral UV filter commonly used in sunscreen products to help block ultraviolet radiation from the sun. The lotion is formulated to an SPF 30 level and is marketed as an over-the-counter monograph sunscreen, meaning it follows FDA's established rules for sunscreen ingredients and labeling rather than being individually approved through a separate application process.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

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 RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • UNII P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • UNII UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • 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 YY7C30VXJT
    A natural plant extract from cucumber that adds flavor and freshness to medicines. It may also serve as a moisturizing agent or mild preservative in topical or oral formulations.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • UNII ZF94AP8MEY
    Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
  • 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 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 7Q0OK5DOT4
    A plant-derived emulsifier made from glycerin and ricinoleic acid (from castor oil). It helps blend oil and water-based ingredients together in formulations and improves product texture and stability.
  • UNII 687U3PEB2Y
    A complex emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients together and improves the texture and stability of creams, lotions, and other formulated products.
  • UNII MHT97MG5P8
    Rosa canina seed oil is a plant-based oil extracted from wild rose seeds. It's used in medicines as an emollient and carrier, helping to soften formulations and distribute active ingredients evenly throughout the product.
  • 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 0W8RRI5W5A
    A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.
  • UNII PN88NW0KPK
    A synthetic polymer made from citric acid and long-chain alcohols. It acts as a thickener and stabilizer in creams and lotions, helping maintain consistent texture and prevent ingredient separation.
  • 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.

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

The official label also statesAloe Barbadensis (Aloe Vera) Leaf Juice Organic Ingredients, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Caprylhydroxamic Acid, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexylglycerin, Glycerin, Glyceryl Caprylate, Hyaluronic Acid, Hydrogenated Castor Oil, Magnesium Sulfate, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Rosa Canina (Rosehip) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Sorbitan Sesquioleate, Stearyl/Octyldodecyl Citrate Crosspolymer, Water

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 DailyMedingredient 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.
Try another pack size: 170 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
restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex 20 g/100g 57670-0000-00 RESTORSEA 1 tube FDA listed
SPF 50 Mineral Sunscreen 20 g/100g 72667-0101-01 Inspec 50 g FDA listed
Radically Rejuvenating SPF Day Cream 20 g/100g 54136-0152-52 Better 52 g FDA listed
Seriously Soothing SPF Day Cream 20 g/100g 54136-0179-52 Better 52 g FDA listed
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0100-60 9055-7588 60 g FDA listed
Attitude Kids Oatmeal sensitive mineral sunscreen unscented SPF 30 20 g/100g 61649-0162-75 9055-7588 75 g FDA listed
Attitude Oatmeal sensitive mineral sunscreen unscented SPF 30 20 g/100g 61649-0165-15 9055-7588 150 g FDA listed
Zinc Oxide 20 g/100g 69771-0109-38 Geri-Gentle 1 tube FDA listed
Aloe UP SPF 33 Mineral 20 g/100g 61477-0231-01 Aloe 30 g FDA listed
Attitude mineral sunscreen orange blossom SPF 30 20 g/100g 61649-0022-15 9055-7588 150 g FDA listed
Attitude mineral sunscreen unscented SPF 30 20 g/100g 61649-0030-85 Attitude 85 g Discontinued
Attitude mineral sunscreen tropical SPF 30 20 g/100g 61649-0031-85 Attitude 85 g Discontinued
ATTITUDE Sunly Kids Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0098-60 9055-7588 60 g FDA listed
ATTITUDE Sunly Tinted Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0097-20 9055-7588 20 g FDA listed
All Good Mineral Sport Sunscreen Sunstick SPF 30 20 g/100g 75786-0220-01 Elemental 17 g FDA listed
Mackenzies SPF 40 Ocean Safe Sunscreen 20 g/100g 80325-0040-02 Naturally 80 g FDA listed
Zinctral 20 g/100g 59088-0627-05 PureTek 57 g FDA listed
Aloe Up SPF 50 Mineral 20 g/100g 61477-0234-01 Aloe 89 g FDA listed
Aloe Up SPF 50 Kids Mineral 20 g/100g 61477-0236-01 Aloe 89 g FDA listed
Attitude mineral sunscreen tropical SPF 30 20 g/100g 61649-0021-15 9055-7588 150 g FDA listed
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Terracotta 20 g/100g 61649-0046-08 9055-7588 8.5 g FDA listed
ATTITUDE Sunly Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0090-60 9055-7588 60 g FDA listed
ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30 20 g/100g 61649-0092-60 9055-7588 60 g FDA listed
Attitude Kids mineral sunscreen unscented SPF 30 20 g/100g 61649-0160-15 9055-7588 150 g FDA listed
Mineral Defense Sport Ceramide Spf-30 20 g/100g 73054-0108-11 SOLARA 1 applicator FDA listed
ProCure Zinc Oxide 20 g/100g 55681-0017-01 Twin 28.3 g FDA listed
Attitude Kids mineral sunscreen unscented SPF 30 20 g/100g 61649-0038-85 Attitude 85 g Discontinued
Attitude tinted mineral sunscreen face unscented SPF 30 20 g/100g 61649-0041-30 Attitude 30 g Discontinued
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0101-20 9055-7588 20 g FDA listed
All Good Coconut Mineral Sunscreen Sunstick SPF 30 20 g/100g 75786-0221-01 Elemental 17 g FDA listed
ATTITUDE Sunly Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0094-20 9055-7588 20 g FDA listed
Medpride 20 g/100g 52410-3040-03 Shield 28 g FDA listed
Medline 20 g/100g 53329-0220-07 Medline 14 g FDA listed
ATTITUDE Sunly Mineral Sunscreen Stick Tropical SPF 30 20 g/100g 61649-0091-60 9055-7588 60 g FDA listed
Bio Spectra Attitude 20 g/100g 61649-0120-01 9055-7588 75 g FDA listed
BLDG Active Skin Repair Sun Stick Performance Sunscreen 20 g/100g 70489-1423-01 Innovacyn, 15 g FDA listed
Stream2Sea SPF 50 20 g/100g 69555-0050-01 Stream2Sea 1 jar FDA listed
Stream2Sea Sport Lip Balm SPF 50 20 g/100g 69555-0500-01 Stream2Sea, 4 g FDA listed
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0099-20 9055-7588 20 g FDA listed
Bio Spectra Attitude 20 g/100g 61649-0110-15 9055-7588 150 g FDA listed
dabur 20 g/100g 68747-3040-03 Dabur 28 g FDA listed
New Kid on the Block 20 g/100g 84568-0552-12 Dimples 106.8 g FDA listed
Lasso Tallow Sunscreen Spf 50 20 g/100g 87761-0004-01 Moes 140 g FDA listed
Procure 20 g/100g 55681-0304-03 TWIN 28.3 g FDA listed
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose 20 g/100g 61649-0045-08 9055-7588 8.5 g FDA listed
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Peachy Shell 20 g/100g 61649-0047-08 9055-7588 8.5 g FDA listed
Endit Zinc Oxide Skin Protectant 20 g/100g 64068-0402-01 Endit 454 g FDA listed
Stream2Sea Reef Safer Mineral Sunscreen SPF40 20 g/100g 69555-0400-10 Stream2Sea, 1 jar FDA listed
365 Whole Foods Market Sport Mineral Spf 30 20 g/100gthis 42681-0062-01 Whole 44 g FDA listed
Stream2Sea Ecostock SPF 40 Sunscreen 20 g/100g 69555-0401-01 Stream2Sea, 14 g FDA listed
Utu Broad Spectrum SPF 30 Moisturizing Body Sunscreen 20 g/100g 87952-0004-02 Utu 1 bottle 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

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 365 WHOLE FOODS MARKET SPORT MINERAL 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%

Serious outcomes

Hospitalization988
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 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
42681-0062-01 You're viewing this 44 g in 1 TUBE (42681-0062-1) 2026-07-01 Active
42681-0062-02 170 g in 1 TUBE (42681-0062-2) 2026-07-01 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 42681-0062-01?
NDC 42681-0062-01 contains 44 g — 44 g in 1 tube.
What is the difference between NDC 42681-0062-01 and NDC 42681-0062-02?
Both are 365 WHOLE FOODS MARKET SPORT MINERAL SPF 30 Zinc Oxide 20 g/100g Lotion — the drug itself is identical. NDC 42681-0062-01 is the 44 g package, while NDC 42681-0062-02 is the 170 g package.
What NDC number is used to bill for this package of 365 WHOLE FOODS MARKET SPORT MINERAL SPF 30 Zinc Oxide 20 g/100g Lotion?
Bill NDC 42681-0062-01 — the 11-digit billing format is 42681006201. 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 — Not published for this NDC No photo available yet for this listing.
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 42681-0062-1, 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: 42681-0062-01, written without dashes as 42681006201. 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 42681-0062-01, the first segment (42681) is the labeler code FDA assigned to Whole Foods Market, Inc.; the middle segment (0062) 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 Whole Foods Market, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 170 g (42681-0062-02). 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?
Whole Foods Market, 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 30 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 99 words

Directions apply liberally and evenly 15 minutes before sun exposure and as needed reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: ask a doctor

⚠️ Warnings 54 words

Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and contact a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

📦 Storage and Handling 11 words

Other information Protect this product from excessive heat and direct sun.

🧪 Active Ingredient 5 words

Active ingredient Zinc Oxide 20%

🧪 Inactive Ingredients 75 words

Inactive ingredients Aloe Barbadensis (Aloe Vera) Leaf Juice Organic Ingredients , Butyrospermum Parkii (Shea) Butter , Calendula Officinalis (Marigold) Flower Extract , Camellia Sinensis (Green Tea) Leaf Extract , Caprylic/Capric Triglyceride, Caprylhydroxamic Acid, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract , Ethylhexylglycerin, Glycerin, Glyceryl Caprylate, Hyaluronic Acid, Hydrogenated Castor Oil, Magnesium Sulfate, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Rosa Canina (Rosehip) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil , Sorbitan Sesquioleate, Stearyl/Octyldodecyl Citrate Crosspolymer, Water

🎯 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 ↗
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.