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GOODAL HEARTLEAF SOOTHING ZINC 100 MINERAL SUNSCREEN Zinc Oxide 219.606 mg/mL Cream — NDC 84532-0003-02 package photo

GOODAL HEARTLEAF SOOTHING ZINC 100 MINERAL SUNSCREEN Zinc Oxide 219.606 mg/mL Cream

by CLIO COSMETICS Co., Ltd. · 1 TUBE in 1 CARTON (84532-003-02) / 50 mL in 1 TUBE (84532-003-01)
NDC 84532-0003-02
🏷️ FDA NDC (as labeled) 84532-003-02 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) 84532-003-02
Product NDC 84532-003
11-digit billing NDC 84532000302
UNII SOI2LOH54Z
Application # M020
SPL Set ID c7b13245-a3e0-4d53-b7fe-9b2c9707ab9e
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-15
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 84532-003-02 — 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 → 84532-0003-02. 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

LabelerCLIO COSMETICS Co., Ltd.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84532
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio4 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 topical cream sunscreen that contains zinc oxide as its active ingredient. Zinc oxide is a mineral UV filter commonly used in sunscreens to reflect and scatter ultraviolet light away from the skin. Products of this type are typically applied to exposed skin to help protect against sun damage. This product is marketed under FDA's over-the-counter monograph rules for sunscreen ingredients.

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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII XRY0V4VZKZ
    A natural oil extracted from Siberian fir tree needles. It's used as a fragrance and flavoring agent in medicines to improve taste and aroma.
  • UNII L4EL31FWIL
    A synthetic peptide (short chain of amino acids) used as a conditioning or texture-enhancing agent in topical formulations. It helps improve product feel and skin compatibility in creams and lotions.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 298PX4M11X
    A synthetic chemical compound that acts as an antioxidant, helping protect the medicine's active ingredients from degradation caused by light, heat, and oxygen during storage and shelf life.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • 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 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 7J5R5W72QM
    C9-12 alkane is a clear, colorless liquid hydrocarbon mixture derived from petroleum. In medicines, it serves as a solvent, lubricant, or component in liquid formulations to help dissolve or suspend active ingredients.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII UB27587839
    A plant-derived oil from Roman chamomile flowers. It's used in medicines as a flavoring agent and fragrance to improve taste and smell.
  • UNII 60F80Z61A9
    A fragrant plant oil extracted from chamomile flowers. It's used as a flavoring agent and fragrance in medicines to improve taste and smell, making the product more pleasant to take.
  • UNII 87L0D4U3M0
    A plant oil derived from clary sage flowers. It's used as a fragrance and flavoring agent in medicines to improve taste and aroma.
  • UNII VCA5491KVF
    A fragrant oil extracted from clove leaves, used as a flavoring and aromatic agent to mask unpleasant tastes or add pleasant scent to medicines.
  • UNII 609A3V1SUA
    A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 21AS8B1BSS
    A silicone-based ingredient that combines dimethicone (silicone oil) with polyethylene glycol. It works as a skin-conditioning agent and texture enhancer, helping smooth the product's feel and improve how it spreads on skin.
  • UNII Z853O1D4TE
    A silicone-based compound derived from hyaluronic acid, used as a skin-conditioning agent and emollient in topical formulations. It helps soften and smooth the product's texture while enhancing moisture retention on the skin's surface.
  • UNII E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII X687XDK09L
    A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
  • 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 U8PA41532G
    A fungal extract from reishi mushroom stems used as a filler and natural ingredient to add bulk to the formulation and support the tablet or capsule structure.
  • 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 3297VXM8Z6
    A plant-derived humectant and emollient made from glycerin and glucose. It helps retain moisture in the formulation and improves texture and spreadability in topical products.
  • UNII RH041UUZ22
    A plant extract from the houttuynia cordata flower, traditionally used in Asian medicine. In formulations, it may serve as a natural flavoring, coloring, or active botanical ingredient carrier.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • 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 4739QA5686
    A natural oil extracted from juniper wood, used as a fragrance and flavoring agent in medicines to improve taste and aroma.
  • UNII 35J49U6PZS
    A silicone-based compound that acts as an emulsifier and skin-conditioning agent in topical formulations. It helps blend oil and water ingredients together and provides a smooth texture to the product.
  • 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 S73ZQI0GXM
    Methyl trimethicone is a silicone-based lubricant and glidant used in tablets and capsules. It reduces friction between particles and equipment during manufacturing, helping the medicine flow smoothly and compress evenly.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII 6UYK2W1W1E
    A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
  • UNII 3K0J1S7QGC
    A fragrant essential oil derived from geranium flowers, used as a flavoring and fragrance agent to improve the taste and aroma of medicines.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • UNII F3IN55X5PO
    A plant-derived essential oil from patchouli leaves. It serves as a fragrance and flavoring agent to improve the taste and smell of the medicine.
  • 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 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 991Z19V2OD
    Propylheptyl caprylate is a synthetic oily liquid made from fatty acids. It's used in medicines as an emollient and solvent to help dissolve active ingredients and improve how the product spreads or absorbs.
  • UNII 8LGU7VM393
    Rosemary leaf oil is a natural aromatic oil extracted from rosemary plants. It's used in medicines as a flavoring agent and preservative to help protect the product from spoilage.
  • 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 WN66R7GL93
    A modified form of hyaluronic acid, a naturally occurring substance that holds water. Used as a thickener, lubricant, and moisture-retaining agent in formulations, especially in topical or injectable products.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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 LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • UNII 9G1ZW13R0G
    A silicone-based polymer that reduces surface tension and improves how liquid medicines spread and are absorbed. It acts as a wetting agent and surfactant in topical formulations.
  • 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.

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

The official label also statesWATER, DIMETHICONE, PROPYLHEPTYL CAPRYLATE, METHYL TRIMETHICONE, BUTYLOCTYL SALICYLATE, PROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, ALCOHOL, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, DICAPRYLYL CARBONATE, C9-12 ALKANE, DISTEARDIMONIUM HECTORITE, METHYL METHACRYLATE CROSSPOLYMER, BENZOTRIAZOLYL DODECYL P-CRESOL, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM SULFATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, 1,2-HEXANEDIOL, SILICA, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CAPRYLYL GLYCOL, DIMETHICONOL, TRISILOXANE, OLEA EUROPAEA (OLIVE) FRUIT OIL, ETHYLHEXYLGLYCERIN, DIPROPYLENE GLYCOL, SODIUM CITRATE, ABIES SIBIRICA OIL, TOCOPHEROL, BUTYLENE GLYCOL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, SALVIA SCLAREA (CLARY) OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, EUGENIA CARYOPHYLLUS (CLOVE) LEAF OIL, ANTHEMIS NOBILIS FLOWER OIL, POGOSTEMON CABLIN OIL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER OIL, JUNIPERUS MEXICANA OIL, NIACINAMIDE, CERAMIDE NP, LACTOBACILLUS FERMENT, PENTYLENE GLYCOL, GLYCERYL GLUCOSIDE, HOUTTUYNIA CORDATA EXTRACT, GANODERMA LUCIDUM (MUSHROOM) STEM EXTRACT, GLYCERIN, DIMETHYLSILANOL HYALURONATE, HYDROLYZED HYALURONIC ACID, HYDROLYZED SODIUM HYALURONATE, SODIUM HYALURONATE, HYALURONIC ACID, POTASSIUM HYALURONATE, SODIUM HYALURONATE CROSSPOLYMER, HYDROXYPROPYLTRIMONIUM HYALURONATE, ACETYL HEXAPEPTIDE-8, SODIUM HYALURONATE DIMETHYLSILANOL, SODIUM ACETYLATED HYALURONATE

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
Goodal Heartleaf Soothing Zinc 100 Mineral Sunscreen 219.606 mg/mLthis 84532-0003-02 CLIO 1 tube — — 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
Mar 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 GOODAL HEARTLEAF SOOTHING ZINC 100 MINERAL SUNSCREEN (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
Death204
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 229 0
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
84532-0003-02 You're viewing this 1 TUBE in 1 CARTON (84532-003-02) / 50 mL in 1 TUBE (84532-003-01) 2026-03-15 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 84532-003-02, 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: 84532-0003-02, written without dashes as 84532000302. 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 84532-0003-02, the first segment (84532) is the labeler code FDA assigned to CLIO COSMETICS Co., Ltd.; the middle segment (0003) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 CLIO COSMETICS Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CLIO COSMETICS Co., Ltd. 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 28 words ▾

Helps prevent sunburn If used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin aging caused by the sun

⏱️ Dosage and Administration 84 words ▾

Apply liberally 15 minutes before sun exposure Reapply at least every two hours Use a water-resistant sunscreen if swimming or sweating 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: 1) Limit time in the sun, especially from 10 a.m. to 2 p.m.

2) Wear long-sleeved shirts, pants, hats, and sunglasses

⚠️ Warnings 34 words ▾

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove.

🧪 Active Ingredient 3 words ▾

Zinc Oxide 21.96%

🧪 Inactive Ingredients 143 words ▾

WATER, DIMETHICONE, PROPYLHEPTYL CAPRYLATE, METHYL TRIMETHICONE, BUTYLOCTYL SALICYLATE, PROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, ALCOHOL, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, DICAPRYLYL CARBONATE, C9-12 ALKANE, DISTEARDIMONIUM HECTORITE, METHYL METHACRYLATE CROSSPOLYMER, BENZOTRIAZOLYL DODECYL P-CRESOL, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM SULFATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, 1,2-HEXANEDIOL, SILICA, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CAPRYLYL GLYCOL, DIMETHICONOL, TRISILOXANE, OLEA EUROPAEA (OLIVE) FRUIT OIL, ETHYLHEXYLGLYCERIN, DIPROPYLENE GLYCOL, SODIUM CITRATE, ABIES SIBIRICA OIL, TOCOPHEROL, BUTYLENE GLYCOL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, SALVIA SCLAREA (CLARY) OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, EUGENIA CARYOPHYLLUS (CLOVE) LEAF OIL, ANTHEMIS NOBILIS FLOWER OIL, POGOSTEMON CABLIN OIL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER OIL, JUNIPERUS MEXICANA OIL, NIACINAMIDE, CERAMIDE NP, LACTOBACILLUS FERMENT, PENTYLENE GLYCOL, GLYCERYL GLUCOSIDE, HOUTTUYNIA CORDATA EXTRACT, GANODERMA LUCIDUM (MUSHROOM) STEM EXTRACT, GLYCERIN, DIMETHYLSILANOL HYALURONATE, HYDROLYZED HYALURONIC ACID, HYDROLYZED SODIUM HYALURONATE, SODIUM HYALURONATE, HYALURONIC ACID, POTASSIUM HYALURONATE, SODIUM HYALURONATE CROSSPOLYMER, HYDROXYPROPYLTRIMONIUM HYALURONATE, ACETYL HEXAPEPTIDE-8, SODIUM HYALURONATE DIMETHYLSILANOL, SODIUM ACETYLATED HYALURONATE

🎯 Purpose 1 words ▾

Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84532-0002-02 · CLIO 84532-0004-02 · CLIO →
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.