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PEACH AND LILY SUN COVER MINERAL SUNSCREEN SPF 30 ZINC OXIDE 15.98 g/100mL Lotion — NDC 68577-298-00 (Billing 68577-0298-00)

by COSMAX USA · 1 TUBE, WITH APPLICATOR in 1 CARTON / 50 mL in 1 TUBE, WITH APPLICATOR

This is a package of PEACH AND LILY SUN COVER MINERAL SUNSCREEN SPF 30 ZINC OXIDE 15.98 g/100mL Lotion from COSMAX USA, marketed since Feb 2026 and currently FDA-listed. It is this product's only package size.

NDC 68577-0298-00
🏷️ FDA NDC (as labeled) 68577-298-00 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 68577-298-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68577 labeler · 298 product · 00 package
Package marketed since
Feb 23, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6857729800 9
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68577-298-00
Product NDC 68577-298
11-digit billing NDC 68577029800
UNII SOI2LOH54Z
Application # M020
SPL Set ID 564bb5f9-5ac5-548b-e063-6394a90a8462
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-23
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 68577-298-00 — 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 → 68577-0298-00. 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.

Clinical

🧪 What is this product?

This is a mineral sunscreen lotion applied to the skin to help protect against sun damage. The active ingredient is zinc oxide, a physical (mineral) UV filter that reflects and scatters ultraviolet light away from the skin. This product is marketed as an over-the-counter sunscreen under FDA's monograph rules for sunscreen products. It is formulated to provide SPF 30 protection.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68577-0298-00 You're viewing this Main listing 1 TUBE, WITH APPLICATOR in 1 CARTON / 50 mL in 1 TUBE, WITH APPLICATOR 2026-02-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Peach And Lily Sun Cover Mineral Sunscreen Spf 30 15.98 g/100mLthis 68577-0298-00 COSMAX 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
Feb 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.

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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 8XWR7NN42F
    A sugar alcohol derived from natural sources, used as a sweetener and filler in medicines. It helps improve taste and provides bulk to tablets and powders without adding significant calories.
  • UNII 1QR1QRA9BU
    A fatty alcohol derived from peanut oil or made synthetically. It serves as an emollient and thickener in creams and ointments, helping create smooth texture and improve product consistency.
  • UNII 6JVW35JOOJ
    Arachidyl glucoside is a plant-derived emulsifier and skin-conditioning agent made from arachidyl alcohol and glucose. It helps mix oil and water-based ingredients together in formulations and improves product texture and spreadability.
  • UNII 4V59G5UW9X
    Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • UNII E4M09UY5BL
    A dried plant material from sweet wormwood. It's used in some formulations as a natural filler or ingredient to add bulk to the product.
  • UNII 8XPW32PR7I
    Astaxanthin is a reddish pigment from algae and other organisms, used in medicines as a colorant and antioxidant to maintain product stability and appearance during storage.
  • UNII 9G1OE216XY
    Docosanol is a waxy, fatty alcohol derived from plant sources. It acts as an emollient and thickener in topical medicines, helping to soften the skin and improve product texture and stability.
  • UNII 6L246LAM9T
    A synthetic oil derived from glycerol and adipic acid. It acts as an emulsifier and solubilizer in medicines, helping mix ingredients that don't naturally blend together and improving how the body absorbs the active drug.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII 128UH9LOAE
    Broccoli sprout is a plant-based ingredient derived from young broccoli plants. It may be used as a natural coloring agent, flavoring component, or nutritional additive in formulations.
  • 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 A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • 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 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 DI775RT244
    A natural fatty acid derived from coconut or palm oil. Used as an emulsifier and solubilizer to help mix oil and water components and improve how the medicine dissolves and absorbs in the body.
  • UNII 5C69YCD2YJ
    Carrageenan is a natural thickener and stabilizer extracted from red seaweed. It's used in medicines to create gel-like textures, improve consistency, and help keep ingredients from separating during storage.
  • UNII 4YS74Q4G4J
    A plant extract from Centella asiatica containing natural compounds called triterpenoids. It's used as an active ingredient in some formulations for its purported skin-supporting properties, though it functions as a botanical additive rather than a structural component of the medicine.
  • 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 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • 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 BD70459I50
    Citrus bioflavonoids are plant compounds extracted from citrus fruits. In medicines, they act as antioxidants and may help improve ingredient stability and absorption.
  • UNII ICS790225B
    A plant-derived cleaning agent made from coconut oil and glucose. It works as a surfactant and emulsifier to help mix oil and water-based ingredients together in the formulation.
  • 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 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 3GK5AZW0KX
    A natural oil extract from the microalgae Haematococcus pluvialis, rich in carotenoids and fatty acids. Used as a colorant and nutritional ingredient to enhance the product's appearance and composition.
  • UNII H1109Z9J4N
    A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
  • UNII G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII 86FQE96TZ4
    A synthetic polymer, this ingredient acts as a thickener and suspending agent in liquid formulations. It helps maintain uniform consistency and keeps particles evenly distributed throughout the medicine.
  • UNII X33R8U0062
    Isostearic acid is a fatty acid derived from vegetable oils. It acts as an emulsifier and lubricant in medicines, helping blend ingredients together and reducing friction during tablet or capsule manufacturing.
  • UNII 834K0WOS5G
    A natural fat extracted from sunflower seeds. It acts as an emulsifier and lubricant in medicines, helping mix ingredients that don't normally blend together and allowing the product to flow smoothly during manufacturing.
  • UNII 50JZ5Z98QY
    A plant extract from maritime pine bark, used as a natural coloring agent and antioxidant in medicines to maintain product stability and appearance.
  • 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 HO4ZT5S86C
    A synthetic peptide derived from amino acids, used as a skin-conditioning agent and emollient in topical formulations to help soften and smooth the skin surface.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII 89NA02M4RX
    Pectin is a natural fiber extracted from fruit and plants. It's used in medicines as a thickener, binder, and gelling agent to create the right texture and help the product hold together.
  • UNII 9D7IK5483F
    A synthetic oil derived from pentaerythritol and isostearic acid. It acts as an emollient and texture enhancer in topical formulations, helping create a smooth, spreadable consistency and improve skin feel.
  • UNII Q7UI015FF9
    A synthetic polymer material used as a thickener and stabilizer in liquid formulations. It helps create the right texture and prevents separation of ingredients in medicines and topical products.
  • 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 4T2L7QI313
    A waxy, plant-derived thickener made from glycerol and behenic acid. It's used as an emulsifier and stabilizer to help blend oil and water-based ingredients together and maintain texture in creams and lotions.
  • UNII ETY9Q81E2T
    A synthetic emulsifier made from glycerin and stearic acid. It helps blend oil and water-based ingredients together so the medicine mixes evenly and stays stable.
  • 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 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 M6S840WXG5
    Purslane is a plant-derived ingredient used in pharmaceuticals as a natural source of beneficial compounds. It functions as an antioxidant and anti-inflammatory agent to help stabilize the formula and support product shelf life.
  • 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 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 01S2G2C1E4
    Sorbitan isostearate is an emulsifier derived from sorbitol and isostearic acid. It helps mix oil and water-based ingredients together and keeps them blended throughout the medicine's shelf life.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • 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 EJ27X76M46
    Ubidecarenone is a naturally occurring compound found in cells that helps produce energy. In medicines, it acts as an antioxidant and may help stabilize the product while supporting cellular function in the body.
  • 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 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.
  • UNII VCQ006KQ1E
    Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.
  • UNII O0IEZ166FB
    A natural sugar substitute derived from plant sources, used as a sweetener and humectant to improve taste and help retain moisture in the medication.

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

The official label also statesInactive ingredients: Water,Caprylic/Capric Triglyceride, Propanediol, C12-15 Alkyl Benzoate, Polyglyceryl-6 Stearate, Glycerin, Niacinamide, Polyhydroxystearic Acid, Arachidyl Alcohol, Squalane, Bis-Diglyceryl Polyacyladipate-2, Panthenol, Cetearyl Alcohol, 1,2-Hexanediol, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Behenyl Alcohol, Argania Spinosa Kernel Oil, Hydroxyacetophenone, Tocopheryl Acetate, Arachidyl Glucoside, Coco-Glucoside, Polyglyceryl-6 Behenate, Iron Oxides (CI 77492), Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Pectin, Xanthan Gum, Carrageenan, Allantoin, Caprylhydroxamic Acid, Polyacrylate Crosspolymer-6, Ethylhexylglycerin, Sodium Citrate, Bisabolol, Sorbitan Isostearate, Iron Oxides (CI 77491), Pentaerythrityl Tetraisostearate, Glyceryl Glucoside, Hydrolyzed Hyaluronic Acid, Sodium Hyaluronate, Hydrogenated Lecithin, Xylitylglucoside, Anhydroxylitol, Butylene Glycol, Camellia Sinensis Leaf Extract, Xylitol, Centella Asiatica Extract, Aloe Barbadensis Leaf Extract, Artemisia Annua Extract, Ceramide NP, Ubiquinone, Haematococcus Pluvialis Oil, Propylene Carbonate, Stearalkonium Hectorite, Bioflavonoids, Tocopherol, Iron Oxides (CI 77499), Portulaca Oleracea Extract, Brassica Oleracea Italica (Broccoli) Extract, Astaxanthin, Palmitoyl Hexapeptide-12, Pinus Pinaster Bark Extract.

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.

Manufacturer & labeler

LabelerCOSMAX USA
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code68577
First marketedFeb 2026
Product typeHuman Otc Drug
Portfolio16 products on file

More NDCs from COSMAX USA labeler code 68577

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.

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

USES 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 94 words ▾

DIRECTIONS Directions: Apply generously and evenly 15 minutes before sun exposure Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Sun Protection Measure : 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. - 2p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: 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 ask doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or call Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active ingredient Zinc Oxide 15.98%

🧪 Inactive Ingredients 131 words ▾

Inactive ingredients: Water,Caprylic/Capric Triglyceride, Propanediol, C12-15 Alkyl Benzoate, Polyglyceryl-6 Stearate, Glycerin, Niacinamide, Polyhydroxystearic Acid, Arachidyl Alcohol, Squalane, Bis-Diglyceryl Polyacyladipate-2, Panthenol, Cetearyl Alcohol, 1,2-Hexanediol, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Behenyl Alcohol, Argania Spinosa Kernel Oil, Hydroxyacetophenone, Tocopheryl Acetate, Arachidyl Glucoside, Coco-Glucoside, Polyglyceryl-6 Behenate, Iron Oxides (CI 77492), Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Pectin, Xanthan Gum, Carrageenan, Allantoin, Caprylhydroxamic Acid, Polyacrylate Crosspolymer-6, Ethylhexylglycerin, Sodium Citrate, Bisabolol, Sorbitan Isostearate, Iron Oxides (CI 77491), Pentaerythrityl Tetraisostearate, Glyceryl Glucoside, Hydrolyzed Hyaluronic Acid, Sodium Hyaluronate, Hydrogenated Lecithin, Xylitylglucoside, Anhydroxylitol, Butylene Glycol, Camellia Sinensis Leaf Extract, Xylitol, Centella Asiatica Extract, Aloe Barbadensis Leaf Extract, Artemisia Annua Extract, Ceramide NP, Ubiquinone, Haematococcus Pluvialis Oil, Propylene Carbonate, Stearalkonium Hectorite, Bioflavonoids, Tocopherol, Iron Oxides (CI 77499), Portulaca Oleracea Extract, Brassica Oleracea Italica (Broccoli) Extract, Astaxanthin, Palmitoyl Hexapeptide-12, Pinus Pinaster Bark Extract.

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin.

📄 When Using This Product 13 words ▾

When using this product keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 8 words ▾

Stop use and ask doctor if rash occurs.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If product is swallowed, get medical help or call Poison Control Center right away.

📄 Other Information 16 words ▾

OTHER INFORMATION Other information: Protect the product in this container from excessive heat and direct sun.

📄 Package Label / Principal Display Panel 3 words ▾

Tube Tube1 carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 PEACH AND LILY SUN COVER MINERAL SUNSCREEN 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
2020 2022 2024 2026 272 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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 COSMAX USA. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
COSMAX USA 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.
← 68577-0297-00 · COSMAX 68577-0299-00 · COSMAX →
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.