HomeNDC LookupIngredientsOctinoxate, Zinc Oxide › 14141-0328-01
LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 BEIGE 220-C OCTINOXATE, ZINC OXIDE 60 mg/mL; 29.4 mg/mL Emulsion — NDC 14141-0328-01 package photo

LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 BEIGE 220-C OCTINOXATE, ZINC OXIDE 60 mg/mL; 29.4 mg/mL Emulsion

by BEL STAR SA · 1 BOTTLE, GLASS in 1 BOX (14141-328-01) / 26 mL in 1 BOTTLE, GLASS
NDC 14141-0328-01
🏷️ FDA NDC (as labeled) 14141-328-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 14141-328-01
Product NDC 14141-328
11-digit billing NDC 14141032801
UNII 4Y5P7MUD51, SOI2LOH54Z
Application # M020
SPL Set ID f9266687-73d2-dac9-e053-6394a90ac2a1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-04-19
Route TOPICAL
Dosage form EMULSION
Substance OCTINOXATE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 14141-328-01 — 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 → 14141-0328-01. 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

LabelerBEL STAR SA
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code14141
First marketedApr 2023
Product typeHuman Otc Drug
Portfolio19 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 emulsion sunscreen and anti-aging serum marketed under the over-the-counter monograph rules. It contains octinoxate and zinc oxide, which are ultraviolet light filters commonly used in sunscreens to help protect skin from sun damage. The product is formulated as a foundation with an SPF 15 rating and is designed to be applied to the face.

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 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 2936P60TPX
    A plant extract from baobab tree seeds used as a natural thickener and emulsifier in medicines. It helps create the right texture and keeps ingredients mixed together in liquid or semi-solid formulations.
  • UNII 0J9G6W44DV
    A plant extract from the bark of the silk tree, used as a natural binding and thickening agent in some formulations to help hold ingredients together and add consistency to the medicine.
  • 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 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 5ET1T25H82
    A protein component derived from rice that serves as a binder and filler in medications. It helps hold tablet ingredients together and adds bulk to the formulation.
  • UNII MLM29U2X85
    Calcium citrate is a salt derived from citric acid and calcium. It acts as a buffer to stabilize the medicine's pH, a filler to add bulk, and sometimes a source of calcium in the formulation.
  • 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 V2W71V8T0X
    A silicone-based compound that mixes oil and water together. Used in formulations as an emulsifier to help blend ingredients and improve texture and stability of creams, lotions, and other topical products.
  • UNII I670DAL4SZ
    A preservative that fights bacteria and fungi. It keeps medicines and topical products stable and safe from microbial contamination during storage and use.
  • UNII 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • UNII XHK3U310BA
    Cyclohexasiloxane is a silicon-based liquid that acts as a solvent and conditioning agent in medicines. It helps dissolve or carry other ingredients and improves how the product spreads or feels on the skin.
  • UNII 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout 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 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 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 WB5K9Y35Y9
    A synthetic crosslinked polymer made by combining hexamethylene diisocyanate with trimethylol hexyllactone. It's used as a film-former and binder to help create protective coatings on tablets or capsules and improve product stability.
  • UNII 4CG9F9W01Q
    A synthetic fatty acid ester used as an emollient and skin-conditioning agent in topical medicines. It helps soften the product texture and improves how it spreads and absorbs into the skin.
  • 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 1394NXB9L6
    A plant-derived protein from soybeans that has been broken down into smaller pieces using enzymes. It acts as a binder and texture agent, helping hold ingredients together and improve the product's consistency and mouthfeel.
  • UNII MBQ7DDQ7AR
    Hydroxyethyl urea is a synthetic organic compound used in medicines as a humectant and conditioning agent. It helps retain moisture in formulations and may improve texture or stability in topical products.
  • UNII A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • UNII OAH19558U1
    A synthetic compound made from coconut oil, laureth-12 helps mix oil and water-based ingredients together. It acts as an emulsifier and surfactant in formulations, improving how the medicine spreads and is absorbed.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII A1U5YJI0Z8
    A mushroom extract used as a filler and nutritional ingredient in supplements and some medications. It adds bulk to the formulation and may provide texture or consistency to the final product.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII N8F53B3R4R
    A synthetic humectant and solvent derived from propane. It draws and holds moisture in the formulation, helping keep the medicine stable and improving texture or flow in liquid and semi-solid products.
  • 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 446U8J075B
    Nylon-12 is a synthetic plastic polymer used as a coating or film-forming agent in medicines. It helps create a protective barrier around tablets or capsules to control how and when the medicine is released in the body.
  • 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 287GF3Y3WC
    PEG-10 Dimethicone is a silicone-based compound that acts as an emulsifier and surfactant in medicines. It helps blend water and oil-based ingredients together and reduces surface tension to improve how the product spreads and feels.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 820DPX33S7
    A synthetic emulsifier derived from glycerin and fatty acids. It helps mix oil and water-based ingredients together and keeps them evenly blended throughout the product.
  • UNII 59Z907ZB69
    A synthetic silicone polymer used as a glidant and anti-caking agent. It reduces friction between particles, helping powders and tablets flow smoothly during manufacturing and use.
  • UNII X2PZH4Y6HT
    A silicone-based powder derived from silicon and oxygen compounds. It works as a glidant and anti-caking agent to improve how the tablet or capsule flows during manufacturing and prevent clumping in the finished product.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 9DLQ4CIU6V
    Proline is an amino acid used in pharmaceutical formulations as a bulking agent and stabilizer. It helps maintain product stability and can improve the texture or consistency of medicines, particularly in powders and freeze-dried products.
  • 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 C054DF30K0
    A silicone-based compound that acts as a glidant and anti-caking agent in solid medicines. It helps powder particles flow smoothly during manufacturing and prevents clumping in the final product.
  • UNII EU2PSP0G0W
    Silica dimethyl silylate is a silicon-based powder that acts as a glidant and anti-caking agent. It reduces friction between particles and helps powders flow smoothly during manufacturing and tablet compression.
  • 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 C269C4G2ZQ
    Sodium alginate is a natural thickener and gelling agent derived from seaweed. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust texture, and a disintegrant to help the tablet or capsule break apart for absorption.
  • 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 469OTG57A2
    Sodium pyrrolidone carboxylate is a synthetic polymer derived from pyrrolidone chemistry. It functions as a solubilizer and binder in medications, helping dissolve poorly water-soluble drugs and hold tablet ingredients together.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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 25LXE464L2
    A silicone-based polymer used as a glidant and anti-caking agent in solid dosage forms. It reduces friction between particles and prevents clumping, helping powders flow smoothly during manufacturing and tablet compression.
  • UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
  • UNII 1D1K0N0VVC
    A fat-soluble form of vitamin A used as a colorant and nutritional fortification ingredient. It gives products a yellow or orange tint and increases vitamin A content in the formula.
  • 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.

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

The official label also statesWATER, CYCLOHEXASILOXANE, ISODODECANE, GLYCERIN, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, ALCOHOL DENAT., NYLON-12, NIACINAMIDE, HYDROXYETHYL UREA, PEG-10 DIMETHICONE, TRIMETHYLSILOXYSILICATE, CETYL PEG/PPG-10/1 DIMETHICONE, POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE, SODIUM PCA, POLYMETHYLSILSESQUIOXANE, ALBIZIA JULIBRISSIN BARK EXTRACT, SILICA, POLYSILICONE-11, PHENOXYETHANOL, CYCLOPENTASILOXANE, POLYGLYCERYL-4 ISOSTEARATE, TOCOPHERYL ACETATE, HEXYL LAURATE, SILICA DIMETHYL SILYLATE, METHYLPROPANEDIOL, CAPRYLYL GLYCOL, DISTEARDIMONIUM HECTORITE, CHLORPHENESIN, SILANEDIOL SALICYLATE, FRAGRANCE, RETINYL PALMITATE, ALCOHOL, TROMETHAMINE, ACACIA SENEGAL GUM EXTRACT, PANTHENOL, PROPANEDIOL, CERAMIDE NP, LECITHIN, GRIFOLA FRONDOSA FRUITING BODY EXTRACT, MALTODEXTRIN, HYDROLYZED SOY PROTEIN, POTASSIUM SORBATE, SODIUM BENZOATE, LAURETH-12, RICE AMINO ACIDS, PROLINE, ALGIN, HYALURONIC ACID, SODIUM HYALURONATE, HYDROLYZED ADANSONIA DIGITATA SEED EXTRACT, CALCIUM CITRATE, ETHYLHEXYLGLYCERIN. MAY CONTAIN: TITANIUM DIOXIDE, IRON OXIDES, TRIETHOXYCAPRYLYLSILANE.

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 mLPer 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
Lbel Concentre Base Serum Antiedad Efecto Lifting Fps 15 Anti Aging Lifting Serum Foundation Spf 15 Capuccino 310-C 60 mg/mL; 29.4 mg/mL 14141-0330-01 BEL 1 bottle FDA listed
Lbel Concentre Global Anti Aging Serum Foundation Spf 15 Almendra 230N 60 mg/mL; 29.4 mg/mL 14141-0371-01 BEL 1 jar FDA listed
Lbel Solutions Pro-Nude Skin Ultra-Light Serum Foundation With Niacinamide Spf 20 Almendra 230N 60 mg/mL; 29.4 mg/mL 14141-0380-01 BEL 1 bottle FDA listed
Lbel Concentre Base Serum Antiedad Efecto Lifting Fps 15 Anti Aging Lifting Serum Foundation Spf 15 Beige 220-C 60 mg/mL; 29.4 mg/mLthis 14141-0328-01 BEL 1 bottle FDA listed
Lbel Solutions Pro-Nude Skin Ultra-Light Serum Foundation With Niacinamide Spf 20 Beige 220C 60 mg/mL; 29.4 mg/mL 14141-0379-01 BEL 1 bottle FDA listed
Lbel Nude Skin Ultra Light Matte Foundation With Vitamins Spf 20 Capuccino 310-C 60 mg/mL; 29.4 mg/mL 14141-0019-01 Bel 1 bottle FDA listed
Lbel Concentre Base Serum Antiedad Efecto Lifting Fps 15 Anti Aging Lifting Serum Foundation Spf 15 Latte 180-F 60 mg/mL; 29.4 mg/mL 14141-0327-01 BEL 1 bottle FDA listed
Lbel Concentre Base Serum Antiedad Efecto Lifting Fps 15 Anti Aging Lifting Serum Foundation Spf 15 Almendra 230-N 60 mg/mL; 29.4 mg/mL 14141-0329-01 BEL 1 bottle FDA listed
Lbel Concentre Global Anti Aging Serum Foundation Spf 15 Latte 180F 60 mg/mL; 29.4 mg/mL 14141-0375-01 BEL 1 jar FDA listed
Lbel Concentre Global Anti Aging Serum Foundation Spf 15 Capuccino 310C 60 mg/mL; 29.4 mg/mL 14141-0373-01 BEL 1 jar FDA listed
Lbel Nude Skin Ultra Light Matte Foundation With Vitamins Spf 20 Almendra 230-N 60 mg/mL; 29.4 mg/mL 14141-0017-01 Bel 1 bottle FDA listed
Lbel Concentre Base Serum Antiedad Efecto Lifting Fps 15 Anti Aging Lifting Serum Foundation Spf 15 Champagne 170-N 60 mg/mL; 29.4 mg/mL 14141-0326-01 BEL 1 bottle FDA listed
Lbel Solutions Pro-Nude Skin Ultra-Light Serum Foundation With Niacinamide Spf 20 Latte 180F 60 mg/mL; 29.4 mg/mL 14141-0378-01 BEL 1 bottle FDA listed
Lbel Nude Skin Ultra Light Matte Foundation With Vitamins Spf 20 Beige 220-C 60 mg/mL; 29.4 mg/mL 14141-0018-01 Bel 1 bottle FDA listed
Lbel Concentre Global Anti Aging Serum Foundation Spf 15 Champagne 170N 60 mg/mL; 29.4 mg/mL 14141-0374-01 BEL 1 jar FDA listed
Lbel Solutions Pro-Nude Skin Ultra-Light Serum Foundation With Niacinamide Spf 20 Champagne 170N 60 mg/mL; 29.4 mg/mL 14141-0377-01 BEL 1 bottle FDA listed
Lbel Solutions Pro-Nude Skin Ultra-Light Serum Foundation With Niacinamide Spf 20 Capuccino 310C 60 mg/mL; 29.4 mg/mL 14141-0381-01 BEL 1 bottle FDA listed
Lbel Nude Skin Ultra Light Matte Foundation With Vitamins Spf 20 Mokaccino 390-N 60 mg/mL; 29.4 mg/mL 14141-0022-01 Bel 1 bottle FDA listed
Lbel Nude Skin Ultra Light Matte Foundation With Vitamins Spf 20 Champagne 170-N 60 mg/mL; 29.4 mg/mL 14141-0020-01 Bel 1 bottle FDA listed
Lbel Nude Skin Ultra Light Matte Foundation With Vitamins Spf 20 Latte 180-F 60 mg/mL; 29.4 mg/mL 14141-0021-01 Bel 1 bottle FDA listed
Lbel Concentre Global Anti Aging Serum Foundation Spf 15 Beige 220C 60 mg/mL; 29.4 mg/mL 14141-0372-01 BEL 1 jar FDA listed
Lbel Solutions Pro Nude Skin Base Serum Tint Cobertura Antimanchas Fps 15 Anti Dark Spot Coverage Serum Tint Foundation Spf 15 Champagne 170-N 60 mg/mL; 29.4 mg/mL 14141-0587-01 BEL 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

🏛️
2023
On the market since
Apr 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for OCTINOXATE, ZINC OXIDE — the ingredient across all brands.

Top reported reactions

Application Site Erythema2
Application Site Swelling2
Pruritus2
Skin Exfoliation2
Urticaria2
Anaphylactic Shock1
Application Site Burn1

Age at onset

Adult1

Reporter sex

8 reports
Female · 100%

Serious outcomes

Hospitalization1
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 1 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
14141-0328-01 You're viewing this 1 BOTTLE, GLASS in 1 BOX (14141-328-01) / 26 mL in 1 BOTTLE, GLASS 2023-04-19 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 14141-328-01, 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: 14141-0328-01, written without dashes as 14141032801. 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 14141-0328-01, the first segment (14141) is the labeler code FDA assigned to BEL STAR SA; the middle segment (0328) 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 BEL STAR SA. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
BEL STAR SA 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 4 words

Uses Helps prevent sunburn.

⏱️ Dosage and Administration 34 words

Directions Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor

⚠️ Warnings 90 words

Warnings Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. 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 a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 7 words

Active Ingredients OCTINOXATE 6.00% ZINC OXIDE 2.94%

🧪 Inactive Ingredients 103 words

Inactive ingredients WATER, CYCLOHEXASILOXANE, ISODODECANE, GLYCERIN, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, ALCOHOL DENAT., NYLON-12, NIACINAMIDE, HYDROXYETHYL UREA, PEG-10 DIMETHICONE, TRIMETHYLSILOXYSILICATE, CETYL PEG/PPG-10/1 DIMETHICONE, POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE, SODIUM PCA, POLYMETHYLSILSESQUIOXANE, ALBIZIA JULIBRISSIN BARK EXTRACT, SILICA, POLYSILICONE-11, PHENOXYETHANOL, CYCLOPENTASILOXANE, POLYGLYCERYL-4 ISOSTEARATE, TOCOPHERYL ACETATE, HEXYL LAURATE, SILICA DIMETHYL SILYLATE, METHYLPROPANEDIOL, CAPRYLYL GLYCOL, DISTEARDIMONIUM HECTORITE, CHLORPHENESIN, SILANEDIOL SALICYLATE, FRAGRANCE, RETINYL PALMITATE, ALCOHOL, TROMETHAMINE, ACACIA SENEGAL GUM EXTRACT, PANTHENOL, PROPANEDIOL, CERAMIDE NP, LECITHIN, GRIFOLA FRONDOSA FRUITING BODY EXTRACT, MALTODEXTRIN, HYDROLYZED SOY PROTEIN, POTASSIUM SORBATE, SODIUM BENZOATE, LAURETH-12, RICE AMINO ACIDS, PROLINE, ALGIN, HYALURONIC ACID, SODIUM HYALURONATE, HYDROLYZED ADANSONIA DIGITATA SEED EXTRACT, CALCIUM CITRATE, ETHYLHEXYLGLYCERIN.

MAY CONTAIN : TITANIUM DIOXIDE, IRON OXIDES, TRIETHOXYCAPRYLYLSILANE.

🎯 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.