Home › NDC Lookup › Ingredients › Zinc Oxide, Titanium Dioxide, Octinoxate... › 83154-0004-04
ELROEL Pang Pang Sun Cushion Plus Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate 1.52 g/100g; 9.7 g/100g; 7 g/100g; 3 g/100g Cream, 8 g — NDC 83154-0004-04 package photo

ELROEL Pang Pang Sun Cushion Plus Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate 1.52 g/100g; 9.7 g/100g; 7 g/100g; 3 g/100g Cream, 8 g

by MONOGLOT HOLDINGS Inc. · 1 CONTAINER in 1 CARTON (83154-004-04) / 8 g in 1 CONTAINER (83154-004-03)
NDC 83154-0004-04
🏷️ FDA NDC (as labeled) 83154-004-04 billing pads the product segment with a zero
This package
Contains8 g Pack sizes5 compare ↓
Also comes in: 15 g 83154-0004-08 25 g 83154-0004-10 15 g 83154-0004-02 25 g 83154-0004-06
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 83154-004-04
Product NDC 83154-004
11-digit billing NDC 83154000404
UNII 15FIX9V2JP, SOI2LOH54Z, 4Y5P7MUD51, 4X49Y0596W
Application # M020
SPL Set ID 5ffaad65-f0b2-416a-b0a3-b92e880641e4
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 2024-02-03
Route TOPICAL
Dosage form CREAM
Substance TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE; OCTISALATE
Why two NDCs? The FDA registers this code as 83154-004-04 — 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 → 83154-0004-04. 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

LabelerMONOGLOT HOLDINGS Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83154
First marketedFeb 2024
Product typeHuman Otc Drug
Portfolio2 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 cream sunscreen marketed as an over-the-counter monograph product. It contains four active ingredients that work together to filter and reflect ultraviolet (UV) rays from the sun. Octinoxate and octisalate are chemical UV filters that absorb UV radiation, while zinc oxide and titanium dioxide are mineral UV filters that reflect and scatter UV light. Products with this combination are typically used to help protect skin from sun exposure.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 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 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 K72T3FS567
    Adenosine is a naturally occurring nucleoside compound. In medicines, it functions as an active pharmaceutical ingredient in some formulations, though when listed as an excipient it may serve as a buffering or stabilizing agent to maintain product stability and pH.
  • 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 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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII 376KTP06K8
    Amiloxate is a synthetic compound used as an ultraviolet light absorber in topical formulations. It helps protect the medicine from degradation caused by sunlight exposure during storage and use.
  • UNII 5SL0G7R0OK
    A simple sugar made from corn or other plants, used in medicines as a filler and sweetener. It helps create the right texture and taste in tablets, powders, and liquid formulations.
  • 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 9PA5A687X5
    Asiatic acid is a natural compound extracted from plants that acts as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product's texture while supporting skin hydration.
  • UNII PKO39VY215
    A natural compound derived from Centella asiatica plant, used as an active botanical extract or skin-conditioning agent in topical formulations to support ingredient stability and product efficacy.
  • 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 568ET80C3D
    Calcium pantothenate is a salt form of pantothenic acid, a B-vitamin derivative. It's used as a nutritional supplement or vitamin fortification ingredient in medicines and formulations.
  • 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 Q95M2P1KJL
    A silicone-based ingredient that acts as a lubricant and glidant. It helps the tablet or capsule move smoothly through manufacturing equipment and improves powder flow during production.
  • 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 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 8INO2K35FA
    A silicone-based compound that mixes oil and water components together. It acts as an emulsifier and helps distribute ingredients evenly throughout the formulation, improving texture and stability.
  • 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 ANQ870JD20
    A synthetic chemical compound used as a UV filter in topical formulations. It protects the medicine or product from degradation caused by sunlight exposure during storage and use.
  • UNII I43FCF3356
    A plant extract from Japanese yam root used as a natural binder and thickening agent. It helps hold tablet ingredients together and adds consistency to the formulation.
  • UNII I445L28B12
    A silicone-based compound that acts as a lubricant and glidant in tablet and capsule formulations. It reduces friction between particles and on equipment surfaces, helping medicines flow smoothly during manufacturing and tablet compression.
  • 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 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • UNII 6S7S02945H
    A synthetic compound derived from menthol, ethyl menthane carboxamide is used as a flavoring agent and sensory enhancer in medicines to improve taste and provide a cooling or soothing sensation.
  • 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 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 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII CA2Y0FE3FX
    A salt derived from licorice root extract, used as a flavoring agent and sweetener. It may also help soothe and protect mucous membranes in throat lozenges and cough products.
  • 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 WE98HW412B
    A seaweed-derived ingredient from Japanese kelp. It acts as a thickener and binder in medications, helping create the proper texture and hold the formula together.
  • UNII M7O1N24J82
    Madecassic acid is a natural compound extracted from Centella asiatica plant. In medications, it acts as an active pharmaceutical ingredient or functional excipient that may support skin health and wound healing in topical formulations.
  • UNII CQ2F5O6YIY
    A natural compound extracted from Centella asiatica plant used as an active skin-conditioning ingredient. It functions as a humectant and skin protectant to improve moisture retention and support skin barrier function in topical formulations.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 2BF9E65L7I
    A chemical compound combining menthol with lactic acid. It's used in medicines as a flavoring agent and to provide a cooling or soothing sensation on the skin or mouth.
  • UNII 6QOP5A9489
    A synthetic organic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and improve their absorption through the skin.
  • 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 YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII ML9LGA7468
    A naturally-derived alcohol used as a preservative and fragrance in medicines. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • 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 581437HWX2
    A synthetic oily liquid made from propylene glycol and fatty acids. It works as an emollient and solubilizer in medicines, helping dissolve active ingredients and improve how the product spreads or absorbs.
  • UNII 68Y4CF58BV
    Pyridoxine hydrochloride is a form of vitamin B6, added to medicines as a nutritional supplement or to meet dietary requirements. It supports the body's metabolism and nerve function.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII 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 836SJG51DR
    Sodium ascorbyl phosphate is a derivative of vitamin C that acts as an antioxidant and preservative in medications. It helps protect the drug's active ingredients from degradation caused by air and light exposure.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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 31Q9363QSX
    A silicone-free conditioning agent derived from fatty acids and dimethylamine. Used in formulations as a thickener, emulsifier, and to improve texture and spreadability of topical products.
  • UNII 274KW0O50M
    Sucrose stearate is a compound made from sugar and stearic acid (a fatty substance). It works as an emulsifier and surfactant to help mix oils and water-based ingredients together in the medicine.
  • UNII 08MNR5YE2R
    A wax made in a laboratory to mimic natural beeswax. It's used as a coating, binder, and thickener to give medicines a smooth texture and protect them from moisture.
  • 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 URQ79U8261
    A plant extract from the root of the Ulmus davidiana tree. It functions as a binder and thickening agent to help hold the medicine together and improve its texture and consistency.
  • UNII 9NH1UDD2RR
    A synthetic silicone polymer that forms a smooth, water-resistant film. Used in topical formulations as a skin protectant coating and to improve product texture and spreadability on the skin.
  • UNII 46MR945M6X
    A plant-derived ingredient made from Viola mandshurica flowers, used primarily as a coloring agent, flavor enhancer, or botanical extract in the formulation.
  • 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 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.
  • UNII 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

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

The official label also statesAloe Barbadensis Leaf JuiceCyclopentasiloxane, Butylene Glycol, Butyloctyl Salicylate, Caprylyl Methicone, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Niacinamide, Diphenylsiloxy Phenyl Trimethicone, Alcohol Denat., Propylene Glycol Dicaprylate, Sodium Chloride, Silica, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hydroxyacetophenone, Synthetic Beeswax, Disteardimonium Hectorite, Triethoxycaprylylsilane, Dipropylene Glycol, Water, Fragrance, Caprylyl Glycol, Squalane, Tocopheryl Acetate, Propylene Carbonate, Ethylhexylglycerin, Glycerin, Adenosine, Butyrospermum Parkii (Shea) Butter, Xylitylglucoside, Anhydroxylitol, Disodium EDTA, Methyl Diisopropyl Propionamide, Laminaria Japonica Extract, Ulmus Davidiana Root Extract, Aloe Barbadensis Leaf Extract, Viola Mandshurica Flower Extract, Dioscorea Japonica Root Extract, Xylitol, CI 77492, 1,2-Hexanediol, Glucose, Menthyl Lactate, Beeswax, Ethyl Menthane Carboxamide, Glyceryl Stearate, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Calcium Pantothenate, Centella Asiatica Extract, Sucrose Stearate, Stearamidopropyl Dimethylamine Lactate, Phenethyl Alcohol, PEG-100 Stearate, Sodium Ascorbyl Phosphate, Dipotassium Glycyrrhizate, Cetearyl Alcohol, Polyquaternium-67, Pyridoxine HCl, Madecassoside, Madecassic Acid, Asiaticoside, Asiatic Acid

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.
Try another pack size: 15 g 25 g 15 g 25 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
ELROEL Pang Pang Sun Cushion Plus 1.52 g/100g; 9.7 g/100g; 7 g/100g; 3 g/100gthis 83154-0004-04 MONOGLOT 8 g — — FDA listed —
ELROEL Pang Pang Sun Cushion S7 1.52 g/100g; 9.7 g/100g; 7 g/100g; 3 g/100g 83154-0003-02 MONOGLOT 25 g — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2024
On the market since
Feb 2024
📍
2026
Currently FDA-listed
2 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
83154-0004-02 1 CONTAINER in 1 CARTON (83154-004-02) / 15 g in 1 CONTAINER (83154-004-01) 2024-02-03 Active
83154-0004-04 You're viewing this 1 CONTAINER in 1 CARTON (83154-004-04) / 8 g in 1 CONTAINER (83154-004-03) 2025-01-20 Active
83154-0004-06 1 CONTAINER in 1 CARTON (83154-004-06) / 25 g in 1 CONTAINER (83154-004-05) 2025-01-20 Active
83154-0004-08 1 CONTAINER in 1 POUCH (83154-004-08) / 15 g in 1 CONTAINER (83154-004-07) 2025-09-18 Active
83154-0004-10 1 CONTAINER in 1 POUCH (83154-004-10) / 25 g in 1 CONTAINER (83154-004-09) 2025-09-18 Active

Pack size FAQ

What quantity is in NDC 83154-0004-04?
NDC 83154-0004-04 contains 8 g — 1 container in 1 carton / 8 g in 1 container.
What is the difference between NDC 83154-0004-04 and NDC 83154-0004-02?
Both are ELROEL Pang Pang Sun Cushion Plus Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate 1.52 g/100g; 9.7 g/100g; 7 g/100g; 3 g/100g Cream — the drug itself is identical. NDC 83154-0004-04 is the 8 g package, while NDC 83154-0004-02 is the 15 g package.
What NDC number is used to bill for this package of ELROEL Pang Pang Sun Cushion Plus Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate 1.52 g/100g; 9.7 g/100g; 7 g/100g; 3 g/100g Cream?
Bill NDC 83154-0004-04 — the 11-digit billing format is 83154000404. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ 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 83154-004-04, 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: 83154-0004-04, written without dashes as 83154000404. 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 83154-0004-04, the first segment (83154) is the labeler code FDA assigned to MONOGLOT HOLDINGS Inc.; the middle segment (0004) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 MONOGLOT HOLDINGS Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 1 pouch (83154-0004-08), 1 pouch (83154-0004-10), 15 g (83154-0004-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
MONOGLOT HOLDINGS Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ 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), decreases the risk of skin cancer and early skin aging caused by the sun.

⏱️ Dosage and Administration 103 words ▾

- Apply liberally 15 minutes before sun exposure. - Reapply: - after 80 minutes of swimming or sweating - immediately after towel drying - at least every 2 hours - Sun protection measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: 1) Limit time in the sun, especially from 10 a.m. to 2 p.m. 2) Wear long-sleeved shirts, pants, hats, and sunglasses - Children under 6 months of age: Ask a doctor.

⚠️ 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 10 words ▾

ZINC OXIDE 9.70% OCTINOXATE 7.00% OCTISALATE 3.00% TITANIUM DIOXIDE 1.52%

🧪 Inactive Ingredients 131 words ▾

Aloe Barbadensis Leaf JuiceCyclopentasiloxane, Butylene Glycol, Butyloctyl Salicylate, Caprylyl Methicone, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Niacinamide, Diphenylsiloxy Phenyl Trimethicone, Alcohol Denat., Propylene Glycol Dicaprylate, Sodium Chloride, Silica, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hydroxyacetophenone, Synthetic Beeswax, Disteardimonium Hectorite, Triethoxycaprylylsilane, Dipropylene Glycol, Water, Fragrance, Caprylyl Glycol, Squalane, Tocopheryl Acetate, Propylene Carbonate, Ethylhexylglycerin, Glycerin, Adenosine, Butyrospermum Parkii (Shea) Butter, Xylitylglucoside, Anhydroxylitol, Disodium EDTA, Methyl Diisopropyl Propionamide, Laminaria Japonica Extract, Ulmus Davidiana Root Extract, Aloe Barbadensis Leaf Extract, Viola Mandshurica Flower Extract, Dioscorea Japonica Root Extract, Xylitol, CI 77492, 1,2-Hexanediol, Glucose, Menthyl Lactate, Beeswax, Ethyl Menthane Carboxamide, Glyceryl Stearate, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Calcium Pantothenate, Centella Asiatica Extract, Sucrose Stearate, Stearamidopropyl Dimethylamine Lactate, Phenethyl Alcohol, PEG-100 Stearate, Sodium Ascorbyl Phosphate, Dipotassium Glycyrrhizate, Cetearyl Alcohol, Polyquaternium-67, Pyridoxine HCl, Madecassoside, Madecassic Acid, Asiaticoside, Asiatic Acid

🎯 Purpose 1 words ▾

Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 83154-0003-02 · MONOGLOT 83157-0371-09 · Lotte →
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.