THE ENERGIST Multi-Defense Broad Spectrum Sunscreen SPF 50 Zinc Oxide 21 g/100mL Cream, 60 packets
by Noble Panacea Labs, Inc. · 60 PACKET in 1 BOX (83637-150-16) / 1.1 mL in 1 PACKET
NDC 83637-0150-16
🏷️ FDA NDC (as labeled)
83637-150-16
billing pads the product segment with a zero
This package
Contains60 packets
Pack sizes3 compare ↓
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
83637-150-16
Product NDC
83637-150
11-digit billing NDC
83637015016
UNII
SOI2LOH54Z
Application #
M020
SPL Set ID
aed57f81-4b7d-42dc-993e-6bb10f93b02a
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2024-05-01
Route
TOPICAL
Dosage form
CREAM
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 83637-150-16 — 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 → 83637-0150-16. 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
LabelerNoble Panacea Labs, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83637
First marketedMay 2024
Product typeHuman Otc Drug
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?
THE ENERGIST Multi-Defense is a topical cream sunscreen containing zinc oxide as its active ingredient. This is an over-the-counter monograph product, meaning it is marketed under established FDA rules for sunscreen products rather than through an individual drug application. Zinc oxide functions as a broad-spectrum UV filter, typically used to help protect skin from ultraviolet rays. The product is labeled SPF 50 and is applied to the skin to reduce sun exposure.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about Zinc Oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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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.
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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.
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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 808T94CEU6
Arginine pyroglutamate is an amino acid salt combining arginine and pyroglutamic acid. It serves as a buffer and pH stabilizer in formulations, helping maintain the medicine's chemical stability and proper acidity level.
-
UNII 9K7IG15M0Q
Arthrospira maxima is a blue-green algae (spirulina) used as a natural colorant and nutritional ingredient in medicines. It adds blue-green color to tablets and capsules while providing vitamins and minerals.
-
UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid 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 1G1EAA320L
Celery seed is a plant-derived ingredient used as a flavoring agent and natural seasoning in medicines. It adds taste to make oral products more palatable for patients.
-
UNII 74ONU0S62G
A synthetic compound derived from amino acids and fatty acids. It acts as an emollient and skin-conditioning agent in topical formulations, helping to soften and smooth the product texture.
-
UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
-
UNII 8D9H4QU99H
A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
-
UNII J7IHY79BKY
A plant extract from glasswort, a coastal herb. It's used in formulations as a humectant to help retain moisture and may serve as a skin-conditioning agent in topical products.
-
UNII 7E6SK9QDT8
Cyclodextrins are ring-shaped sugar molecules derived from starch. They're used in medicines as solubilizers to help poorly dissolving drugs dissolve better, and sometimes as binders or stabilizers.
-
UNII ZGR06DO97T
Decyl oleate is a plant-derived oily liquid made by combining oleic acid with decyl alcohol. It serves as an emollient and solvent in medicines, helping to dissolve active ingredients and improve how the product spreads or absorbs through the skin.
-
UNII 89B2BSF9I3
A synthetic compound made by chemically combining corn dextrin (a starch derivative) with palmitic acid. It acts as a binder and flow agent, helping hold tablet ingredients together and improve powder handling during manufacturing.
-
UNII V51YH1B080
A synthetic antioxidant derived from lauric acid and thiopropionic acid. It prevents fats and oils in the medicine from breaking down or turning rancid during storage, helping maintain product stability and shelf life.
-
UNII 1F2S8T535O
A synthetic polymer made from fatty acids and a chemical compound that binds ingredients together. It works as a binder and film-former in solid dosage forms, helping hold tablets together and coat their surface.
-
UNII KT9IP8I17R
A synthetic polymer binder created by reacting isophorone diisocyanate with alcohols. It helps hold tablet or capsule ingredients together and may improve the product's stability and texture during manufacturing and storage.
-
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 EG3PA2K3K5
Ethylhexyl stearate is a waxy oil made from stearic acid and ethylhexyl alcohol. In medicines, it acts as an emollient and thickener to improve texture and help the product spread smoothly on skin or dissolve properly.
-
UNII AVM951ZWST
Ferulic acid is a naturally occurring plant compound used as an antioxidant in medications. It helps prevent ingredient breakdown and maintain product stability during storage.
-
UNII 4110YT348C
Flax seed is a plant-derived natural ingredient used as a binder and filler in medications. It helps hold tablet or capsule contents together and adds bulk to the formulation.
-
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 151Z7P1317
Hexyldecanol is a waxy alcohol derived from natural oils. It acts as an emollient and viscosity agent in topical formulations, helping create smooth texture and improve product spreadability on skin.
-
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 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 S870P55O2W
Isomalt is a sugar alcohol made from sugar that's used as a sweetener and bulking agent in medicines. It helps give tablets and powders the right texture and sweetness while having minimal calories.
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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.
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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.
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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.
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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.
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UNII TIX5482832
A plant-derived powder from moringa seeds, used in formulations as a natural binder and thickening agent to help hold ingredients together and achieve the desired texture or consistency.
-
UNII 8I63BQ3V64
A plant-derived ingredient from Nicotiana benthamiana (a relative of tobacco). It may serve as a natural binder or filler to help hold the tablet or capsule together and give it structure.
-
UNII 2A3916MQHO
A synthetic peptide derived from palm oil that functions as a skin-conditioning agent and emollient. In formulations, it helps soften and smooth the product texture while providing moisturizing properties to topical preparations.
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UNII 7Q50F46595
Pea protein is a plant-based powder extracted from peas. It's used as a binder and filler in tablets and capsules to hold ingredients together and add bulk to the formulation.
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UNII 50C1307PZG
Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
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UNII 598RES7AXX
A synthetic emulsifier derived from glycerin and oleic acid. It helps mix oil and water components in formulations, improving texture and stability of creams, lotions, or suspensions.
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UNII YPM0ZOC2HR
A synthetic emulsifier derived from glycerin and castor oil. It helps mix oil and water-based ingredients together in the formulation to create a uniform product and improve texture.
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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.
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UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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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.
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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.
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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 B46B6DD20U
Rapeseed sterol is a plant-derived fat obtained from rapeseed oil. It's used in medicines as an emulsifier and thickening agent to help blend oil and water-based ingredients and improve product texture.
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UNII W8K377W98I
A mixture of sugars made by rearranging glucose molecules. It acts as a sweetener and filler to improve taste and add bulk to the medicine while helping it hold together.
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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.
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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.
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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.
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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.
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UNII U16QOD6C4E
Sodium succinate hexahydrate is a salt form of succinic acid that contains water molecules. It functions as a buffer to help maintain stable pH levels in the medicine and may also act as a filler or tonicity agent.
-
UNII QE6F49RPJ1
A natural oil derived from sorbitol and oleic acid. It works as an emulsifier and solubilizer to help mix oil and water-based ingredients together and improve how the medicine dissolves or spreads in the body.
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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.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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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 2P6O7CFW5K
Triheptanoin is a synthetic fat made from glycerol and seven-carbon fatty acids. It's used as a caloric supplement and carrier in certain formulations to deliver active ingredients and provide nutritional support.
-
UNII 27N030R381
A plant-derived ingredient from mullein flowers, used as a natural flavoring agent or soothing additive in some medicinal formulations to enhance taste and texture.
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UNII ZLW3M94UYA
A natural extract from grape fruit cells, rich in tannins and polyphenols. Used in formulations as an antioxidant and preservative to help protect the product from degradation during storage.
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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.
59 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesWater/Eau/Aqua, Caprylic/Capric Triglyceride, Glycerin, Decyl Oleate, Ethylhexyl Stearate, Isododecane, Polyglyceryl-6 Polyricinoleate, Saccharide Isomerate, Propanediol, Silica, Aloe Barbadensis Leaf Juice, Hexyldecanol, Triheptanoin, Polyglyceryl-10 Dioleate, Disteardimonium Hectorite, Coco-Caprylate/Caprate, Polyhydroxystearic Acid, Arginine Pca, Squalane, Benzyl Alcohol, Dextrin Palmitate, Cyclodextrin, Isomalt, Hydrolyzed Verbascum Thapsus (Mullein) Flower, Hydrogenated Phospholipids, Dilinoleic Acid/Butanediol Copolymer, Hydroxyacetophenone, Allantoin, Sucrose, Citric Acid, Bisabolol, Tocopherol, Stearic Acid, Cetylhydroxyproline Palmitamide, Ferulic Acid, Sodium Chloride, Propylene Carbonate, Sorbitan Trioleate, Crithmum Maritimum (Sea Fennel) Extract, Spirulina Maxima Extract, Sodium Citrate, Castor Oil/Ipdi Copolymer, Lecithin, Palmitoyl Tripeptide-5, Brassica Campestris (Rapeseed) Sterols, Maltodextrin, Moringa Oleifera Seed Extract, Vitis Vinifera (Grape) Fruit Cell Extract, Potassium Sorbate, Glucose, Hydrolyzed Pea Protein, Apium Graveolens (Celery) Seed Extract, Linum Usitatissimum (Linseed) Seed Extract, Pentylene Glycol, Caprylyl Glycol, Dilauryl Thiodipropionate, Sodium Succinate, Nicotiana Benthamiana Hexapeptide-40 sh-Polypeptide-47, Potassium Hydroxide, Sodium Benzoate.
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 system | Per g | Per 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lather- Daily Defense Mineral Spf 50 Body Sunscreen 21 g/100mL 77394-0203-03 | Lather, | 88 ml | — | — | FDA listed | — |
| THE ENERGIST Multi-Defense Broad Spectrum Sunscreen SPF 50 21 g/100mLthis 83637-0150-16 | Noble | 60 packets | — | — | 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
May 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.
🔬 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 THE ENERGIST Multi-Defense Broad Spectrum Sunscreen SPF 50 (this brand).
Top reported reactions
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 83637-0150-12 | 60 PACKET in 1 BOX (83637-150-12) / 1.1 mL in 1 PACKET | 2024-05-01 | Active |
| 83637-0150-14 | 1 PACKET in 1 BOX (83637-150-14) / 1.1 mL in 1 PACKET | 2024-05-01 | Active |
| 83637-0150-16 You're viewing this | 60 PACKET in 1 BOX (83637-150-16) / 1.1 mL in 1 PACKET | 2024-05-01 | Active |
Pack size FAQ
What quantity is in NDC 83637-0150-16?
NDC 83637-0150-16 contains 60 packets — 60 packet in 1 box / 1.1 ml in 1 packet.
What is the difference between NDC 83637-0150-16 and NDC 83637-0150-14?
Both are THE ENERGIST Multi-Defense Broad Spectrum Sunscreen SPF 50 Zinc Oxide 21 g/100mL Cream — the drug itself is identical. NDC 83637-0150-16 is the 60 packets package, while NDC 83637-0150-14 is the 1 packet package.
What NDC number is used to bill for this package of THE ENERGIST Multi-Defense Broad Spectrum Sunscreen SPF 50 Zinc Oxide 21 g/100mL Cream?
Bill NDC 83637-0150-16 — the 11-digit billing format is 83637015016. 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 83637-150-16, 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: 83637-0150-16, written without dashes as 83637015016. 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 83637-0150-16, the first segment (83637) is the labeler code FDA assigned to Noble Panacea Labs, Inc.; the middle segment (0150) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) 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 Noble Panacea Labs, 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 2 other package presentations of this same product, including 1 packet (83637-0150-14), 60 packets (83637-0150-12). 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?
Noble Panacea Labs, 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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
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 ▾
Directions • apply liberally 15 minutes before sun exposure • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • children under 6 months of age: Ask a doctor
⚠️ Warnings ▾
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 a doctor if rash occurs Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away
📦 Storage and Handling ▾
Other information Protect the product in this container from excessive heat and direct sun
🧪 Active Ingredient ▾
Active ingredient Zinc Oxide 21.0%
🧪 Inactive Ingredients ▾
Inactive ingredients Water/Eau/Aqua, Caprylic/Capric Triglyceride, Glycerin, Decyl Oleate, Ethylhexyl Stearate, Isododecane, Polyglyceryl-6 Polyricinoleate, Saccharide Isomerate, Propanediol, Silica, Aloe Barbadensis Leaf Juice, Hexyldecanol, Triheptanoin, Polyglyceryl-10 Dioleate, Disteardimonium Hectorite, Coco-Caprylate/Caprate, Polyhydroxystearic Acid, Arginine Pca, Squalane, Benzyl Alcohol, Dextrin Palmitate, Cyclodextrin, Isomalt, Hydrolyzed Verbascum Thapsus (Mullein) Flower, Hydrogenated Phospholipids, Dilinoleic Acid/Butanediol Copolymer, Hydroxyacetophenone, Allantoin, Sucrose, Citric Acid, Bisabolol, Tocopherol, Stearic Acid, Cetylhydroxyproline Palmitamide, Ferulic Acid, Sodium Chloride, Propylene Carbonate, Sorbitan Trioleate, Crithmum Maritimum (Sea Fennel) Extract, Spirulina Maxima Extract, Sodium Citrate, Castor Oil/Ipdi Copolymer, Lecithin, Palmitoyl Tripeptide-5, Brassica Campestris (Rapeseed) Sterols, Maltodextrin, Moringa Oleifera Seed Extract, Vitis Vinifera (Grape) Fruit Cell Extract, Potassium Sorbate, Glucose, Hydrolyzed Pea Protein, Apium Graveolens (Celery) Seed Extract, Linum Usitatissimum (Linseed) Seed Extract, Pentylene Glycol, Caprylyl Glycol, Dilauryl Thiodipropionate, Sodium Succinate, Nicotiana Benthamiana Hexapeptide-40 sh-Polypeptide-47, Potassium Hydroxide, Sodium Benzoate.
🎯 Purpose ▾
Purpose Sunscreen
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Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
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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.