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Dr Edward Krulig New Melan Sunblock SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE 30 mg/mL; 50 mg/mL; 100 mg/mL Liquid, 100 mL — NDC 84857-545-00 (Billing 84857-0545-00)

by KRULIG INTERNATIONAL, INC · 100 mL in 1 BOTTLE

This is a package of 100 mL of Dr Edward Krulig New Melan Sunblock SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE 30 mg/mL; 50 mg/mL; 100 mg/mL Liquid from KRULIG INTERNATIONAL, INC, marketed since Oct 2024 and currently FDA-listed. It is this product's only package size.

NDC 84857-0545-00
🏷️ FDA NDC (as labeled) 84857-545-00 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84857-545-00
Product NDC 84857-545
11-digit billing NDC 84857054500
UNII G63QQF2NOX, 4X49Y0596W, 5A68WGF6WM
Application # M020
SPL Set ID 21c301d2-b283-40e1-bf26-b4bdde278247
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-10-14
Route TOPICAL
Dosage form LIQUID
Substance AVOBENZONE; OCTISALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 84857-545-00 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 84857-0545-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

🧪 What is this product?

Dr Edward Krulig New Melan Sunblock SPF 50 is a topical liquid sunscreen marketed as an over-the-counter monograph product. It contains three active UV-filtering ingredients: avobenzone, octisalate, and octocrylene, which are typically used together to absorb and scatter ultraviolet radiation from the sun. This combination of chemical and physical sunscreen agents is commonly formulated into protective lotions and creams designed to be applied to the skin.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
84857-0545-00 You're viewing this Main listing 100 mL in 1 BOTTLE 2024-10-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
California Mango Spf-50 Sunscreen 30 mg/mL; 50 mg/mL; 100 mg/mL 83453-0406-00 CALMANGO, 177 ml — — FDA listed —
SunPlus SPF 50 Everyday Inspired Broad Spectrum Sunscreen 30 mg/mL; 50 mg/mL; 100 mg/mL 84661-0523-00 SUNPLUS 177 ml — — FDA listed —
SunPlus Healthy Skin Sunny Living SPF 50 Mist Sunscreen 30 mg/mL; 50 mg/mL; 100 mg/mL 84661-0951-00 SUNPLUS 177 ml — — FDA listed —
SunPlus Healthy Skin Sunny Living SPF 30 Mist Sunscreen 30 mg/mL; 50 mg/mL; 100 mg/mL 84661-0952-00 SUNPLUS 177 ml — — FDA listed —
Dr Edward Krulig New Melan Sunblock SPF 50 30 mg/mL; 50 mg/mL; 100 mg/mLthis 84857-0545-00 KRULIG 100 ml — — FDA listed —
SunPlus SPF 30 Everyday Inspired Broad Spectrum Sunscreen 30 mg/mL; 50 mg/mL; 100 mg/mL 84661-0522-00 SUNPLUS 177 ml — — FDA listed —
PoolBar I Scream For Sunscreen SPF 50 Coconut and Vanilla 30 mg/mL; 50 mg/mL; 100 mg/mL 84953-0874-00 POOLBAR 150 ml — — FDA listed —
Visor Clear Body Mist Hydrating Sunscreen SPF 50 30 mg/mL; 50 mg/mL; 100 mg/mL 85335-0597-00 VISOR 177 ml — — FDA listed —
SPF Ginger Sunscreen SPF 50 30 mg/mL; 50 mg/mL; 100 mg/mL 87341-0928-00 SPF 177 ml — — FDA listed —
Inkeeze Tattoo Products Hi-Definition Tattoo Sunscreen SPF 50 Coconut Scent 30 mg/mL; 50 mg/mL; 100 mg/mL 87440-0901-00 Ink-eeze 177 ml — — FDA listed —
Frase Skin SPF 50 Activated Vitamin D Technology Cool 30 mg/mL; 50 mg/mL; 100 mg/mL 87675-0959-00 Frase 177 ml — — 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
Oct 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.

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 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 QN83US2B0N
    Ascorbyl palmitate is a fat-soluble form of vitamin C used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down and becoming less stable over time.
  • UNII 2EH13UN8D3
    A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
  • UNII FGL3685T2X
    Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
  • UNII YY7C30VXJT
    A natural plant extract from cucumber that adds flavor and freshness to medicines. It may also serve as a moisturizing agent or mild preservative in topical or oral formulations.
  • UNII BKJ0J3D1BP
    A plant-derived ingredient from sunflower flowers, used as a natural colorant and flavoring agent in medicines. It may help provide color or mild taste to the product.

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

The official label also statesAcrylates/Octylacrylamide Copolymer, Aloe Barbadensis Leaf (Aloe Vera) Extract, Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Helianthus Annuus (Sunflower) Oil, Parfum (Fragrance), SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E).

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerKRULIG INTERNATIONAL, INC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84857
First marketedOct 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.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 45 words ▾

Uses Helps prevent sunburn. Higher SPF gives more sunburn protection Retains SPF after 80 minutes of swimming or sweating 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 113 words ▾

Directions Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours do not spray directly on face.

Spray into hands and apply to face. Use in well-ventilated areas Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.

To decrease the risk, regularly use a sunscreen with broad spectrum SPF 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

⚠️ Warnings 83 words ▾

Warnings For external use only Do not use on damaged or broken skin. When using this product keep out of eyes.Rinse with water to remove. Do not puncture or incinerate.

Contents under pressure. Do not store it at temperatures above 120°F. Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use

🧪 Active Ingredient 10 words ▾

Active Ingredient Avobenzone 3.00% Octisalate 5.00% Octocrylene 10.00% Purpose Sunscreen

🧪 Inactive Ingredients 37 words ▾

Inactive Ingredients Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Leaf (Aloe Vera) Extract, Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Helianthus Annuus (Sunflower) Oil, Parfum (Fragrance), SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E).

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin.

📄 When Using This Product 28 words ▾

When using this product keep out of eyes.Rinse with water to remove. Do not puncture or incinerate. Contents under pressure. Do not store it at temperatures above 120°F.

📄 Stop Use and Ask a Doctor If 13 words ▾

Stop use and ask a doctor if rash or irritation develops and lasts.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 14 words ▾

Questions? +34 645 66 06 12 For Europe +1 954 914 5722 For America

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling: Label

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

Reported adverse events (FAERS)

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

Top reported reactions

Rash3
Skin Cancer3
Application Site Burn2
Hypersensitivity2
Product Expiration Date Issue2
Product Lot Number Issue2
Acne1

Age at onset

Adult1
Elderly2

Reporter sex

20 reports
Male · 12%
Female · 88%

Serious outcomes

Hospitalization1
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by KRULIG INTERNATIONAL, INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
KRULIG INTERNATIONAL, 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.
← 84856-0604-00 · ESALON.COM, 84867-0005-01 · Jiashen →
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.