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CENTELLA RELIEF SOOTHING SUNSCREEN Avobenzone, Homosalate, Octisalate, Octocrylene 9 g/100mL; 2.85 g/100mL; 7 g/100mL; 4.5 g/100mL Lotion — NDC 83403-0100-02 package photo

CENTELLA RELIEF SOOTHING SUNSCREEN Avobenzone, Homosalate, Octisalate, Octocrylene 9 g/100mL; 2.85 g/100mL; 7 g/100mL; 4.5 g/100mL Lotion

by IUNIK Co., Ltd. · 1 TUBE in 1 BOX (83403-100-02) / 60 mL in 1 TUBE (83403-100-01)
NDC 83403-0100-02
🏷️ FDA NDC (as labeled) 83403-100-02 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 →

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) 83403-100-02
Product NDC 83403-100
11-digit billing NDC 83403010002
UNII 5A68WGF6WM, G63QQF2NOX, V06SV4M95S, 4X49Y0596W
Application # M020
SPL Set ID 47d170e3-dd76-d413-e063-6294a90ae8e4
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-07
Route TOPICAL
Dosage form LOTION
Substance OCTOCRYLENE; AVOBENZONE; HOMOSALATE; OCTISALATE
Why two NDCs? The FDA registers this code as 83403-100-02 — 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 → 83403-0100-02. 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

LabelerIUNIK Co., Ltd.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83403
First marketedJan 2026
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?

Centella Relief Soothing Sunscreen is a topical lotion sunscreen marketed as an over-the-counter monograph product. It contains four active ingredients (avobenzone, homosalate, octisalate, and octocrylene) that function as ultraviolet light absorbers, commonly used together in sunscreen formulations to help protect skin from UV exposure. The product is applied directly to the skin as part of sun protection routines.

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 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 01J18G9G97
    Acetyl glutamine is an amino acid derivative made by attaching an acetyl group to the amino acid glutamine. It may be used as a buffering agent, pH regulator, or stability enhancer in pharmaceutical formulations.
  • UNII H70115MP4A
    A natural plant extract from Annickia chlorantha bark used as a flavoring agent and preservative in medicines. It may help mask bitter tastes and extend shelf life.
  • 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 D64PM5UT4U
    A synthetic plastic-like material made from behenyl acrylate monomers. It's used as a film-former and binder to help hold tablet ingredients together and create protective coatings on medications.
  • 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 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 7M867G6T1U
    Centella asiatica is a plant extract used in medicines as a skin-conditioning or soothing ingredient. It helps maintain product stability and may support skin comfort in topical formulations.
  • UNII 8MXU1P42J0
    Centella asiatica root is a plant extract used as a skin-conditioning and antioxidant ingredient in topical formulations. It helps maintain product stability and supports the texture or feel of creams and lotions.
  • 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 58B69Q84JO
    A plant-derived emulsifier made from olive oil and fatty alcohols. It helps blend oil and water ingredients together and stabilizes the product's texture in creams, lotions, and similar formulations.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII CI71S98N1Z
    A mineral salt containing potassium and phosphate, used as a buffer to help maintain the medicine's pH level and stability during storage.
  • UNII I0DQJ7YGXM
    A synthetic chemical compound used as a plasticizer in pharmaceutical coatings. It makes film coatings more flexible and durable so they don't crack or peel during manufacturing and storage.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII S3KFG6Q5X8
    An organic chemical compound used as a UV filter in topical formulations. It helps protect the medicine or product from degradation caused by sunlight exposure during storage and use.
  • 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 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 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 S73ZQI0GXM
    Methyl trimethicone is a silicone-based lubricant and glidant used in tablets and capsules. It reduces friction between particles and equipment during manufacturing, helping the medicine flow smoothly and compress evenly.
  • UNII 6SMK8R7TGJ
    Oleanolic acid is a natural plant compound used in medicines as a binder and thickening agent. It helps hold tablet ingredients together and can improve how the body absorbs the active drug.
  • 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.
  • UNII 73861X4K5F
    A synthetic polymer used as a binder and thickening agent in tablets and capsules. It helps hold ingredients together and can modify how quickly the medicine dissolves and is absorbed in your body.
  • 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 978D8U419H
    A yeast strain commonly used in food and pharmaceutical manufacturing. In medicines, it may serve as a filler, culture medium carrier, or source of beneficial compounds in probiotic formulations.
  • 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 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • UNII MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • 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 3C8845E7C1
    Tripropylene glycol is a clear liquid made from propylene oxide. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and maintain moisture in the formulation.
  • 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 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesWater, Tripropylene Glycol, Propanediol, Silica, Ethylhexyl Methoxycrylene, Diethylhexy 2,6-Naphthalate, 1,2-Hexanediol, Enantia Chlorantha Bark Extract, Centella Asiatica Extract, Centella Asiatica Leaf Extract, Centella Asiatica Root Extract, Saccharomyces Ferment, Dimethicone, Methyl Trimethicone, Pentylene Glycol, Hydroxyethyl Urea, Poly C10-30 Alky Acrylate, Cetearyl Olivate, Polyacrylic Acid, Tromethamine, Sorbitan Olivate, Dipotassium Phosphate, Acetyl Glutamine, Sodium Stearoyl Glutamate, Butylene Glycol, Ethylhexylglycerin, Cellulose Gum, Tocopherol, Oleanolic Acid, Asiatic Acid, Asiaticoside, Madecassic Acid, Madecassoside, Cetyl Alcohol, Carborer, Xanthan Gum

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.
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
Centella Relief Soothing Sunscreen 9 g/100mL; 2.85 g/100mL; 7 g/100mL; 4.5 g/100mLthis 83403-0100-02 IUNIK 1 tube — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

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

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

🔬 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 CENTELLA RELIEF SOOTHING SUNSCREEN (this brand).

Top reported reactions

Acute Myeloid Leukaemia2
Exposure To Toxic Agent2
Product Contamination Chemical2
Rash2
Anaphylactic Reaction1
Application Site Erythema1
Application Site Exfoliation1

Age at onset

Adolescent2
Adult1

Reporter sex

6 reports
Male · 20%
Female · 80%

Serious outcomes

Hospitalization2
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 2 1
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
83403-0100-02 You're viewing this 1 TUBE in 1 BOX (83403-100-02) / 60 mL in 1 TUBE (83403-100-01) 2026-01-07 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 83403-100-02, 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: 83403-0100-02, written without dashes as 83403010002. 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 83403-0100-02, the first segment (83403) is the labeler code FDA assigned to IUNIK Co., Ltd.; the middle segment (0100) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 IUNIK Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
IUNIK Co., Ltd. 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 31 words ▾

USES - Helps prevent sunburn. - If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.

⏱️ Dosage and Administration 92 words ▾

DIRECTIONS Apply liberally 15 minutes before sun exposure. 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. Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

⚠️ Warnings 54 words ▾

WARNINGS For external use only. Do not use on damaged or broken skin. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask 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 11 words ▾

ACTIVE INGREDIENTS Avobenzone 2.84% Homosalate 7.0 % Octisalate 4.5% Octocrylene 9.0%

🧪 Inactive Ingredients 73 words ▾

INACTIVE INGREDIENTS Water, Tripropylene Glycol, Propanediol, Silica, Ethylhexyl Methoxycrylene, Diethylhexy 2,6-Naphthalate, 1,2-Hexanediol, Enantia Chlorantha Bark Extract, Centella Asiatica Extract, Centella Asiatica Leaf Extract, Centella Asiatica Root Extract, Saccharomyces Ferment, Dimethicone, Methyl Trimethicone, Pentylene Glycol, Hydroxyethyl Urea, Poly C10-30 Alky Acrylate, Cetearyl Olivate, Polyacrylic Acid, Tromethamine, Sorbitan Olivate, Dipotassium Phosphate, Acetyl Glutamine, Sodium Stearoyl Glutamate, Butylene Glycol, Ethylhexylglycerin, Cellulose Gum, Tocopherol, Oleanolic Acid, Asiatic Acid, Asiaticoside, Madecassic Acid, Madecassoside, Cetyl Alcohol, Carborer, Xanthan Gum

🎯 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 ↗
← 83402-0003-30 · Pharmheal 83403-0101-02 · IUNIK →
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.