Home › NDC Lookup › Ingredients › Homosalate 8%, Octisalate 5.0%, Avobenzo... › 84190-0001-02
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(from DailyMed)

Ultra Light Invisible SPF 40 sunscreen Homosalate 8%, Octisalate 5.0%, Avobenzone 3.0%, Octocrylene 4.0% 3 g/100mL; 8 g/100mL; 5 g/100mL; 4 g/100mL Gel

by RK Shea LLC · 1 TUBE in 1 CARTON (84190-001-02) / 50 mL in 1 TUBE
NDC 84190-0001-02
🏷️ FDA NDC (as labeled) 84190-001-02 billing pads the product segment with a zero
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 →

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) 84190-001-02
Product NDC 84190-001
11-digit billing NDC 84190000102
UNII G63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM
UPC 0860011819608
Application # M020
SPL Set ID 02d59d96-0edb-472c-b730-148a2eb4fa4a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-01
Route TOPICAL
Dosage form GEL
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 84190-001-02 — 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 → 84190-0001-02. 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

LabelerRK Shea LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84190
First marketedDec 2025
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?

This is an over-the-counter sunscreen gel applied to the skin that contains four UV-filtering agents: homosalate, octisalate, avobenzone, and octocrylene. These ingredients are typically used together in sunscreen formulations to absorb and scatter ultraviolet light and help protect skin from sun exposure. The product is marketed as an SPF 40 sunscreen under the FDA's OTC monograph rules for sunscreen drugs.

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 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 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 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 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 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 CZ227117JE
    A silicone-based compound made of linked silicon and oxygen atoms arranged in a ring structure. It acts as a solvent, carrier, or conditioning agent to help distribute active ingredients evenly and improve product texture and spreadability.
  • UNII 2RF6EJ0M85
    Diatomaceous earth is a fine powder made from fossilized remains of diatoms, tiny aquatic organisms. It acts as a glidant and anti-caking agent, helping medicine flow smoothly during manufacturing and preventing clumping in the final product.
  • UNII 609A3V1SUA
    A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
  • 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 UF7620L1W6
    A synthetic silicone polymer that acts as a thickener and absorbent in medicines. It helps create the right texture, improves how the product feels on skin or in the mouth, and can absorb excess moisture or oil in formulations.
  • UNII O4I3UFO6ZF
    A silicone-based polymer blend that acts as an emulsifier and texture modifier. It helps keep oil and water mixed together in the formulation and gives the product a smooth, spreadable consistency.
  • UNII S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • UNII 4PW41QCO2M
    Indian frankincense is a natural resin extracted from trees native to India. It is used in medicines as a binder and thickening agent to help hold ingredients together and improve texture.
  • 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 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 3HH93SL2H9
    A plant-derived oil made from meadowfoam seeds. It acts as an emollient and lubricant in medicines, helping soften formulations and improve how ingredients mix together.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 5LKW3C543X
    A synthetic oily liquid derived from neopentyl glycol and heptanoic acid. It serves as an emollient and solvent in formulations, helping to dissolve or suspend active ingredients and improve the texture and spreadability of topical products.
  • UNII 6J1M3WA0ZK
    A red algae-derived mineral rich in calcium carbonate. Used as a filler and buffer to add bulk to the tablet or capsule and help maintain stable pH levels in the formulation.
  • UNII 0841698D2F
    A synthetic polymer used as a film-coating agent to protect tablets and capsules. It helps control how quickly the medicine dissolves and improves the appearance of the finished product.
  • UNII 59Z907ZB69
    A synthetic silicone polymer used as a glidant and anti-caking agent. It reduces friction between particles, helping powders and tablets flow smoothly during manufacturing and use.
  • UNII 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 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 9LBV3F07AZ
    A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during storage.
  • UNII 89DS0H96TB
    Zinc sulfate is a mineral salt used in medications as a source of zinc. It functions as an active nutritional ingredient in some formulations and may also serve as a buffer or pH stabilizer in tablets and liquids.

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

The official label also statesBoswellia Serrata Resin Extract Butyrospermum Parkii (Shea) Butter Caprylic/Capric Triglyceride Caprylyl Glycol Cyclopentasiloxane Cyclotetrasiloxane Cyclohexasiloxane Diatomaceous Earth Dicaprylyl Carbonate Dimethicone Dimethicone Crosspolymer Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer Hyaluronic acid, sodium salt Isododecane Lecithin Lithothamnion Calcareum Extract Mannitol Meadowfoam Estolide Microcrystaline Cellulose Neopentyl Glycol Diheptanoate Polyester-7 Polymethylsilsesquioxane Silica Simmondsia Chinensis (Jojoba) Seed Oil Tetrahexyldecyl Ascorbate Tocopheryl Acetate Zinc Sulfate

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
Ultra Light Invisible SPF 40 sunscreen 3 g/100mL; 8 g/100mL; 5 g/100mL; 4 g/100mLthis 84190-0001-02 RK 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

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year 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
84190-0001-02 You're viewing this 1 TUBE in 1 CARTON (84190-001-02) / 50 mL in 1 TUBE 2025-12-01 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 — 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 FDA registers it as 84190-001-02, 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: 84190-0001-02, written without dashes as 84190000102. 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 84190-0001-02, the first segment (84190) is the labeler code FDA assigned to RK Shea LLC; the middle segment (0001) 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 RK Shea LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
RK Shea LLC 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
🎯 Indications and Usage 5 words ▾

Uses · helps prevent sunburn

⏱️ Dosage and Administration 104 words ▾

Directions Apply evenly by hand 15 minutes before sun exposure · reapply: · after 40 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 of 15 or higher and other sun protection measures including · limit time in the sun, especially from 10 a.m. - 2 p.m. · wear a long-sleeved shirts, pants, hats, and sunglasses. · children under 6 months: Ask a doctor.

⚠️ Warnings 36 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 doctor if rash occurs.

🧪 Active Ingredient 15 words ▾

Active Ingredients Purpose Avobenzone 3% Sunscreen Homosalate 8% Sunscreen Octisalate 5% Sunscreen Octocrylene 4.0% Sunscreen

🧪 Inactive Ingredients 58 words ▾

Inactive ingredients Boswellia Serrata Resin Extract Butyrospermum Parkii (Shea) Butter Caprylic/Capric Triglyceride Caprylyl Glycol Cyclopentasiloxane Cyclotetrasiloxane Cyclohexasiloxane Diatomaceous Earth Dicaprylyl Carbonate Dimethicone Dimethicone Crosspolymer Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer Hyaluronic acid, sodium salt Isododecane Lecithin Lithothamnion Calcareum Extract Mannitol Meadowfoam Estolide Microcrystaline Cellulose Neopentyl Glycol Diheptanoate Polyester-7 Polymethylsilsesquioxane Silica Simmondsia Chinensis (Jojoba) Seed Oil Tetrahexyldecyl Ascorbate Tocopheryl Acetate Zinc Sulfate

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84185-0302-08 · Willo 84192-0123-02 · HEY →
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.