Home › NDC Lookup › 63354-0701-21
🧴image loading
(from DailyMed)

HAWAIIAN TROPIC AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE 9 g/100g; 2.7 g/100g; 5 g/100g; 4.5 g/100g Gel, 9.9 g

by Edgewell Personal Care Brands LLC · 9.9 g in 1 TUBE (63354-701-21)
NDC 63354-0701-21
🏷️ FDA NDC (as labeled) 63354-701-21 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) 63354-701-21
Product NDC 63354-701
11-digit billing NDC 63354070121
UNII 5A68WGF6WM, G63QQF2NOX, V06SV4M95S, 4X49Y0596W
Application # M020
SPL Set ID 228055ec-ff59-4412-e063-6394a90abe14
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-10-01
Route TOPICAL
Dosage form GEL
Substance OCTOCRYLENE; AVOBENZONE; HOMOSALATE; OCTISALATE
Why two NDCs? The FDA registers this code as 63354-701-21 — 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 → 63354-0701-21. 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

LabelerEdgewell Personal Care Brands LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code63354
First marketedOct 2024
Product typeHuman Otc Drug
Portfolio111 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is a topical gel sunscreen marketed as an over-the-counter monograph product. It contains four ultraviolet light filters: avobenzone, homosalate, octisalate, and octocrylene. These ingredients are typically used together in sunscreen formulations to absorb and scatter both UVA and UVB radiation from the sun. The product is applied to the skin as a protective barrier against sun exposure.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII WL0328HX19
    A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
  • UNII Q1LS2UJO3A
    Ceresin is a purified mineral wax derived from ozocerite. It functions as a binding agent, thickener, and coating material in medicines to help hold ingredients together and provide texture or protective coating.
  • 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 512OYT1CRR
    Cocoa butter is a natural fat extracted from cocoa beans. It's used in medicines as a base for suppositories and as a lubricant to help pills dissolve smoothly.
  • UNII JY81OXM1OM
    A plant-based oil from coconut that has been chemically treated to solidify it. It acts as a binder and filler to help hold tablet ingredients together and give the pill its shape and firmness.
  • UNII A2M91M918C
    A plant-based oil derived from soybeans that has been chemically hardened to make it solid or semi-solid at room temperature. It acts as a binder, filler, and lubricant to help hold the tablet together and allow it to move smoothly during manufacturing and packaging.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII Z98M8HW9A6
    A waxy substance made from beeswax combined with polyglycerin. It acts as an emulsifier and thickener in topical formulations, helping blend oil and water-based ingredients together and giving the product a smooth, creamy texture.
  • 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 0YON5MXJ9P
    A natural sweetener extracted from stevia plant leaves. It's used in medicines to improve taste without adding calories, making bitter drugs easier to take.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII 08MNR5YE2R
    A wax made in a laboratory to mimic natural beeswax. It's used as a coating, binder, and thickener to give medicines a smooth texture and protect them from moisture.
  • UNII 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 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 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

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

The official label also statesPetrolatum, Theobroma Cacao (Cocoa) Seed Butter, Beeswax, Ozokerite, Polyglyceryl-3 Beeswax, Polydipentene, Butyrospermum Parkii (Shea) Butter, Hydrogenated Coconut Oil, Hydrogenated Soybean Oil, Flavor, Synthetic Beeswax, Euphorbia Cerifera (Candelilla) Wax, Cetyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Lecithin, Stevioside, Tocopherol, Water.

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
Hawaiian Tropic 9 g/100g; 2.7 g/100g; 5 g/100g; 4.5 g/100gthis 63354-0701-21 Edgewell 9.9 g — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2024
On the market since
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.

🔬 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 Hawaiian Tropic (this brand).

Top reported reactions

Exposure To Toxic Agent7
Acute Myeloid Leukaemia5
Product Contamination Chemical5
Application Site Swelling4
Rash4
Skin Cancer4
Application Site Erythema3

Age at onset

Child2
Adolescent3
Adult4
Elderly1

Reporter sex

31 reports
Male · 32%
Female · 68%

Serious outcomes

Hospitalization5
Life-threatening1
Disabling1
Death1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63354-0701-21 You're viewing this 9.9 g in 1 TUBE (63354-701-21) 2024-10-01 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 63354-701-21, 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: 63354-0701-21, written without dashes as 63354070121. 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 63354-0701-21, the first segment (63354) is the labeler code FDA assigned to Edgewell Personal Care Brands LLC; the middle segment (0701) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (21) 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 Edgewell Personal Care Brands LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Edgewell Personal Care Brands 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 🎯 Purpose
🎯 Indications and Usage 31 words ▾

Uses • helps prevent sunburn • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early aging caused by the sun.

⏱️ Dosage and Administration 101 words ▾

Directions • apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • 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: Ask a doctor

⚠️ Warnings 61 words ▾

Warnings For external use only. May stain some fabrics. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with warm water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active Ingredients: Avobenzone 2.7%, Homosalate 5.0%, Octisalate 4.5%, Octocrylene 9.0%

🧪 Inactive Ingredients 41 words ▾

Inactive Ingredients: Petrolatum, Theobroma Cacao (Cocoa) Seed Butter, Beeswax, Ozokerite, Polyglyceryl-3 Beeswax, Polydipentene, Butyrospermum Parkii (Shea) Butter, Hydrogenated Coconut Oil, Hydrogenated Soybean Oil, Flavor, Synthetic Beeswax, Euphorbia Cerifera (Candelilla) Wax, Cetyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Lecithin, Stevioside, Tocopherol, Water.

🎯 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 ↗
← 63354-0689-10 · Edgewell 63354-0703-12 · Edgewell →
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.