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HAWAIIAN TROPIC AVOBENZONE OCTISALATE OCTOCRYLENE 2.5 g/100g; 2 g/100g; 3 g/100g Oil, 236 g — NDC 63354-0317-16 package photo

HAWAIIAN TROPIC AVOBENZONE OCTISALATE OCTOCRYLENE 2.5 g/100g; 2 g/100g; 3 g/100g Oil, 236 g

by Edgewell Personal Care Brands LLC · 236 g in 1 BOTTLE, PUMP (63354-317-16)
NDC 63354-0317-16
🏷️ FDA NDC (as labeled) 63354-317-16 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) 63354-317-16
Product NDC 63354-317
11-digit billing NDC 63354031716
UNII 4X49Y0596W, G63QQF2NOX, 5A68WGF6WM
Application # M020
SPL Set ID 419b8043-7921-ca77-e063-6394a90a99ba
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-09-11
Route TOPICAL
Dosage form OIL
Substance OCTISALATE; AVOBENZONE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 63354-317-16 — 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 → 63354-0317-16. 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

LabelerEdgewell Personal Care Brands LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code63354
First marketedSep 2023
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?

Hawaiian Tropic Avobenzone Octisalate Octocrylene is a topical sunscreen oil that contains three UV-filtering agents. Avobenzone, octisalate, and octocrylene are commonly used together in sunscreen products to absorb and scatter ultraviolet radiation from the sun. This is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for sunscreen ingredients rather than as an individually approved application.

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 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 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid 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 01YAE03M7J
    Beta carotene is a naturally occurring orange pigment found in plants. In medicines, it serves as a colorant to make tablets or capsules appear orange or yellow.
  • UNII L56Z1JK48B
    A vegetable-derived ingredient used primarily as a natural colorant and flavoring agent in medicines. It provides orange-yellow color and mild taste to tablets, capsules, or liquids.
  • 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 Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII 8470G57WFM
    Corn oil is a vegetable oil extracted from corn kernels. It's used in medicines as a solvent to dissolve active ingredients and help the body absorb them, and sometimes as a lubricant in capsules.
  • UNII ND733RX3JN
    A synthetic red colorant used to give medicines their color. It helps identify the medication and makes it visually distinguishable from other drugs.
  • UNII 44F3HYL954
    A synthetic yellow dye used to color medicines and supplements. It helps make tablets and capsules visually distinctive for identification and product branding purposes.
  • UNII P7E6YFV72X
    Diisopropyl adipate is a clear, oily liquid derived from adipic acid. It acts as a plasticizer and solvent in medicines, helping soften coatings and improve how the drug dissolves or spreads in the body.
  • UNII 4PC054V79P
    A fatty acid derived from glycerin and oleic acid (a natural oil component). It acts as an emulsifier to help mix oil and water-based ingredients, and serves as a lubricant and surfactant in the formulation.
  • UNII 74O70D6VG0
    Guava is a tropical fruit used as a flavoring agent and natural coloring source in medications. It adds fruity taste and may provide a mild sweetening effect to make medicines more palatable.
  • UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII I629I3NR86
    A natural flavoring derived from mango fruit, used to add taste and aroma to medicines. It helps mask bitter or unpleasant flavors, making the medication more pleasant to take.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII KU94FIY6JB
    A natural enzyme extract from papaya fruit that helps break down proteins. It's used in some medicines as a digestive aid ingredient and may help tablets dissolve or break apart in the stomach.
  • UNII SF206I8G4P
    A plant extract from passion fruit used in medicines as a natural flavoring agent and to add mild taste appeal to oral formulations.
  • UNII DR0K5NOJ4R
    Phenyl trimethicone is a silicone-based lubricant and glidant. It helps powder particles flow smoothly and reduces friction during tablet or capsule manufacturing and filling.
  • UNII 8P7XXY759H
    A natural extract from plumeria rubra flowers used in cosmetic and topical formulations. It typically functions as a fragrance, skin-conditioning agent, or botanical extract to add sensory appeal and traditional plant-based properties to the product.
  • UNII 1NA5AO9GH7
    A synthetic polymer derived from petroleum, polybutene is used as a binder and lubricant in solid medications to help hold ingredients together and improve the tablet or capsule's flow during manufacturing.
  • 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 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
  • UNII W4888I119H
    Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.

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

The official label also statesMineral Oil, Diisopropyl Adipate, Isopropyl Myristate, Silica, Fragrance, Cocos Nucifera (Coconut) Oil, Polybutene, Theobroma Cacao (Cocoa) Seed Butter, Glycine Soja (Soybean) Oil, Tocopheryl Acetate, Zea Mays (Corn) Oil, Arginine, Histidine, Phenyl Trimethicone, Tartaric Acid, Daucus Carota Sativa (Carrot) Root Extract, Ascorbyl Palmitate, Glyceryl Oleate, Aloe Barbadensis Leaf Extract, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Beta-Carotene, Red 17, Yellow 11.

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 eachPer 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 2.5 g/100g; 2 g/100g; 3 g/100g 63354-0319-16 Edgewell 236 g — — FDA listed —
Hawaiian Tropic 2.5 g/100g; 2 g/100g; 3 g/100gthis 63354-0317-16 Edgewell 236 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

🏛️
2023
On the market since
Sep 2023
📍
2026
Currently FDA-listed
3 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
63354-0317-16 You're viewing this 236 g in 1 BOTTLE, PUMP (63354-317-16) 2023-09-11 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 63354-317-16, 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: 63354-0317-16, written without dashes as 63354031716. 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 63354-0317-16, the first segment (63354) is the labeler code FDA assigned to Edgewell Personal Care Brands LLC; the middle segment (0317) 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 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 32 words ▾

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 83 words ▾

Directions • apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every two hours • Sun Protection Measures. Spending time in the sun 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 long-sleeve shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor

⚠️ Warnings 61 words ▾

Warnings For external use only May stain some fabrics and surfaces. Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop 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 8 words ▾

Active Ingredients Avobenzone 2.0%, Octisalate 2.5%, Octocrylene 3.0%

🧪 Inactive Ingredients 77 words ▾

Inactive Ingredients Mineral Oil, Diisopropyl Adipate, Isopropyl Myristate, Silica, Fragrance, Cocos Nucifera (Coconut) Oil, Polybutene, Theobroma Cacao (Cocoa) Seed Butter, Glycine Soja (Soybean) Oil, Tocopheryl Acetate, Zea Mays (Corn) Oil, Arginine, Histidine, Phenyl Trimethicone, Tartaric Acid, Daucus Carota Sativa (Carrot) Root Extract, Ascorbyl Palmitate, Glyceryl Oleate, Aloe Barbadensis Leaf Extract, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Beta-Carotene, Red 17, Yellow 11.

🎯 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 ↗
← 63354-0312-01 · Edgewell 63354-0319-16 · 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.