Home › NDC Lookup › Ingredients › Octocrylene, Octisalate, Avobenzone › 52854-0927-01
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Land Shark SPF 30 octocrylene, octisalate, avobenzone 5 g/100g; 3 g/100g; 2.5 g/100g Lipstick, 4.44 g

by Tropical Seas, Inc. · 4.44 g in 1 TUBE (52854-927-01)
NDC 52854-0927-01
🏷️ FDA NDC (as labeled) 52854-927-01 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) 52854-927-01
Product NDC 52854-927
11-digit billing NDC 52854092701
UNII 5A68WGF6WM, 4X49Y0596W, G63QQF2NOX
UPC 0079608937964
Application # M020
SPL Set ID b55a0bd0-2a32-2977-e053-2a95a90aa142
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-08-03
Route TOPICAL
Dosage form LIPSTICK
Substance OCTOCRYLENE; OCTISALATE; AVOBENZONE
Why two NDCs? The FDA registers this code as 52854-927-01 — 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 → 52854-0927-01. 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

LabelerTropical Seas, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code52854
First marketedAug 2020
Product typeHuman Otc Drug
Portfolio29 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?

Land Shark SPF 30 is an over-the-counter sunscreen lipstick containing three ultraviolet (UV) filters: avobenzone, octisalate, and octocrylene. These active ingredients are commonly used together in sunscreen products to help absorb and scatter UVA and UVB rays from the sun. This lipstick is applied topically to the lips as part of sun protection routines. Because this product is marketed under the FDA's over-the-counter monograph rules for sunscreens, it follows established category guidelines for sun-protective ingredients and their concentrations.

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 R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 5L694Y0T22
    A silicone-based lubricant derived from cetyl alcohol and dimethicone. It reduces friction between tablet particles and equipment surfaces, helping pills slide smoothly during manufacturing and making them easier to swallow.
  • UNII 3RT3536DHY
    A natural plant material derived from coconut that serves as a filler and texturizing agent in medicines. It helps give the product structure and consistency.
  • UNII FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • UNII T53SBG6741
    A plant-based oil extracted from sea buckthorn seeds. It's used as an emollient and skin-conditioning agent to soften the medicine's texture and improve how it feels or spreads on skin.
  • UNII ZF94AP8MEY
    Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
  • 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 GPW77G0937
    Lauryl laurate is a synthetic oily compound made from lauric acid and lauryl alcohol. It acts as an emollient and lubricant in medicines, helping to soften formulations and reduce friction during manufacturing and use.
  • UNII X8725R883T
    A synthetic oily liquid derived from branched carboxylic acids, used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product's texture while improving how it spreads on skin.
  • UNII 6UYK2W1W1E
    A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
  • UNII 0C143929GK
    Phenethyl benzoate is a synthetic fragrance and flavoring agent used in medicines to mask unpleasant tastes or add pleasant aroma to improve patient acceptance of the medication.
  • 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 statesricinus communis (castor) seed oil, cetearyl alcohol, lauryl laurate, olea europaea (olive) fruit oil, hydrogenated castor oil, beeswax, copernicia cerifera (carnauba) wax, flavor, hydrogenated soybean oil, euphorbia cerifera (candelilla) wax, flavor, glyceryl stearate, octyl dodecyl citrate crosspolymer, phenethyl benzoate, cocos nucifera (coconut) fruit extract, octyldodecyl neopentanoate, cetyl dimethicone, hippophae rhamnoides (sea buckthorn) oil.

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
Expedition BackCountry SPF 30 5 g/100g; 3 g/100g; 2.5 g/100g 52854-0976-01 Tropical 4.44 g — — FDA listed —
Land Shark SPF 30 5 g/100g; 3 g/100g; 2.5 g/100g 52854-0981-01 Tropical 4.44 g — — FDA listed —
Land Shark SPF 30 5 g/100g; 3 g/100g; 2.5 g/100gthis 52854-0927-01 Tropical 4.44 g — — FDA listed —
Land Shark SPF 30 5 g/100g; 3 g/100g; 2.5 g/100g 52854-0983-01 Tropical 4.44 g — — FDA listed —
Land Shark SPF 30 5 g/100g; 3 g/100g; 2.5 g/100g 52854-0982-01 Tropical 4.44 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

🏛️
2020
On the market since
Aug 2020
📍
2026
Currently FDA-listed
6 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
52854-0927-01 You're viewing this 4.44 g in 1 TUBE (52854-927-01) 2020-08-03 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 52854-927-01, 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: 52854-0927-01, written without dashes as 52854092701. 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 52854-0927-01, the first segment (52854) is the labeler code FDA assigned to Tropical Seas, Inc.; the middle segment (0927) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Tropical Seas, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Tropical Seas, 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.

📄 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 10 words ▾

Uses helps prevent sunburn helps prevent chapped or cracked skin

⏱️ Dosage and Administration 92 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 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 24 words ▾

Warnings For external use only *Keep out of eyes Stop use and ask a doctor if rash occurs Keep out of reach of children.

🧪 Active Ingredient 8 words ▾

Active Ingredients Octocrylene 5.0% Octisalate 3.0% Avobenzone 2.5%

🧪 Inactive Ingredients 55 words ▾

Inactive Ingredients ricinus communis (castor) seed oil, cetearyl alcohol, lauryl laurate, olea europaea (olive) fruit oil, hydrogenated castor oil, beeswax, copernicia cerifera (carnauba) wax, flavor, hydrogenated soybean oil, euphorbia cerifera (candelilla) wax, flavor, glyceryl stearate, octyl dodecyl citrate crosspolymer, phenethyl benzoate, cocos nucifera (coconut) fruit extract, octyldodecyl neopentanoate, cetyl dimethicone, hippophae rhamnoides (sea buckthorn) oil.

🎯 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 ↗
← 52854-0920-01 · Tropical 52854-0928-01 · Tropical →
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.