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ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PA TITANIUM DIOXIDE 121.6 mg/g Cream

by LG Household and Healthcare, Inc. · 1 TUBE in 1 PACKAGE (53208-000-00) / 50 g in 1 TUBE
NDC 53208-0000-00
🏷️ FDA NDC (as labeled) 53208-000-00 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) 53208-000-00
Product NDC 53208-000
11-digit billing NDC 53208000000
UNII 15FIX9V2JP
Application # M020
SPL Set ID 65e70306-9e79-494d-9217-a43002f16307
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-03-13
Route TOPICAL
Dosage form CREAM
Substance TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 53208-000-00 — 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 → 53208-0000-00. 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

LabelerLG Household and Healthcare, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code53208
First marketedMar 2013
Product typeHuman Otc Drug
Portfolio2 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 cream sunscreen marketed as an over-the-counter monograph product. It contains titanium dioxide, a mineral UV filter that functions as a broad-spectrum sunscreen agent, reflecting and scattering ultraviolet rays from the sun. The product is formulated to provide SPF 40 sun protection and is typically applied to the skin to help reduce sun exposure. As an OTC monograph drug, it is made according to established FDA standards for nonprescription sunscreen products.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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
ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PA 121.6 mg/gthis 53208-0000-00 LG 1 tube — — FDA listed —
O HUI Sun Science Ideal Cover Sunscreen Broad Spectrum 121.6 mg/g 53208-0001-00 LG 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

🏛️
2013
On the market since
Mar 2013
📍
2026
Currently FDA-listed
13 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 ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PA (this brand).

Top reported reactions

Hypersensitivity17
Abdominal Pain Upper13
Reaction To Excipient13
Madarosis11
Dyspnoea8
Erythema7
Pain In Extremity7

Age at onset

Adolescent1
Adult6
Elderly5

Reporter sex

95 reports
Male · 51%
Female · 49%

Serious outcomes

Hospitalization37
Death23
Life-threatening16
Disabling14
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7 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
53208-0000-00 You're viewing this 1 TUBE in 1 PACKAGE (53208-000-00) / 50 g in 1 TUBE 2017-12-19 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 53208-000-00, 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: 53208-0000-00, written without dashes as 53208000000. 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 53208-0000-00, the first segment (53208) is the labeler code FDA assigned to LG Household and Healthcare, Inc.; the middle segment (0000) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 LG Household and Healthcare, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
LG Household and Healthcare, 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. Higher SPF gives more sunburn protection.

⏱️ Dosage and Administration 26 words ▾

Directions Apply liberally before exposure to the sun. Reapply after excessive perspiration or swimming. Ask a doctor before use on children under 3 years of age.

⚠️ Warnings 66 words ▾

Warnings For External use only. Do not use on irritated or broken skin. Stop use and ask a physician if rash, irritation or sensitivity develops and lasts. When using product do not get into eyes. If eye contact occurs, rinse eyes thoroughly with water. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active ingredients Titanium Dioxide 12.16%

🧪 Inactive Ingredients 153 words ▾

Inactive ingredients Water(Aqua/Eau), Cyclopentasiloxane, Butylene Glycol, Aluminum Starch Octenylsuccinate, Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Ascorbyl Glucoside, Neopentyl Glycol Dicaprate, Glycereth-26, Phenyl Trimethicone, Caprylyl Methicone, Dimethicone, Alumina, Dimethicone Vinyl Dimethicone Crosspolymer, Dipropylene Glycol, Sodium Chloride, Disteardimonium Hectorite, PEG/PPG-20/15 Dimethicone, Malus Domestica Fruit Cell Culture Extract, Butyrospermum Parkii (Shea) Butter, Citrus Aurantium Dulcis (Orange) Oil, Chamomilla Recutita (Matricaria) Flower Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Olea Europaea (Olive) Fruit Oil, Humulus Lupulus (Hops) Extract, Achillea Millefolium Extract, Melissa Officinalis Leaf Extract, Viscum Album (Mistletoe) Leaf Extract, Dipotassium Glycyrrhizate, SH-Polypeptide-7, Oligopeptide-68, Squalane, Hydrogenated Lecithin, Phytosterols, Ceramide 3, Sodium Hyaluronate, Hydrolyzed Wheat Protein/PVP Crosspolymer, Hydrolyzed Pea Protein, Acrylates/C12-22 Alkyl Methacrylate Copolymer, BetaGlucan, Panthenol, Glycerin, Adenosine, Tocopheryl Acetate, PEG/PPG-18/18 Dimethicone, Tocopherol, Sodium PCA, Allantoin, Lecithin, Methicone, Alcohol, Boron Nitride, Hydroxyethylcellulose, Urea, Xanthan Gum, Potassium Hydroxide, Silica, Triethoxycaprylylsilane, Sodium Oleate, Iron Oxides (C.I.

77491), Iron Oxides (C.I. 77492), Iron Oxides (C.I. 77499), Disodium EDTA, EDTA, Caprylyl Glycol, Phenoxyethanol, Fragrance.

🎯 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 ↗
← 53205-0001-01 · D-COL 53208-0001-00 · LG →
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.