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Ultra Sunscreen Octinoxate, Octisalate, Titanium Dioxide .09 g/mL; .035 g/mL; .027 g/mL Emulsion, 473 mL — NDC 85448-0003-01 package photo

Ultra Sunscreen Octinoxate, Octisalate, Titanium Dioxide .09 g/mL; .035 g/mL; .027 g/mL Emulsion, 473 mL

by Jiangsu Senwo Medical Technology Co., Ltd. · 473 mL in 1 BOTTLE (85448-003-01)
NDC 85448-0003-01
🏷️ FDA NDC (as labeled) 85448-003-01 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) 85448-003-01
Product NDC 85448-003
11-digit billing NDC 85448000301
UNII 4Y5P7MUD51, 4X49Y0596W, 15FIX9V2JP
Application # M020
SPL Set ID 4ed974b8-6c11-08e0-e063-6294a90a7713
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-07
Route TOPICAL
Dosage form EMULSION
Substance OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 85448-003-01 — 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 → 85448-0003-01. 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

LabelerJiangsu Senwo Medical Technology Co., Ltd.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code85448
First marketedApr 2026
Product typeHuman Otc Drug
Portfolio3 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?

Ultra Sunscreen is a topical emulsion (lotion-type product) containing three active ingredients that function as ultraviolet light filters. Octinoxate and octisalate are organic UV-absorbing compounds commonly used in sunscreen formulations, while titanium dioxide is an inorganic mineral that reflects and scatters UV rays. This OTC monograph product is typically used to help protect skin from 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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII 5QB0T2IUN0
    Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
  • UNII F01RIY4371
    A synthetic polymer made from acrylic compounds and taurate, this substance acts as a thickener and stabilizer. It helps give liquid medicines a smooth texture and keeps ingredients from separating.
  • UNII FLS0C20S53
    A beneficial bacterium used as a processing aid in some pharmaceutical manufacturing. It may help break down or process certain ingredients during production, then is removed or inactivated before the medicine reaches you.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII LED42LZG6O
    C13-16 isoparaffin is a mixture of refined mineral oils derived from petroleum. It acts as a solvent and emollient in topical formulations, helping dissolve active ingredients and soften the skin.
  • UNII F4K100DXP3
    Dibutyl adipate is a synthetic oily liquid derived from adipic acid. It serves as a plasticizer and solvent in medicines, helping softens coatings and improves flexibility so tablets and capsules don't crack or break.
  • UNII 935E97BOY8
    Folic acid is a synthetic form of a B vitamin. In medicines, it's added as a nutritional supplement or to help prevent vitamin deficiency, especially in prenatal formulas.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII AAZ2QV38TA
    Hydrolyzed sodium hyaluronate is a salt form of hyaluronic acid, a naturally occurring substance found in connective tissue. In medicines, it serves as a humectant and thickener to improve texture, retain moisture, and enhance product stability.
  • UNII G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII N8F53B3R4R
    A synthetic humectant and solvent derived from propane. It draws and holds moisture in the formulation, helping keep the medicine stable and improving texture or flow in liquid and semi-solid products.
  • 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 4KDO9AFM9I
    A plant-derived emulsifier made from olive oil and polyglycerols. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • UNII Y9WL8QN3ZB
    A plant-derived emulsifier made from glycerin and myristic acid. It helps mix oil and water-based ingredients together and keeps them blended throughout the product's shelf life.
  • UNII 9229XJ4V12
    A synthetic emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients in formulations, keeping them mixed and preventing separation.
  • UNII ZI1LK470XV
    A synthetic emulsifier made from glycerin and stearic acid. It helps keep oil and water mixed together in the product and improves texture and stability.
  • UNII G4AYJ54K59
    A plant-derived emulsifier made from glycerin and oleic acid. It helps mix oil and water-based ingredients together and keeps them blended throughout the product's shelf life.
  • UNII NG5NG5733T
    A synthetic polymer derived from acrylic acid and taurine. It functions as a suspending agent and emulsifier, helping keep ingredients evenly distributed and preventing separation in liquid or semi-solid medicines.
  • UNII 0W8RRI5W5A
    A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII G624N6MSBA
    A synthetic surfactant derived from coconut oil. It helps dissolve and distribute other ingredients evenly throughout the medicine, acting as an emulsifier and solubilizer in liquid formulations.
  • 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.

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

The official label also statesWater, Glycerin, Methylpropanediol, Dibutyl Adipate, Alcohol, Ammonium PolyacryloyldimethylTaurate, Octyldodecyl Neopentanoate, 1,2-Hexanediol, Hydroxyacetophenone, Olive OilPolyglyceryl-6 Esters, Sorbitan Sesquioleate, Trideceth-10, Polyglyceryl-2Dipolyhydroxystearate, Polyglyceryl-6 Oleate, Sodium Polyacryloyldimethyl Taurate, C13-16Isoparaffin, Bisabolol, Polyglyceryl-10 Myristate, Fragrance, Allantoin, Polyglyceryl-3 Distearate,Aluminum Hydroxide, Stearic Acid, Hydrolyzed Sodium Hyaluronate, Butylene Glycol, 1.2-Pentanediol, Bacillus/Soybean Ferment Extract, Folic Acid, Sodium Hyaluronate

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 mLPer 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 Sunscreen .09 g/mL; .035 g/mL; .027 g/mLthis 85448-0003-01 Jiangsu 473 ml — — 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

🏛️
2026
On the market since
Apr 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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
85448-0003-01 You're viewing this 473 mL in 1 BOTTLE (85448-003-01) 2026-04-07 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 85448-003-01, 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: 85448-0003-01, written without dashes as 85448000301. 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 85448-0003-01, the first segment (85448) is the labeler code FDA assigned to Jiangsu Senwo Medical Technology Co., Ltd.; the middle segment (0003) 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 Jiangsu Senwo Medical Technology Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Jiangsu Senwo Medical Technology Co., Ltd. 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 3 words ▾

Soothing + Moisturizing

⏱️ Dosage and Administration 91 words ▾

Shake well. 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 asunscreen with a Broad Spectrum SPF value of 15 or higher and other sunprotection 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 4 words ▾

For external use only.

🧪 Active Ingredient 16 words ▾

Methoxy cinnamic acid ethylhexyl ester 7.5% Diethanolamine hydroxybenzyl benzoate 3.5% Octyl methoxycinnamate 1.5% Titanium dioxide 2.7%

🧪 Inactive Ingredients 48 words ▾

Water, Glycerin, Methylpropanediol, Dibutyl Adipate, Alcohol, Ammonium PolyacryloyldimethylTaurate, Octyldodecyl Neopentanoate, 1,2-Hexanediol, Hydroxyacetophenone, Olive OilPolyglyceryl-6 Esters, Sorbitan Sesquioleate, Trideceth-10, Polyglyceryl-2Dipolyhydroxystearate, Polyglyceryl-6 Oleate, Sodium Polyacryloyldimethyl Taurate, C13-16Isoparaffin, Bisabolol, Polyglyceryl-10 Myristate, Fragrance, Allantoin, Polyglyceryl-3 Distearate,Aluminum Hydroxide, Stearic Acid, Hydrolyzed Sodium Hyaluronate, Butylene Glycol, 1.2-Pentanediol, Bacillus/Soybean Ferment Extract, Folic Acid, Sodium Hyaluronate

🎯 Purpose 1 words ▾

Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85448-0002-01 · Jiangsu 85449-0201-85 · MCRAE →
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.