Home › NDC Lookup › Ingredients › Whitening Sunscreenanti Wrinkle › 85819-0441-02
WHITENING SUNSCREENANTI WRINKLE 52.49 g; 8 g Cream, 5 applicators — NDC 85819-0441-02 package photo

WHITENING SUNSCREENANTI WRINKLE 52.49 g; 8 g Cream, 5 applicators

by Shantou Oushiya Biotechnology Co.,Ltd · 5 APPLICATOR in 1 BOX (85819-441-02) / 1 CREAM in 1 APPLICATOR
NDC 85819-0441-02
🏷️ FDA NDC (as labeled) 85819-441-02 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) 85819-441-02
Product NDC 85819-441
11-digit billing NDC 85819044102
UNII 059QF0KO0R, 15FIX9V2JP
SPL Set ID 524384e9-b3f8-4c13-e063-6394a90a8973
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-21
Route TOPICAL
Dosage form CREAM
Substance WATER; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 85819-441-02 — 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 → 85819-0441-02. 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

LabelerShantou Oushiya Biotechnology Co.,Ltd
Labeler code85819
First marketedMay 2026
Product typeHuman Otc Drug
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 homeopathic cream applied to the skin that lists titanium dioxide and water as active ingredients. Titanium dioxide is commonly used in conventional sunscreens as a physical UV filter, and water serves as a base ingredient in topical products. Homeopathic products are marketed based on homeopathic tradition rather than conventional clinical evidence, and the FDA does not evaluate them for safety or effectiveness. This product is categorized as an unapproved homeopathic drug.

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 OL56191M6N
    A synthetic polymer made from two methacrylate compounds. It functions as a film-former and binder in medicines, helping create a protective coating or holding tablet ingredients together.
  • UNII Z5Y843J6KQ
    A chemical compound used as a preservative and antimicrobial agent in topical medications and personal care products. It helps prevent bacterial and fungal growth to maintain product stability and safety during storage.
  • UNII 064BZT8FUU
    A aluminum-based compound mixed with propylene glycol. It acts as an astringent and antiperspirant agent in topical formulations, helping to reduce moisture and tighten skin temporarily.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 8FA93U5T67
    A waxy substance made from plant oils that acts as an emulsifier and thickener. It helps mix oil and water components in the medicine and gives the product a smooth texture.
  • UNII 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 4Y5P7MUD51
    A chemical compound that absorbs ultraviolet light. It is used in topical medicines and sunscreen products as a UV filter to help protect formulations from light degradation and to provide sun protection in the final product.
  • UNII 4X49Y0596W
    Ethylhexyl salicylate is a synthetic organic compound used as a UV filter and penetration enhancer in topical formulations. It helps protect the product and skin from ultraviolet light damage.
  • UNII XQN8R9SAK4
    A synthetic ultraviolet filter compound used in topical formulations to absorb and protect against harmful UV rays. It functions as an active sunscreen agent rather than a traditional inactive filler or binder.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • UNII 918X1OUF1E
    Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
  • UNII 8NT850T0YS
    A synthetic chemical compound used as an ultraviolet light absorber and antioxidant. It protects the medicine from degradation caused by light and oxygen exposure during storage.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII A2Q2LHC6MA
    A synthetic fragrance compound used to add pleasant scent to medications. It serves as a flavoring and masking agent to make the medicine more palatable and appealing to patients.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII G37UFG162O
    A synthetic compound that acts as a preservative and antioxidant in medications. It helps prevent bacterial and fungal growth while protecting the medicine from degradation caused by oxygen exposure.
  • UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 03KCY6P7UT
    A waxy compound derived from cetyl alcohol and phosphoric acid. It acts as an emulsifier to help blend oil and water ingredients, and as a thickener to give the medicine its proper texture and consistency.
  • UNII 1DXE3F3OZX
    A synthetic polymer that forms a gel-like network. It absorbs and holds water, thickens the medicine, and helps keep ingredients evenly mixed throughout the formulation.
  • UNII 06XEA2VD56
    Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
  • UNII M4J84T83QF
    Stannic hydrogen phosphate is an inorganic salt compound containing tin and phosphate. It functions as a buffer and pH stabilizer in medications, helping maintain a stable acidity level so the drug remains effective and safe throughout its shelf life.
  • UNII J4XOG773BG
    A synthetic surfactant and conditioning agent derived from plant-based materials. It works as an emulsifier to help mix oil and water components, and as an antimicrobial preservative to maintain product stability.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • UNII TSZ9EY203A
    Zinc silicate is a white powder made from zinc and silicon compounds. It works as a colorant and anti-caking agent in medicines, helping keep powders dry and free-flowing.

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

The official label also statesSILICA,BUTYLENE GLYCOL,HEXYLENE GLYCOL,GHT AND SO ON

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
Whitening Sunscreenanti Wrinkle 52.49 g/1; 8 gthis 85819-0441-02 Shantou 5 applicators — — 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
May 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
85819-0441-02 You're viewing this 5 APPLICATOR in 1 BOX (85819-441-02) / 1 CREAM in 1 APPLICATOR 2026-05-21 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

WHITENING SUNSCREENANTI WRINKLE 52.49 g/1; 8 g/1 CREAM is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

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 "Unapproved Homeopathic". 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 85819-441-02, 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: 85819-0441-02, written without dashes as 85819044102. 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 85819-0441-02, the first segment (85819) is the labeler code FDA assigned to Shantou Oushiya Biotechnology Co.,Ltd; the middle segment (0441) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Shantou Oushiya Biotechnology Co.,Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Shantou Oushiya Biotechnology 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 29 words ▾

Before going out on a daily basis,take an appropriate amount of this product and apply it evenly to the face(avoiding sensitive areas around the eyes),neck,arms,and leg skin.Gently apply evenly.

⏱️ Dosage and Administration 29 words ▾

Before going out on a daily basis,take an appropriate amount of this product and apply it evenly to the face(avoiding sensitive areas around the eyes),neck,arms,and leg skin.Gently apply evenly.

⚠️ Warnings 6 words ▾

keep out of reach of children

🧪 Active Ingredient 2 words ▾

WATER,TITANIUM DIOXIDE

🧪 Inactive Ingredients 6 words ▾

SILICA,BUTYLENE GLYCOL,HEXYLENE GLYCOL,GHT AND SO ON

🎯 Purpose 14 words ▾

Protects the skin from sun damage and can also delay the formation of wrinkles

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85818-0008-01 · Dr.Johnes 85819-0771-43 · Shantou →
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.