HomeNDC LookupIngredientsZinc Oxide, Octinoxate › 85161-0135-01
Poolside Soft Serve Mineral Milk SPF 30 face sunscreen drops Zinc Oxide, Octinoxate .21 g/g; .07 g/g Lotion, 50 g — NDC 85161-0135-01 package photo

Poolside Soft Serve Mineral Milk SPF 30 face sunscreen drops Zinc Oxide, Octinoxate .21 g/g; .07 g/g Lotion, 50 g

by Longway Technology(Guangzhou)Co.,Ltd. · 50 g in 1 BOTTLE, PLASTIC (85161-135-01)
NDC 85161-0135-01
🏷️ FDA NDC (as labeled) 85161-135-01 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 →

🆔 Identity & classification

FDA NDC (as labeled) 85161-135-01
Product NDC 85161-135
11-digit billing NDC 85161013501
UNII SOI2LOH54Z, 4Y5P7MUD51
UPC 0195207155155
Application # M020
SPL Set ID 451b4d37-99e2-8e4f-e063-6294a90a51bb
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-15
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE; OCTINOXATE
Why two NDCs? The FDA registers this code as 85161-135-01 — 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 → 85161-0135-01. 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

LabelerLongway Technology(Guangzhou)Co.,Ltd.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code85161
First marketedJan 2026
Product typeHuman Otc Drug
Portfolio35 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 lotion sunscreen product formulated with two active ingredients that function as ultraviolet (UV) filters. Zinc oxide and octinoxate are both commonly used in over-the-counter sunscreen products to help protect skin from UV radiation. The product is marketed as an SPF 30 sunscreen and is available as a lotion intended for application to the face. This product is regulated under the FDA's over-the-counter monograph system for sunscreens.

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.

💊 What it looks like

Color yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 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 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 2EH13UN8D3
    A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • 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 88KCS7120E
    Ceramide 9 is a fatty lipid found naturally in skin. It's used in medicines as an emollient and skin-conditioning agent to help soften and protect the skin barrier in topical formulations.
  • UNII F1X8L2B00J
    A naturally derived fatty substance that helps bind and condition the product's texture. It works as an emollient and skin-conditioning agent in topical formulations, helping maintain moisture and smoothness.
  • UNII CR0J8RN66K
    A waxy, skin-like substance derived from plants or synthesized in labs. It's used in topical products as an emollient and skin barrier component to help keep the formula smooth and improve how it feels on skin.
  • UNII 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII 97C5T2UQ7J
    Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
  • UNII 39W1PKE3JI
    Bergamot oil is a citrus extract from bergamot orange peel. It's used as a flavoring and fragrance agent to improve taste and aroma in medicines.
  • 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 G3232Z5S2O
    A synthetic emollient and emulsifier derived from plant oils and glycerin. It helps blend oil and water components together and gives the product a smooth texture in topical formulations.
  • UNII X687XDK09L
    A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
  • UNII 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • 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 5EM498GW35
    A mixture of aromatic compounds used to add pleasant smell to the medicine. Fragrance helps mask unpleasant tastes or odors, making the medication easier to take.
  • 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 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • 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 HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII GIN46U9Q2Q
    Phytosphingosine is a naturally derived fatty compound that helps stabilize and thicken skincare and cosmetic formulations. It works as an emollient and conditioning agent to improve texture and skin feel in topical products.
  • UNII XRQ165498B
    A plant-derived emulsifier made from glycerin and oleic acid. It helps mix oil and water-based ingredients together in the formulation and improves product texture and stability.
  • UNII 687U3PEB2Y
    A complex emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients together and improves the texture and stability of creams, lotions, and other formulated products.
  • UNII Z570VEV8XK
    A synthetic silicone polymer used as a glidant and anti-caking agent. It reduces friction between particles so the medicine flows smoothly during manufacturing and remains free-flowing in the bottle.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII 7243K85WFO
    Sodium lauroyl lactylate is a mild surfactant derived from natural fats and lactic acid. It acts as an emulsifier and solubilizer to help blend oil and water-based ingredients and improve how the body absorbs the active drug.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII 930MLC8XGG
    A plant oil extracted from grape seeds, used as an emollient and solvent in medicines. It helps dissolve active ingredients and improve the texture and absorption of topical or 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.
  • 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.

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

The official label also statesC12-15 ALKYL BENZOATE, WATER, ETHYLHEXYL PALMITATE, ISODODECANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, BUTYLOCTYL SALICYLATE, ALCOHOL DENAT., COCOS NUCIFERA (COCONUT) OIL, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, PHENOXYETHANOL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, POLYGLYCERYL-3 OLEATE, POLYMETHYLSILSESQUIOXANE, NIACINAMIDE, DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE, DISTEARDIMONIUM HECTORITE, TOCOPHEROL, FRAGRANCE, BUTYROSPERMUM PARKII (SHEA) BUTTER, VITIS VINIFERA (GRAPE) SEED OIL, ETHYLHEXYLGLYCERIN, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, BHT, SODIUM LAUROYL LACTYLATE, CERAMIDE NP, CHOLESTEROL, CERAMIDE AP, PHYTOSPHINGOSINE, XANTHAN GUM, CARBOMER, CERAMIDE EOP

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 DailyMedingredient 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
Poolside Soft Serve Mineral Milk SPF 30 face sunscreen drops .21 g/g; .07 g/gthis 85161-0135-01 Longway 50 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

🏛️
2026
On the market since
Jan 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.

🔬 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 Zinc Oxide, Octinoxate — the ingredient across all brands.

Top reported reactions

Posture Abnormal3
Eye Movement Disorder2
Feeling Abnormal2
Petit Mal Epilepsy2
Seizure2
Staring2
Aggression1

Reporter sex

10 reports
Male · 10%
Female · 90%

Serious outcomes

Hospitalization2
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1 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
85161-0135-01 You're viewing this 50 g in 1 BOTTLE, PLASTIC (85161-135-01) 2026-01-15 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 85161-135-01, 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: 85161-0135-01, written without dashes as 85161013501. 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 85161-0135-01, the first segment (85161) is the labeler code FDA assigned to Longway Technology(Guangzhou)Co.,Ltd.; the middle segment (0135) 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 Longway Technology(Guangzhou)Co.,Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Longway Technology(Guangzhou)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 3 words

Helps prevent sunburn.

⏱️ Dosage and Administration 41 words

Directions Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Shake it up and down 3-5 seconds before use. Use a water resistant sunscreen if swimming or sweating. Children under 6 month: ask a doctor.

⚠️ Warnings 93 words

Warnings For external use only. Skin cancer/skin aging alert . Spending time in the sun increases your risk of skin cancer and early skin aging.

This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Do not use m on damaged or broken skin. When using this product keep out of eyes. rinse with water to remove.

Stop use and ask doctor if rash occurs. Keep out of reach of children. If product is swallowed get medical help or contact a poison center center night away,

🧪 Active Ingredient 5 words

Zinc Oxide 21%, Octinoxate 7%

🧪 Inactive Ingredients 74 words

C12-15 ALKYL BENZOATE, WATER, ETHYLHEXYL PALMITATE, ISODODECANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, BUTYLOCTYL SALICYLATE, ALCOHOL DENAT., COCOS NUCIFERA (COCONUT) OIL, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, PHENOXYETHANOL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, POLYGLYCERYL-3 OLEATE, POLYMETHYLSILSESQUIOXANE, NIACINAMIDE, DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE, DISTEARDIMONIUM HECTORITE, TOCOPHEROL, FRAGRANCE, BUTYROSPERMUM PARKII (SHEA) BUTTER, VITIS VINIFERA (GRAPE) SEED OIL, ETHYLHEXYLGLYCERIN, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, BHT, SODIUM LAUROYL LACTYLATE, CERAMIDE NP, CHOLESTEROL, CERAMIDE AP, PHYTOSPHINGOSINE, XANTHAN GUM, CARBOMER, CERAMIDE EOP

🎯 Purpose 1 words

Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.