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ALLIES OF SKIN The One SPF-50 Invisible Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE 30 mg/mL; 70 mg/mL; 100 mg/mL; 50 mg/mL Gel — NDC 83852-0438-50 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ALLIES OF SKIN The One SPF-50 Invisible Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE 30 mg/mL; 70 mg/mL; 100 mg/mL; 50 mg/mL Gel — NDC 83852-438-50 (Billing 83852-0438-50)

by ALLIES GROUP PTE. LTD. · 1 TUBE in 1 BOX / 50 mL in 1 TUBE

This is a package of ALLIES OF SKIN The One SPF-50 Invisible Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE 30 mg/mL; 70 mg/mL; 100 mg/mL; 50 mg/mL Gel from ALLIES GROUP PTE. LTD., marketed since Dec 2023 and currently FDA-listed.

NDC 83852-0438-50
🏷️ FDA NDC (as labeled) 83852-438-50 billing pads the product segment with a zero
This package
Contains50 mL in 1 tube Pack sizes4 compare ↓
Product page 83852-0438-03 Also comes in: 20 mL 83852-438-20 90 mL 83852-438-90 3 ml 83852-438-03
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 83852-438-50 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
83852 labeler · 438 product · 50 package
Package marketed since
Dec 11, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
8885014070032, 8885014073224, 8885014075853
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83852-438-50
Product NDC 83852-438
11-digit billing NDC 83852043850
UNII G63QQF2NOX, V06SV4M95S, 5A68WGF6WM, 4X49Y0596W
UPC 8885014070032, 8885014073224, 8885014075853
Application # M020
SPL Set ID 36e1c61c-33ab-4a5d-853d-119c29632b08
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-11
Route TOPICAL
Dosage form GEL
Substance AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Why two NDCs? The FDA registers this code as 83852-438-50 — 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 → 83852-0438-50. 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.

Clinical

🧪 What is this product?

This is a topical gel sunscreen marketed as an over-the-counter monograph product. It contains four UV-filtering ingredients (avobenzone, homosalate, octisalate, and octocrylene) that are commonly used together in sunscreens to absorb and scatter ultraviolet radiation from the sun. The gel formulation is applied directly to the skin and is typically used to help protect against 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.

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.
Try another pack size: 20 mL 90 mL 3 ml
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
83852-0438-03 83852-438-03 Main listing 3 mL in 1 PACKET Sample 2023-12-11 — Active
83852-0438-50 You're viewing this 1 TUBE in 1 BOX / 50 mL in 1 TUBE 2023-12-11 — Active
83852-0438-20 83852-438-20 1 TUBE in 1 BOX / 20 mL in 1 TUBE 2024-06-19 — Active
83852-0438-90 83852-438-90 1 TUBE in 1 BOX / 90 mL in 1 TUBE 2025-05-15 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 box / 50 ml in 1 tube.
What NDC number is used to bill for this package of ALLIES OF SKIN The One SPF-50 Invisible Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE 30 mg/mL; 70 mg/mL; 100 mg/mL; 50 mg/mL Gel?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
ALLIES OF SKIN The One SPF-50 Invisible Sunscreen 30 mg/mL; 70 mg/mL; 100 mg/mL; 50 mg/mLthis 83852-0438-50 ALLIES 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

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 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.

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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • 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 L56Z1JK48B
    A vegetable-derived ingredient used primarily as a natural colorant and flavoring agent in medicines. It provides orange-yellow color and mild taste to tablets, capsules, or liquids.
  • UNII O4I3UFO6ZF
    A silicone-based polymer blend that acts as an emulsifier and texture modifier. It helps keep oil and water mixed together in the formulation and gives the product a smooth, spreadable consistency.
  • UNII 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII BKJ0J3D1BP
    A plant-derived ingredient from sunflower flowers, used as a natural colorant and flavoring agent in medicines. It may help provide color or mild taste to the product.
  • 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 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 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 CLV24I3T1D
    A plant extract from pomegranate root bark used as a natural coloring agent and flavoring component in medicines. It may also help preserve the product and provide mild astringent properties to the formulation.
  • UNII IJ67X351P9
    A natural plant extract from rosemary leaves used as a preservative to help prevent oils and fats in the medicine from spoiling or becoming rancid during storage.
  • UNII 9LBV3F07AZ
    A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during storage.
  • 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 AZQ08K38Z1
    A synthetic oily liquid derived from salicylic acid. It works as an emollient and penetration enhancer in topical formulations, helping active ingredients absorb into skin while conditioning and softening the application area.
  • UNII 231473QB6R
    Watermelon is a fruit extract or flavoring agent. It's added to medicines to improve taste, making the product more palatable, especially for children or medications with unpleasant flavors.

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

The official label also statesIsododecane, Dimethicone/bis-lsobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Tridecyl Salicylate, Aloe Barbadensis Leaf Extract, Camellia Sinensis (Green Tea) Extract, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Extract, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Punica Granatum (Pomegranate) Extract, Rosmarinus Officinalis (Rosemary)  Extract, Rubus Idaeus (Raspberry) Oil, Niacinamide, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopherol (Vitamin E)

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.

Manufacturer & labeler

LabelerALLIES GROUP PTE. LTD.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83852
First marketedDec 2023
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from ALLIES GROUP PTE. LTD. labeler code 83852

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.

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 38 words ▾

Uses: • Helps prevent sunburn. • Higher SPF gives sunburn protection. • If used as directed with other sun protection measures (see Directions) , decreases the risk of skin cancer and early skin aging caused by the sun.

⏱️ Dosage and Administration 102 words ▾

Directions: • Apply liberally 15 minutes before sun exposure and as needed. • children under 6 months of age: ask a doctor.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 broad spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. – 2 p.m. • Wear long-sleeved shirts, pants, hats and sunglasses.

⚠️ Warnings 71 words ▾

Warnings: For external use only. Do not use • on damaged or broken skin. When using this product • keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if • rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.

🧪 Active Ingredient 12 words ▾

Active Ingredients Avobenzone 3.00%, Homosalate 7.00%, Octocrylene 10.00%, Octisalate 5.00% Purpose Sunscreen

🧪 Inactive Ingredients 58 words ▾

Inactive Ingredients: Isododecane, Dimethicone/bis-lsobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Tridecyl Salicylate, Aloe Barbadensis Leaf Extract, Camellia Sinensis (Green Tea) Extract, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Extract, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Punica Granatum (Pomegranate) Extract, Rosmarinus Officinalis (Rosemary) Extract, Rubus Idaeus (Raspberry) Oil, Niacinamide, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopherol (Vitamin E)

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 9 words ▾

Do not use • on damaged or broken skin.

📄 When Using This Product 14 words ▾

When using this product • keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 14 words ▾

Stop use and ask a doctor if • rash or irritation develops and lasts.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 24 words ▾

Package Labeling:50ml Outer Package0 Inner Package0

Package Labeling:3ml Label

Package Labeling: 20ml Outer Package02 Inner Package02

Package Labeling:90ml Outer Package 03 Inner Package 03

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

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 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE — the ingredient across all brands.

Top reported reactions

Rash14
Erythema11
Acne10
Dry Skin10
Sunburn9
Malignant Melanoma8
Condition Aggravated7

Age at onset

Child1
Adult9
Elderly11

Reporter sex

146 reports
Male · 34%
Female · 66%

Serious outcomes

Hospitalization22
Death6
Disabling3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 14 1
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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 ALLIES GROUP PTE. LTD.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1 tube (83852-0438-20), 1 tube (83852-0438-90), 3 ml (83852-0438-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
ALLIES GROUP PTE. 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.
← 83851-0100-05 · Vistamerica 83852-0543-00 · ALLIES →
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.