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Standard Procedure SPF 50 Sunscreen Homosalate, Octocrylene, Octisalate, Avobenzone 80 mg/mL; 30 mg/mL; 100 mg/mL; 50 mg/mL Lotion, 500 mL — NDC 84425-0101-04 package photo

Standard Procedure SPF 50 Sunscreen Homosalate, Octocrylene, Octisalate, Avobenzone 80 mg/mL; 30 mg/mL; 100 mg/mL; 50 mg/mL Lotion, 500 mL

by Standard Procedure Inc · 500 mL in 1 BOTTLE, PLASTIC (84425-101-04)
NDC 84425-0101-04
🏷️ FDA NDC (as labeled) 84425-101-04 billing pads the product segment with a zero
This package
Contains500 mL Pack sizes3 compare ↓
Also comes in: 60 ml 84425-0101-01 250 ml 84425-0101-03
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) 84425-101-04
Product NDC 84425-101
11-digit billing NDC 84425010104
UNII 5A68WGF6WM, G63QQF2NOX, V06SV4M95S, 4X49Y0596W
UPC 9358579000091
Application # M020
SPL Set ID 1d3f87de-90c0-75c0-e063-6394a90a2ef4
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-07-15
Route TOPICAL
Dosage form LOTION
Substance OCTOCRYLENE; AVOBENZONE; HOMOSALATE; OCTISALATE
Why two NDCs? The FDA registers this code as 84425-101-04 — 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 → 84425-0101-04. 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

LabelerStandard Procedure Inc
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84425
First marketedJul 2024
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?

Standard Procedure SPF 50 Sunscreen is a topical lotion containing four UV-filtering ingredients commonly used in sunscreen products. Homosalate, octisalate, and octocrylene are organic sunscreen agents that absorb ultraviolet radiation, while avobenzone is a broad-spectrum UV absorber. This OTC monograph product is formulated to provide sun protection when applied to skin.

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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform 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 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 XHK3U310BA
    Cyclohexasiloxane is a silicon-based liquid that acts as a solvent and conditioning agent in medicines. It helps dissolve or carry other ingredients and improves how the product spreads or feels on the skin.
  • 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 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 8CRQ2TH63M
    Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII I629I3NR86
    A natural flavoring derived from mango fruit, used to add taste and aroma to medicines. It helps mask bitter or unpleasant flavors, making the medication more pleasant to take.
  • UNII KU94FIY6JB
    A natural enzyme extract from papaya fruit that helps break down proteins. It's used in some medicines as a digestive aid ingredient and may help tablets dissolve or break apart in the stomach.
  • UNII 3C1QUF1TIR
    A waxy substance made from beeswax combined with polyethylene glycol. It acts as an emulsifier and thickener to help mix ingredients and give the medicine its proper texture and consistency.
  • 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 YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • 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 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.

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

The official label also statesBEESWAX, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, ISOPROPYL PALMITATE, CYCLOHEXASILOXANE, CETEARETH-20, ALOE BARBADENSIS LEAF JUICE, ANANAS SATIVUS (PINEAPPLE) FRUIT EXTRACT, BENZYL ALCOHOL, CARBOMER, CARICA PAPAYA (PAPAYA) FRUIT EXTRACT, CITRIC ACID, GLYCERIN, HYDROXYACETOPHENONE, MALTODEXTRIN, MANGIFERA INDICA (MANGO) FRUIT EXTRACT, SODIUM STEAROYL GLUTAMATE, TOCOPHERYL ACETATE, TRIETHANOLAMINE, PHENOXYETHANOL, WATER

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.
Try another pack size: 60 ml 250 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Standard Procedure SPF 50 Sunscreen 80 mg/mL; 30 mg/mL; 100 mg/mL; 50 mg/mLthis 84425-0101-04 Standard 500 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

🏛️
2024
On the market since
Jul 2024
📍
2026
Currently FDA-listed
2 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 Homosalate, Octocrylene, Octisalate, Avobenzone — the ingredient across all brands.

Top reported reactions

Application Site Burn1
Hypersensitivity1

Reporter sex

2 reports
Female · 100%
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
84425-0101-01 60 mL in 1 BOTTLE, PLASTIC (84425-101-01) 2024-07-15 Active
84425-0101-03 250 mL in 1 BOTTLE, PLASTIC (84425-101-03) 2024-07-15 Active
84425-0101-04 You're viewing this 500 mL in 1 BOTTLE, PLASTIC (84425-101-04) 2024-07-15 Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 84425-0101-04?
NDC 84425-0101-04 contains 500 mL — 500 ml in 1 bottle, plastic.
What is the difference between NDC 84425-0101-04 and NDC 84425-0101-01?
Both are Standard Procedure SPF 50 Sunscreen Homosalate, Octocrylene, Octisalate, Avobenzone 80 mg/mL; 30 mg/mL; 100 mg/mL; 50 mg/mL Lotion — the drug itself is identical. NDC 84425-0101-04 is the 500 mL package, while NDC 84425-0101-01 is the 60 ml package.
What NDC number is used to bill for this package of Standard Procedure SPF 50 Sunscreen Homosalate, Octocrylene, Octisalate, Avobenzone 80 mg/mL; 30 mg/mL; 100 mg/mL; 50 mg/mL Lotion?
Bill NDC 84425-0101-04 — the 11-digit billing format is 84425010104. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 84425-101-04, 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: 84425-0101-04, written without dashes as 84425010104. 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 84425-0101-04, the first segment (84425) is the labeler code FDA assigned to Standard Procedure Inc; the middle segment (0101) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Standard Procedure Inc. 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 2 other package presentations of this same product, including 60 ml (84425-0101-01), 250 ml (84425-0101-03). 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?
Standard Procedure 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 29 words ▾

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

⏱️ Dosage and Administration 91 words ▾

Directions Apply generously and evenly 15 minutes before sun exposure Reapply at least every 80 minutes Usa a water resistant sunscreen if swimming or sweating Sun Protection Measures. Speading time in the sun increases your risk of skin cancer and early skin aging. To decres this risk, regularly usa a sunscreen with broad spectum SPF of 15 or higher and other sun protection measures including: Limit time in thee sun, especially from 10 a.m. - 2 p.m, wear long-sleeve shirts, pants, hats and sunglasses, children under 6 months: Ask a doctor

⚠️ Warnings 59 words ▾

Warnings For external use only Do not use on damaged orbroken skin Stop use and ask a doctor if rash occurs When using this product keep out of eyes Rinse with water to remove Keep out of reach of children Keep out of reach of children . If swallowed, get medical help or contact Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active Ingredients Homosalate 10% Octocrylene 8% Octisalate 5% Avobenzone 3%

🧪 Inactive Ingredients 45 words ▾

Inactive Ingredients BEESWAX, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, ISOPROPYL PALMITATE, CYCLOHEXASILOXANE, CETEARETH-20, ALOE BARBADENSIS LEAF JUICE, ANANAS SATIVUS (PINEAPPLE) FRUIT EXTRACT, BENZYL ALCOHOL, CARBOMER, CARICA PAPAYA (PAPAYA) FRUIT EXTRACT, CITRIC ACID, GLYCERIN, HYDROXYACETOPHENONE, MALTODEXTRIN, MANGIFERA INDICA (MANGO) FRUIT EXTRACT, SODIUM STEAROYL GLUTAMATE, TOCOPHERYL ACETATE, TRIETHANOLAMINE, PHENOXYETHANOL, WATER

🎯 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 ↗
← 84423-0090-01 · Guangzhou 84425-0105-05 · Standard →
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.