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CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE 30 mg/mL; 90 mg/mL; 65 mg/mL Cream — NDC 58668-9918-01 package photo

CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE 30 mg/mL; 90 mg/mL; 65 mg/mL Cream

by Laboratoires Clarins · 1 JAR in 1 CARTON (58668-9918-1) / 50 mL in 1 JAR
NDC 58668-9918-01
🏷️ FDA NDC (as labeled) 58668-9918-1 billing pads the package 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) 58668-9918-1
Product NDC 58668-9918
11-digit billing NDC 58668991801
UNII G63QQF2NOX, V06SV4M95S, 5A68WGF6WM
Application # M020
SPL Set ID ae34fdcb-d372-435f-bf7c-075ea554b2fe
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-10-05
Route TOPICAL
Dosage form CREAM
Substance AVOBENZONE; HOMOSALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 58668-9918-1 — a 5-4-1 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 package segment → 58668-9918-01. 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

LabelerLaboratoires Clarins
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code58668
First marketedOct 2017
Product typeHuman Otc Drug
Portfolio14 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 cream sunscreen sold over the counter under FDA's monograph rules for sunscreen products. It contains three UV-filtering ingredients (avobenzone, homosalate, and octocrylene) that are typically used together to absorb and scatter ultraviolet rays from the sun. The product is formulated as a broad-spectrum sunscreen with SPF 15, meaning it is intended to help protect skin from both UVA and UVB radiation when applied to the face or body.

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 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 CZ67V4ZW0I
    A plant-derived oil from Balanites roxburghii seeds. It serves as an emollient and skin-conditioning agent in topical formulations, helping to soften and smooth the product's texture.
  • UNII 3SCV180C9W
    Betaine is a naturally occurring organic compound found in plants and animals. In medicines, it acts as an osmoprotectant and stabilizer, helping maintain the product's moisture balance and preserve its chemical stability during storage.
  • 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 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 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII 09FUA47KNA
    Cetearyl glucoside is a plant-derived surfactant made from vegetable oils and glucose. It helps oils and water mix together in creams and lotions, and can also soften and smooth the skin feel of the product.
  • 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 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 0R6X2JX6J1
    A plant extract from the leaf of Diospyros mespiliformis, a tree native to Africa. It may serve as a natural flavoring agent, colorant, or preservative in the medicine.
  • UNII 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 30QS0PF14U
    Furcelleran is a natural thickening and gelling agent derived from red seaweed. In medicines, it acts as a binder and stabilizer to give tablets their shape and help liquid formulations maintain consistent texture.
  • 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 3R963LO08T
    Kalanchoe pinnata is a plant extract used in some formulations as a natural flavoring agent or botanical ingredient. It may help provide taste or contribute to the product's overall composition.
  • UNII T9B77O7PZA
    A plant extract from common nipplewort flowering tops, used as a natural ingredient to add botanical content to the formulation. It may serve as a flavoring agent or contribute to the product's composition.
  • UNII 1X7L93686M
    A natural extract from acerola cherry seeds, used as a source of vitamin C and as an antioxidant to help protect the medicine's other ingredients from degradation during storage.
  • 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 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 Z6J799EAJK
    Oat is a cereal grain used in medicines as a filler and binder. It helps give the medication its shape and structure while adding bulk to the formulation.
  • 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 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 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 87GE52P74G
    Sea salt is sodium chloride harvested from seawater. It acts as a flavoring agent and preservative in medications, helping enhance taste and prevent microbial growth.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
  • 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 statesAQUA/WATER/EAU. GLYCERIN. BUTYLOCTYL SALICYLATE. BUTYROSPERMUM PARKII (SHEA) BUTTER. DIMETHICONE. C12-15 ALKYL BENZOATE. CETEARYL ALCOHOL. METHYL METHACRYLATE CROSSPOLYMER. POTASSIUM CETYL PHOSPHATE. PARFUM/FRAGRANCE. CETEARYL GLUCOSIDE. DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER. PHENOXYETHANOL. BUTYLENE GLYCOL. ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER. CAPRYLYL GLYCOL. TROMETHAMINE. AVENA SATIVA (OAT) KERNEL EXTRACT. DISODIUM EDTA. TOCOPHERYL ACETATE. XANTHAN GUM. DIMETHICONOL. TOCOPHEROL. ANIGOZANTHOS FLAVIDUS EXTRACT. CAPRYLIC/CAPRIC TRIGLYCERIDE. BETAINE. SILICA. SORBITOL. DIOSPYROS MESPILIFORMIS LEAF EXTRACT. MALTODEXTRIN. SANICULA EUROPAEA EXTRACT. SODIUM BENZOATE. KALANCHOE PINNATA LEAF EXTRACT. BALANITES ROXBURGHII SEED OIL. MITRACARPUS SCABER EXTRACT. CITRIC ACID. MALPIGHIA EMARGINATA (ACEROLA) SEED EXTRACT. LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT. FURCELLARIA LUMBRICALIS EXTRACT. CI 15985/YELLOW 6. POTASSIUM SORBATE. MARIS SAL/SEA SALT/SEL MARIN. [S3095A]

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
CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen 30 mg/mL; 90 mg/mL; 65 mg/mLthis 58668-9918-01 Laboratoires 1 jar — — 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

🏛️
2017
On the market since
Oct 2017
📍
2026
Currently FDA-listed
9 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 AVOBENZONE, HOMOSALATE, OCTOCRYLENE — the ingredient across all brands.

Top reported reactions

Rash14
Erythema12
Headache12
Sunburn11
Acne10
Dry Skin10
Application Site Erythema9

Age at onset

Child1
Adult9
Elderly11

Reporter sex

180 reports
Male · 35%
Female · 65%

Serious outcomes

Hospitalization27
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 15 3
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
58668-9918-01 You're viewing this 1 JAR in 1 CARTON (58668-9918-1) / 50 mL in 1 JAR 2017-10-05 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 58668-9918-1, 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: 58668-9918-01, written without dashes as 58668991801. 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 58668-9918-01, the first segment (58668) is the labeler code FDA assigned to Laboratoires Clarins; the middle segment (9918) 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 Laboratoires Clarins. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Laboratoires Clarins 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 31 words ▾

Uses: • helps prevent sunburn • 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 107 words ▾

Directions: • apply liberally 15 minutes before sun exposure • apply to all skin exposed to the sun • children under 6 months: Ask a doctor • Spending time in the sun in creases 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 • reapply at least every 2 hours • use a water resistant sun screen if swimming or sweating Sun Protection Measures.

⚠️ Warnings 60 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 occurs. Keep out of reach of children. If product is swallowed, get me dical help or contact a Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active ingredients AVOBENZONE 3% HOMOSALATE 9% OCTOCRYLENE 6.5% Purpose Sunscreen

🧪 Inactive Ingredients 145 words ▾

Inactive ingredients: AQUA/WATER/EAU . GLYCERIN . BUTYLOCTYL SALICYLATE .

BUTYROSPERMUM PARKII (SHEA) BUTTER . DIMETHICONE . C12-15 ALKYL BENZOATE .

CETEARYL ALCOHOL . METHYL METHACRYLATE CROSSPOLYMER . POTASSIUM CETYL PHOSPHATE .

PARFUM/FRAGRANCE . CETEARYL GLUCOSIDE . DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER .

PHENOXYETHANOL . BUTYLENE GLYCOL . ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER .

CAPRYLYL GLYCOL . TROMETHAMINE . AVENA SATIVA (OAT) KERNEL EXTRACT .

DISODIUM EDTA . TOCOPHERYL ACETATE . XANTHAN GUM .

DIMETHICONOL . TOCOPHEROL . ANIGOZANTHOS FLAVIDUS EXTRACT .

CAPRYLIC/CAPRIC TRIGLYCERIDE . BETAINE . SILICA .

SORBITOL . DIOSPYROS MESPILIFORMIS LEAF EXTRACT . MALTODEXTRIN .

SANICULA EUROPAEA EXTRACT . SODIUM BENZOATE . KALANCHOE PINNATA LEAF EXTRACT .

BALANITES ROXBURGHII SEED OIL . MITRACARPUS SCABER EXTRACT . CITRIC ACID .

MALPIGHIA EMARGINATA (ACEROLA) SEED EXTRACT . LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT . FURCELLARIA LUMBRICALIS EXTRACT .

CI 15985/YELLOW 6 . POTASSIUM SORBATE . MARIS SAL/SEA SALT/SEL MARIN. [S3095A]

🎯 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 ↗
← 58668-9818-01 · Laboratoires 58668-9920-01 · Laboratoires →
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.