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No7 Restore and Renew Face and Neck Multi Action Day Cream Sunscreen Broad Spectrum SPF 30 Avobenzone, Octisalate, Octocrylene 1.5 g/25mL; 4 g/25mL; 2.5 g/25mL Cream

by BCM Cosmetique SAS · 1 TUBE in 1 BOX (61589-9101-3) / 25 mL in 1 TUBE
NDC 61589-9101-03
🏷️ FDA NDC (as labeled) 61589-9101-3 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 61589-9101-3
Product NDC 61589-9101
11-digit billing NDC 61589910103
UNII G63QQF2NOX, 5A68WGF6WM, 4X49Y0596W
Application # M020
SPL Set ID 3f0500cc-013b-7069-e063-6294a90a1a5f
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-04-30
Route TOPICAL
Dosage form CREAM
Substance AVOBENZONE; OCTOCRYLENE; OCTISALATE
Why two NDCs? The FDA registers this code as 61589-9101-3 — 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 → 61589-9101-03. 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

LabelerBCM Cosmetique SAS
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code61589
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio72 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 OTC monograph rules. It contains three active ingredients (avobenzone, octisalate, and octocrylene) that function as ultraviolet light filters, commonly used in sunscreen products to help protect skin from UVA and UVB sun exposure. The cream is formulated for application to the face and neck and includes a sun protection factor (SPF) of 30.

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.

💊 What it looks like

Color white
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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
No7 Restore and Renew Face and Neck Multi Action Day Cream Sunscreen Broad Spectrum SPF 30 1.5 g/25mL; 4 g/25mL; 2.5 g/25mLthis 61589-9101-03 BCM 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

🏛️
2024
On the market since
Apr 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 Avobenzone,Octisalate, Octocrylene. — the ingredient across all brands.

Top reported reactions

Rash3
Skin Cancer3
Application Site Burn2
Hypersensitivity2
Product Expiration Date Issue2
Product Lot Number Issue2
Acne1

Age at onset

Adult1
Elderly2

Reporter sex

20 reports
Male · 12%
Female · 88%

Serious outcomes

Hospitalization1
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2 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
61589-9101-03 You're viewing this 1 TUBE in 1 BOX (61589-9101-3) / 25 mL in 1 TUBE 2024-04-30 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 61589-9101-3, 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: 61589-9101-03, written without dashes as 61589910103. 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 61589-9101-03, the first segment (61589) is the labeler code FDA assigned to BCM Cosmetique SAS; the middle segment (9101) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 BCM Cosmetique SAS. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
BCM Cosmetique SAS 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 and Cautions ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📋 Description 💬 Information for Patients
🎯 Indications and Usage 92 words ▾

Directions Directions apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. 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 a Broad Spectrum SPF value 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.

⏱️ Dosage and Administration 92 words ▾

Directions Directions apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. 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 a Broad Spectrum SPF value 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 and Cautions 26 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.

⚠️ Warnings 26 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.

📦 Storage and Handling 19 words ▾

Storage Other information protect the product in this container from excessive heat and direct sun avoid contact with fabrics

🧪 Active Ingredient 12 words ▾

Carton Active Ingredients Section Active ingredients Avobenzone 3% Octisalate 5% Octocrylene 8%

🧪 Inactive Ingredients 127 words ▾

Inactive ingredients Aqua (Water), C12-15 alkyl benzoate, Glycerin, Alcohol denat., Tribehenin, Butylene glycol, Aluminum starch octenylsuccinate, Dimethicone, Cetearyl alcohol, Cetearyl glucoside, Butyrospermum parkii (Shea) butter, Ammonium acryloydimethyltaurate/VP copolymer, Cetearyl glucoside, Silica, Phenoxyethanol, Potassium cetyl phosphate, Methylparaben, Parfum (Fragrance), Propylene glycol, Xanthan gum, Ethylparaben, Hibiscus abelmoschus extract, Retinyl palmitate, Simethicone, Hydrolyzed hyaluronic acid, Tetrasodium EDTA, Cetyl alcohol, Stearyl alcohol, Dipropylene glycol, Hydrolyzed rice protein, Sorbitan laurate, Polysorbate 20, T-butyl alcohol, Panax ginseng root extract, Sodium lauroyl lactylate, Phyllanthus emblica fruit extract, Carbomer, Calcium hydroxymethionine, 3-aminopropane sulfonic acid, Hydroxyethylcellulose, Potassium hydroxide, Dimethylmethoxy chromanol, Acetyl dipeptide-1 cetyl ester, Morus alba leaf extract, Ceramide NP, Ceramide AP, Sodium benzoate, Phytosphingsine, Cholesterol, Ethylhexylglycerin, Tocopherol, Palmitoyl tripeptide-1, Palmitoyl tetrapeptide-7, Ceramide EOP, CI 77891 (Titanium dioxide), CI 77491 (Iron oxides), CI 14700 (Red 4).

🎯 Purpose 5 words ▾

Uses Uses helps prevent sunburn

📋 Description 129 words ▾

Description No7 Restore & Renew FACE & NECK MULTI ACTION Anti-Ageing Skincare System 5 key age defying results for FACE & NECK: Noticeably firmer feeling skin Wrinkles appear visbly reduced A more even looking skin tone Neck looks visibly smoother and feels noticeably firmer Younger looking skin 50 ml e

1.69Fl.Oz. Day Cream: MULTI ACTION results, all day hydration for visibly younger looking skin. Combining the protective power of SPF 30, our unique Double Defence technology and our No7 age defying ingredients.

The perfect partner to your No7 Restore & Renew MULTI ACTION serum, this day cream works to visibly reduce the appearance of 5 key signs of ageing: skin feels firmer, wrinkles appear visibly reduced, neck looks visibly smoother and feels noticeably firmer, skin is intensely moisturized.

💬 Information for Patients 29 words ▾

USA: Questions? 1-866-75-BOOTS Made in the UK The Boots Company PLC Nottingham England NG2 3AA Dist. in the USA by Boots Retail USA Inc. New York NY 10005 www.no7beauty.com

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61589-0251-01 · BCM 61589-9102-07 · BCM →
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.