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Societe Prime and Defend Zinc Oxide Sunscreen 10 g/100g; 4 g/100g Cream, 57 g — NDC 87700-0539-01 package photo

Societe Prime and Defend Zinc Oxide Sunscreen 10 g/100g; 4 g/100g Cream, 57 g

by Societe Clinical Skincare · 57 g in 1 TUBE (87700-539-01)
NDC 87700-0539-01
🏷️ FDA NDC (as labeled) 87700-539-01 billing pads the product 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) 87700-539-01
Product NDC 87700-539
11-digit billing NDC 87700053901
UNII 15FIX9V2JP, SOI2LOH54Z
UPC 0882898012194
Application # M020
SPL Set ID 5439bd31-5ee1-9bca-e063-6394a90a748c
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-11-01
Route TOPICAL
Dosage form CREAM
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 87700-539-01 — 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 → 87700-0539-01. 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

LabelerSociete Clinical Skincare
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code87700
First marketedNov 2024
Product typeHuman Otc Drug
Portfolio5 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?

Societe Prime and Defend is a topical cream sunscreen marketed as an over-the-counter monograph product. It contains titanium dioxide and zinc oxide, which are mineral UV filters commonly used to block and scatter ultraviolet light from the sun. These inorganic ingredients are typically included in sunscreen products to help protect skin from sun exposure when applied to the skin surface.

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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • 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 J5VFA9V6YG
    A waxy, fatty substance derived from behenic acid. It works as a lubricant and glidant to help powder particles flow smoothly during tablet manufacturing and prevent sticking.
  • 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 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 CZ227117JE
    A silicone-based compound made of linked silicon and oxygen atoms arranged in a ring structure. It acts as a solvent, carrier, or conditioning agent to help distribute active ingredients evenly and improve product texture and spreadability.
  • 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 OSA9UP217S
    Dimethiconol is a silicone-based lubricant and anti-foaming agent. It reduces friction between tablet components and prevents foam formation during manufacturing and storage.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII O0CV1RMR44
    A dark pigment made synthetically from tyrosine and peroxide. It's used as a colorant in tablets and capsules to give medicines their color and help distinguish different dosages visually.
  • UNII 6777U11MKT
    A silicone-based lubricant and anti-foaming agent used to reduce surface tension and prevent foam formation during manufacturing and storage of the medication.
  • UNII EG97988M5Q
    A synthetic plastic polymer that forms a three-dimensional network. It's used as a coating on tablets and capsules to control how fast the medicine releases into the body, or as a binder to hold pill ingredients together.
  • UNII 287GF3Y3WC
    PEG-10 Dimethicone is a silicone-based compound that acts as an emulsifier and surfactant in medicines. It helps blend water and oil-based ingredients together and reduces surface tension to improve how the product spreads and feels.
  • UNII 01S2G2C1E4
    Sorbitan isostearate is an emulsifier derived from sorbitol and isostearic acid. It helps mix oil and water-based ingredients together and keeps them blended throughout the medicine's shelf life.
  • UNII 8OC9U7TQZ0
    Tribehenin is a waxy, plant-derived substance that acts as a lubricant and glidant in tablets and capsules. It helps the medicine flow smoothly during manufacturing and prevents sticking during production and packaging.

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

The official label also statesCyclopentasiloxane Dimethicone Crosspolymer Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer Dimethicone/Vinyl Dimethicone Crosspolymer Melanin Tribehenin Calcium Behenate Sorbitan Isostearate Dimethiconol Cyclotetrasiloxane Alumina PEG-10 Dimethicone Methicone Camellia Sinensis Leaf Extract Iron Oxide

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
Societe Prime and Defend 10 g/100g; 4 g/100gthis 87700-0539-01 Societe 57 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

🏛️
2024
On the market since
Nov 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 Societe Prime and Defend (this brand).

Top reported reactions

Dry Skin1
Erythema1
Pruritus1
Skin Discomfort1
Skin Exfoliation1
Skin Fissures1
Skin Irritation1

Reporter sex

1 reports
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
87700-0539-01 You're viewing this 57 g in 1 TUBE (87700-539-01) 2024-11-01 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 87700-539-01, 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: 87700-0539-01, written without dashes as 87700053901. 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 87700-0539-01, the first segment (87700) is the labeler code FDA assigned to Societe Clinical Skincare; the middle segment (0539) 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 Societe Clinical Skincare. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Societe Clinical Skincare 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 15 words ▾

Uses Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn.

⏱️ Dosage and Administration 27 words ▾

Directions Apply evenly to skin before exposure to sun and as needed. Children under 6 months, ask doctor. Reapply as needed or after towel drying or swimming

⚠️ Warnings 43 words ▾

Warnings For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if rash and irritation develops and lasts. Avoid contact with eyese. If product gets into eyes, rinse thoroughly with water.

🧪 Active Ingredient 8 words ▾

Active Ingredients Titanium Dioxide 10.60% Zinc Oxide 3.85%

🧪 Inactive Ingredients 30 words ▾

Inactive Ingredients Cyclopentasiloxane Dimethicone Crosspolymer Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer Dimethicone/Vinyl Dimethicone Crosspolymer Melanin Tribehenin Calcium Behenate Sorbitan Isostearate Dimethiconol Cyclotetrasiloxane Alumina PEG-10 Dimethicone Methicone Camellia Sinensis Leaf Extract Iron Oxide

🎯 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 ↗
← 87700-0529-30 · Societe 87702-0141-01 · Elaine →
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.