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4ocean REEF SAFE SUNSCREEN SPF 40 Zinc Oxide .2 g/80g Cream, 80 g — NDC 69555-0040-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

4ocean REEF SAFE SUNSCREEN SPF 40 Zinc Oxide .2 g/80g Cream, 80 g — NDC 69555-040-01 (Billing 69555-0040-01)

by Stream2Sea, LLC · 80 g in 1 JAR

This is a package of 80 g of 4ocean REEF SAFE SUNSCREEN SPF 40 Zinc Oxide .2 g/80g Cream from Stream2Sea, LLC, marketed since Mar 2023 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 69555-0040-01
🏷️ FDA NDC (as labeled) 69555-040-01 billing pads the product segment with a zero
This package
Contains80 g Pack sizes2 compare ↓
Main listing for product 69555-040 · Also comes in: 80 g 69555-040-03
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 69555-040-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69555 labeler · 040 product · 01 package
Package marketed since
Mar 27, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0851061006674, 0850049973007, 0851061006346
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69555-040-01
Product NDC 69555-040
11-digit billing NDC 69555004001
UNII SOI2LOH54Z
UPC 0851061006674, 0850049973007, 0851061006346
Application # M020
SPL Set ID 52d3d97c-a846-4721-acbe-52a525cb2011
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 2023-03-27
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 69555-040-01 — 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 → 69555-0040-01. 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.

Clinical

🧪 What is this product?

This is a topical cream sunscreen containing zinc oxide, an over-the-counter monograph drug product. Zinc oxide is a mineral UV filter that is commonly used in sunscreens to help protect skin from ultraviolet radiation. The product is marketed as reef-safe, indicating it is formulated without certain chemical ingredients that may harm coral ecosystems. This cream is intended for application to exposed skin.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

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: 80 g
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
69555-0040-01 You're viewing this Main listing 80 g in 1 JAR 2023-03-27 — Active
69555-0040-03 69555-040-03 80 g in 1 JAR 2025-05-16 — Active

Pack size FAQ

What quantity is in this package?
This package contains 80 g — 80 g in 1 jar.
How does this package differ from NDC 69555-0040-03?
Both are 4ocean REEF SAFE SUNSCREEN SPF 40 Zinc Oxide .2 g/80g Cream — the drug itself is identical. This page's package is the 80 g one, while NDC 69555-0040-03 is the 80 g package.
What NDC number is used to bill for this package of 4ocean REEF SAFE SUNSCREEN SPF 40 Zinc Oxide .2 g/80g Cream?
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
4ocean REEF SAFE SUNSCREEN SPF 40 .2 g/80gthis 69555-0040-01 Stream2Sea, 80 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

🏛️
2023
On the market since
Mar 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 66YXD4DKO9
    A natural oil extracted from almond kernels. It's used in medicines as an emollient and solvent to help dissolve or suspend active ingredients and improve texture in topical and oral formulations.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • 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 MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • 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 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

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

The official label also states4OCEAN REEF SAFE SUNSCREEN SPF 40 Prunus Amygdalus Dulcis (Sweet Almond) Oil, Helianthus Annuus (Sunflower) Seed Oil, Cera Alba (Beeswax), Jojoba Esters, Sorbitan Olivate, Polyhydroxystearic Acid, Squalane (Plant-Based), Silica, Mixed Tocopherols (Vitamin E). SPORT SUNSCREEN SPF 40 Prunus Amygdalus Dulcis (Sweet Almond) Oil, Extracts of Camellia Sinensis (Green Tea) Leaf *, Ocimum Tenuiflorum (Tulsi)Leaf *, Alaria Esculenta (Wakame Seaweed) * and Olea Europaea (Olive) Leaf * in Helianthus Annuus (Sunflower) Seed Oil, Cera Alba (Beeswax), Jojoba Esters, Sorbitan Olivate, Polyhydroxystearic Acid, Squalane (Plant-Based), Silica, Mixed Tocopherols (Vitamin E) * CERTIFIED ORGANIC INGREDIENTS. SOGGY DOLLAR ZINC SUNSCREEN SPF 40 Sweet Almond Oil, Extracts of Chamomile* and Calendula* in Sunflower Seed Oil, Beeswax, Jojoba Esters, Sorbitan Olivate, Polyhydroxystearic Acid, Squalane (Plant-Based), Silica, Fragrance (Naturally-Derived), Vitamin E *CERTIFIED ORGANIC INGREDIENTS. Other Information for SOGGY DOLLAR ZINC SUNSCREEN SPF 40 The most renowned oceanfront bar Soggy Dollar has joined forces with the most rigorously tested suncare brand Stream2Sea to safeguard both your skin and our environment. This ecoconscious collaboration has created a safe sunscreen for you, your family and the planet. Manufactured in the USA by: Stream2Sea, LLC Bowling Green, FL 33834  Questions: 866-960-9513  Stream2Sea.com

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

LabelerStream2Sea, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code69555
First marketedMar 2023
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.

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 4 words ▾

Uses Helps prevent sunburn

⏱️ Dosage and Administration 50 words ▾

Directions Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours. For children under 6 months of age; ask a doctor. Wear UPF clothing and apply to exposed skin in small amounts to start.

⚠️ Warnings 44 words ▾

Warnings For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes, rinse with water to remove. Keep babies and young children out of direct sunlight.

🧪 Active Ingredient 40 words ▾

DRUG FACTS Products Name Active Ingredients 4OCEAN REEF SAFE SUNSCREEN SPF 40 20% Zinc Oxide (Non-Nano) SPORT SUNSCREEN SPF 40 20% Zinc Oxide(Non-Nano EcoSafe Zinc ™ ) SOGGY DOLLAR ZINC SUNSCREEN SPF 40 20% Zinc Oxide (Non-Nano EcoSafe TM Zinc)

🧪 Inactive Ingredients 195 words ▾

Inactive Ingredients 4OCEAN REEF SAFE SUNSCREEN SPF 40 Prunus Amygdalus Dulcis (Sweet Almond) Oil, Helianthus Annuus (Sunflower) Seed Oil, Cera Alba (Beeswax), Jojoba Esters, Sorbitan Olivate, Polyhydroxystearic Acid, Squalane (Plant-Based), Silica, Mixed Tocopherols (Vitamin E). SPORT SUNSCREEN SPF 40 Prunus Amygdalus Dulcis (Sweet Almond) Oil, Extracts of Camellia Sinensis (Green Tea) Leaf * , Ocimum Tenuiflorum (Tulsi)Leaf * , Alaria Esculenta (Wakame Seaweed) * and Olea Europaea (Olive) Leaf * in Helianthus Annuus (Sunflower) Seed Oil, Cera Alba (Beeswax), Jojoba Esters, Sorbitan Olivate, Polyhydroxystearic Acid, Squalane (Plant-Based), Silica, Mixed Tocopherols (Vitamin E) * CERTIFIED ORGANIC INGREDIENTS.

SOGGY DOLLAR ZINC SUNSCREEN SPF 40 Sweet Almond Oil, Extracts of Chamomile* and Calendula* in Sunflower Seed Oil, Beeswax, Jojoba Esters, Sorbitan Olivate, Polyhydroxystearic Acid, Squalane (Plant-Based), Silica, Fragrance (Naturally-Derived), Vitamin E *CERTIFIED ORGANIC INGREDIENTS. Other Information for SOGGY DOLLAR ZINC SUNSCREEN SPF 40 The most renowned oceanfront bar Soggy Dollar has joined forces with the most rigorously tested suncare brand Stream2Sea to safeguard both your skin and our environment. This ecoconscious collaboration has created a safe sunscreen for you, your family and the planet.

Manufactured in the USA by: Stream2Sea, LLC Bowling Green, FL 33834 Questions: 866-960-9513 Stream2Sea.com

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Package Label / Principal Display Panel 33 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 4Ocean Reef Safe Sunscreen SPF 40 - Jar Label Sport Sunscreen SPF 40 Jar Label Soggy Dollar Sinc Sunscreen SPF 40 Jar Label label label image description sport-sunscreen-spf-40-labels soggydollar-spf-40-labels

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 4ocean REEF SAFE SUNSCREEN SPF 40 (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Age at onset

Neonate5
Infant8
Child28
Adolescent5
Adult110
Elderly192

Reporter sex

1,941 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization988
Death204
Life-threatening116
Disabling32
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 229 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.

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 Stream2Sea, LLC. 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 1 other package presentation of this same product, including 80 g (69555-0040-03). 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?
Stream2Sea, LLC 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.
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.