FDA.reportPublic FDA data

4ocean REEF SAFE SUNSCREEN SPF 40

Product NDC
69555-040
11-digit product format
695550040
Labeler code
69555
Product ID
69555-040_5335f067-798b-90ad-e063-6294a90a0522
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Stream2Sea, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-27
Substance
ZINC OXIDE
Active strength
.2 g/80g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct69555-040UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69555-04069555-040-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
4ocean REEF SAFE SUNSCREEN SPF 40
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE.2 g/80g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
52d3d97c-a846-4721-acbe-52a525cb2011Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69555-040-014ocean REEF SAFE SUNSCREEN SPF 4080 g in 1 JARCREAM804
69555-040-034ocean REEF SAFE SUNSCREEN SPF 4080 g in 1 JARCREAM804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69555-0404OCEAN REEF SAFE SUNSCREEN SPF 40 (ZINC OXIDE) CREAM SPORT SUNSCREEN SPF40 (ZINC OXIDE) CREAM SOGGY DOLLAR ZINC SUN SCREEN SPF 40 (ZINC OXIDE) CREAM [STREAM2SEA, LLC]3Current NDC, 2 package rows20250519_52d3d97c-a846-4721-acbe-52a525cb2011.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 212 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ola Botanicals Sunscreen SPF 30ZINC OXIDENatural Health Partners, LLCc7a7df0b-da8f-407d-a1ee-28f75070b23c2025-06-02WarningsExact identifier
application number: M020
MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50ZINC OXIDEExpanscience Laboratories d/b/a Mustela95ea5442-a7ca-0c7d-e053-2a95a90ad2472025-06-02WarningsExact identifier
application number: M020
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC31f1e961-3719-f70a-e063-6394a90a481e2025-05-31WarningsExact identifier
application number: M020
Sunny Sailor First Mate Face Stick SPF 30ZINC OXIDESUNNY SAILOR LLC8ef7e0c8-e76b-4e84-ac9d-169f85e5e36e2025-05-28WarningsExact identifier
application number: M020
Dr Mercola Broad Spectrum SPF15ZINC OXIDENatural Health Partners, LLC47f6b19e-ede8-0daf-e054-00144ff88e882025-05-28WarningsExact identifier
application number: M020
Dr. Mercola Broad SpectrumZINC OXIDENatural Health Partners, LLC47f6ec0a-1144-55dd-e054-00144ff8d46c2025-05-28WarningsExact identifier
application number: M020
Dr. Mercola Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDENatural Health Partners, LLC47f6ab9e-fa73-496a-e054-00144ff8d46c2025-05-28WarningsExact identifier
application number: M020
Celavive Protective Day SPF 30AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENEUSANA Health Sciences, Inc.cf00763f-6b3e-4d50-b639-9a6d6f5959612025-05-28WarningsExact identifier
application number: M020
TALLOW SUNSCREENNON-NANO ZINC OXIDEFOUNDATION COMMERCE INC363e38bf-b4b4-dcc4-e063-6294a90a5d2f2025-05-28WarningsExact identifier
application number: M020
CoreTex SunX 50 FacestickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Products Inc364989ea-c93b-d404-e063-6294a90abd092025-05-28WarningsExact identifier
application number: M020
Solvaderm Universal Tinted Moisturizer Sunscreen SPF 30OCTINOXATE, ZINC OXIDESOLVADERM LLC86dbd8c3-e95a-49a8-afe6-ff9d985e28ba2025-05-27WarningsExact identifier
application number: M020
NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALMPort Jervis Laboratories, Inc.350b4cce-1627-5b8f-e063-6294a90aa6bf2025-05-26WarningsExact identifier
application number: M020
Protect Daily Ritual Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35ce8307-387b-2b40-e063-6294a90a28bc2025-05-23Exact identifier
application number: M020
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEPZINC OXIDEONESKIN INC.35d57d3f-376c-2307-e063-6294a90adf512025-05-23WarningsExact identifier
application number: M020
Oathology Inzincable Lip Balm SPF 35ZINC OXIDESKINOATH LLC289a5492-af57-42e5-82af-3f1e4b369d682025-05-22WarningsExact identifier
application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, LightZINC OXIDEALLI LLC3cb4459b-1776-414a-b5c4-0ffb9f1df7662025-05-22WarningsExact identifier
application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, DarkZINC OXIDEALLI LLC81633684-f9ac-45cb-8a3e-f0c30b229a822025-05-22WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bea4f3-c19e-3e2e-e063-6394a90aeb692025-05-22Exact identifier
application number: M020
LBEL FOREVER HYDRA LONGWEAR AND HYDRATING FOUNDATION 90H SPF 15 ALMENDRA 230NOCTINOXATE, ZINC OXIDEBEL STAR S.A.35c106b6-9a80-01e3-e063-6294a90abc352025-05-22WarningsExact identifier
application number: M020
COSRXAIRY-LIGHT CLEAR SUNCREEN STICKCOSRX inc.313b1a73-8863-c458-e063-6394a90a01d62025-05-20WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69555-040-016955500400180 g in 1 JAR (69555-040-01) 80 g2023-03-27NoNoCurrent
69555-040-036955500400380 g in 1 JAR (69555-040-03) 80 g2025-05-16NoNoCurrent