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 152 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Binda Botanicals Baby and Kids Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED452b9b7d-4049-b483-e063-6394a90a53582025-12-04WarningsExact identifier
application number: M020
BINDA Face and Body Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386f5013-430c-e07f-e063-6394a90a32a82025-12-04WarningsExact identifier
application number: M020
Poolside Not Your Babys Oil. SPF 30 sunscreen body oil.HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bcb25-848c-e8a7-e063-6394a90ace0f2025-12-04WarningsExact identifier
application number: M020
Sugargirl Glowy face screen sunbeam shimmer sunscreen for the face SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd1d2-6a9f-f5e8-e063-6394a90ac9e32025-12-04WarningsExact identifier
application number: M020
Poolside Butter SCREEN SPF 30 sunscreen ButterHOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd24d-8654-e6c0-e063-6394a90a0aea2025-12-04WarningsExact identifier
application number: M020
Poolside Glow Butter Screen SPF 30 Shimmer sunscreen ButterHOMOSALATE , OCTOCRYLENE, OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd69e-02c7-fcbd-e063-6394a90ae59b2025-12-04WarningsExact identifier
application number: M020
Softlips CherryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybececc42-1321-430a-80ef-438060fdcc862025-12-04WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 WatermelonZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450d038b-3f99-add8-e063-6294a90aee9a2025-12-03WarningsExact identifier
application number: M020
Natrience Broad Spectrum SPF 30SKIN SHIELDSisel International, LLC1989370f-68a6-6f22-e063-6394a90aacaf2025-12-03Boxed warning, WarningsExact identifier
application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 CoconutZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450d8fd0-20ad-1920-e063-6394a90a72712025-12-03WarningsExact identifier
application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 ExoticZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450db2bb-1788-efc2-e063-6294a90a13c02025-12-03WarningsExact identifier
application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 WatermelonZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450dcc02-8bcb-6c07-e063-6394a90a5df42025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Face Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44acf513-ffe6-888c-e063-6394a90a9c5c2025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Baby Mineral Sunscreen Face Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450e52a9-5a6b-112f-e063-6394a90af7ca2025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450e6eb7-f49e-296e-e063-6294a90a05a42025-12-03WarningsExact identifier
application number: M020
Attitude - Leaves Bar - Lip Balm - SPF 15 - MangoZINC OXIDE9055-7588 Qubec Inc. DBA Attitude359a7ebf-46a6-4e99-b43c-f585e9bc08d92025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip balm Unscented SPF 15ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d95a2b7-288d-7b29-e063-6294a90ae46b2025-12-03WarningsExact identifier
application number: M020
Attitude - Lip Balm - SPF 15 - CoconutZINC OXIDEAttitude DBA 9055-7588 Qubec Inc.068af2ec-a666-45bf-b0e0-89d1b93dedf12025-12-03WarningsExact identifier
application number: M020
Cancer Council Invisible Fluid SPF50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.1629b02b-e9f3-0593-e063-6294a90a9aa52025-12-03WarningsExact identifier
application number: M020
PRO-TECT SPORTS SUNSCREENMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation16994959-cade-06de-e054-00144ff88e882025-12-03WarningsExact 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