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 343 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm IvoryOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS97e7ece8-a705-4988-ba52-6d3f115735212021-12-01WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 ChestnutOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS6a44f926-11b4-4bc4-8d5d-721a89c4f0cc2021-11-09WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 HazelnutOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASb58af664-b0fd-4585-8417-7c20954d7aff2021-11-09WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 UmberOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS7bbd1334-fae8-4274-b927-a099af7643452021-11-09WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 CedarOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS970571f9-3d6b-46ae-a668-745de1911fa22021-11-09WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 WheatOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS542e1b2e-f63c-466b-b5ac-6c147a0e9dec2021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm BeigeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS21b65c12-6f67-4053-9508-6b2709cc1fb82021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool BeigeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS8ea4c470-ebd5-448e-b72a-ccd1113de0ab2021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 HoneyOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASfd9689a4-21d1-49f0-bf59-b8e1da72cd162021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 DuneOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASc23b6a87-8cf9-4be3-8306-2285e7e926c12021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 PorcelainOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASa93cb6c6-d7c2-43cc-a2e8-961f896a977e2021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 LatteOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS32d99955-1593-426b-958e-5dcf689192a32021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 TawnyOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS762deb57-754b-46a9-9907-de05e11da1782021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 AmberOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS3b5366e4-180a-4b98-9524-63601ae9d2702021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool VanillaOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS9a0ab557-e1f3-4c89-a9ae-0f81fbc5032e2021-11-04WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 CalicoOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS3e67abb5-84a4-4a78-9ea3-9fd57cbeb4822021-11-04WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool IvoryOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS477d79c1-f169-4d0e-a95d-f5e832855f0d2021-11-04WarningsExact identifier
application number: M020
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.1510cae2-9c8f-45ba-b088-67747af3d30c2021-07-15WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 TawnyOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS3f0480e4-b2c3-962c-e063-6294a90a4f232021-07-13WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool IvoryOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASaa708db4-ad90-49b7-a250-5698e4c7d3d62021-07-13WarningsExact 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