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 91 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMYZINC OXIDEKao USA Inc.26bcb9cd-bfb5-998c-e063-6394a90ab9d62026-01-05WarningsExact identifier
application number: M020
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUDZINC OXIDEKao USA Inc.26cf1320-aae5-2ea0-e063-6394a90a3be22026-01-05WarningsExact identifier
application number: M020
OZE SUN BONDIZINC OXIDE SUNSCREENVEGANIC SKN LIMITED47b1aae6-0b86-7d48-e063-6294a90a9ece2026-01-05WarningsExact identifier
application number: M020
Hybrid SPF SPF 30OCTOCRYLENE, OCTISALATE, ZINC OXIDETopiderm, Inc.5c99f98c-025c-4886-824f-af968033baf42026-01-05WarningsExact identifier
application number: M020
TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 PlusTITANIUM DIOXIDEHEY HONEY INC.21187805-fae9-476c-81b0-27ffeb0b99112026-01-05WarningsExact identifier
application number: M020
VEAKSON BEEF TALLOW SUNSCREENZINC OXIDE,PHENYLBENZIMIDAZOLE SULFONIC ACIDGuangdong Aimu Biological Technology Co., Ltd473c241a-1258-1680-e063-6394a90a7d982026-01-04WarningsExact identifier
application number: M020
HYDRATING SUNSCREENHYDRATING SUNSCREENGuangzhou Yapeng Refinement Chemical Co., Ltd.19a3687b-32b0-7c83-e063-6294a90aaf812026-01-04WarningsExact identifier
application number: M020
Bellas Friends Sunscreen StickZINC OXIDEPanergytek Usa Inc478cbdeb-28e4-fa56-e063-6294a90af1242026-01-04WarningsExact identifier
application number: M020
Bellas Friends Roll-on SunscreenTITANIUM DIOXIDE, ZINC OXIDEPANERGYTEK USA INC478d46ce-14e8-2231-e063-6394a90a3e272026-01-04WarningsExact identifier
application number: M020
Ava Isa Sun Lip Sun Whip Clear SunshineZINC OXIDECyberderm Laboratories inc.a8646ee4-5e6e-6cdd-e053-2a95a90aee772026-01-01WarningsExact identifier
application number: M020
Ava Isa Sun Lip Sun Whip Strawberry ZinniaZINC OXIDECyberderm Laboratories inc.a888396f-489f-7e7c-e053-2995a90aee5b2026-01-01WarningsExact identifier
application number: M020
Ava Isa Sun Lip Sun Whip Watermelon LilyZINC OXIDECyberderm Laboratories inc.a8889754-8e33-4d2a-e053-2995a90a60802026-01-01WarningsExact identifier
application number: M020
OKeeffes Lip RepairAVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENEThe Gorilla Glue Company/O'Keeffe's Company6805b3e9-77cb-bfee-e053-2991aa0a8d982026-01-01WarningsExact identifier
application number: M020
Walgreens 50 Pina Colada Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY4978c811-be34-9fc3-e063-6394a90a2d802026-01-01WarningsExact identifier
application number: M020
Unicorn Snot 35 SPF Glitter Spritz rose gold shimmerAVOBENZONE, OCTISALATE, OCTOCRYLENEJailbreak Toys, Inc. DBA UNICORN SNOT498b7c1a-e66d-9736-e063-6394a90a47122026-01-01WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Day Cream SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBCM Ltdf7d5aa8a-9f4a-426b-ac9d-9690cf0103e02026-01-01WarningsExact identifier
application number: M020
MAUI ISLAND SECRET BROWNING CREME Broad Spectrum Sunscreen SPF 5ZINC OXIDEFormula 7venz L.L.C.5f3cdec9-2cc2-4660-827f-d286883d907c2025-12-31WarningsExact identifier
application number: M020
SOLARA SUNCARE - GO VACATION GLOW SPF 30ZINC OXIDESOLARA SUNCARE, INC.1f5cb694-f065-7ebc-e063-6394a90a883a2025-12-31WarningsExact identifier
application number: M020
SUNSCREEN GLOWING, SPF 30SUNSCREEN GLOWING LOTIONFSA Store Inc473bcb90-ab7f-170b-e063-6294a90a99d52025-12-31WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC05ba5966-f0ff-5360-e063-6294a90a0fc92025-12-31WarningsExact 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