Home NDC 69555-040 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 69555-040 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69555-040 69555-040-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…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 Ingredient Strength ZINC OXIDE .2 g/80g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69555-040-01 4ocean REEF SAFE SUNSCREEN SPF 40 80 g in 1 JAR CREAM 80 4 69555-040-03 4ocean REEF SAFE SUNSCREEN SPF 40 80 g in 1 JAR CREAM 80 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69555-040 4OCEAN 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] 3 Current NDC, 2 package rows 20250519_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 223 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50 TITANIUM OXIDE, ZINC OXIDE NAKED SUNDAYS PTY LTD 0ce809a1-45fb-9d4d-e063-6294a90a26a2 2025-03-23 Warnings Exact identifier application number: M020 GLOW BODY MIST SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE NAKED SUNDAYS PTY LTD cba78484-3c0b-413e-e053-2995a90aad86 2025-03-23 Warnings Exact identifier application number: M020 ISNTREE HYALURONIC ACID NATURAL SUNCREAM ZINC OXIDE ISNTREE Inc. 2a86be75-c0f3-a8a1-e063-6294a90a0448 2025-03-23 Warnings Exact identifier application number: M020 SPF50 SHEER GLOW BALM ESPRESSO MARTINI 9g ZINC OXIDE 22.75% NAKED SUNDAY PTY LTD fbfc1e74-139e-8b0d-e053-6394a90a97c5 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays PoutScreen Plumping Lip Treatment Caramel Latte 10mL LIP TREATMENT NAKED SUNDAYS PTY LTD 2499e14a-c14f-ea13-e063-6394a90a62f5 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mL LIP TREATMENT NAKED SUNDAYS PTY LTD 24a7bee2-3802-4786-e063-6294a90a6ab5 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays PoutScreen Plumping Lip Treatment VANILLA CONFETTI 10mL LIP TREATMENT NAKED SUNDAYS PTY LTD 24aa19c8-86d9-c691-e063-6394a90a691e 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays PoutScreen Plumping Lip Treatment Marshmallow 10mL LIP TREATMENT NAKED SUNDAYS PTY LTD 24a98d3d-f830-9614-e063-6394a90aa7d1 2025-03-22 Warnings Exact identifier application number: M020 SPF50 SHEER GLOW BALM CHAMPAGNE 9g ZINC OXIDE 22.75% NAKED SUNDAY PTY LTD fbfb871b-460f-271a-e053-6394a90acad2 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Bronze 8g ZINC OXIDE NAKED SUNDAYS PTY LTD 2f42d22a-983e-d304-e063-6294a90a3719 2025-03-22 Warnings Exact identifier application number: M020 SPF50 SHEER GLOW BALM ROSE 9g ZINC OXIDE 22.75% NAKED SUNDAY PTY LTD fbfbd0dd-8961-5fd0-e053-6294a90a5de4 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays Face Body Clear Glow Sunstick SPF50 SHIMMER Broad Spectrum SPF50 19g AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5% ,OCTOCRYLENE 8% NAKED SUNDAYS PTY LTD 2f47a6c9-dd0a-da94-e063-6294a90a9a45 2025-03-22 Warnings Exact identifier application number: M020 Obagi Skintrinsiq Firming Protocol TITANIUM DIOXIDE AND ZINC OXIDE Obagi Cosmeceuticals LLC 67ba9f32-bbf4-4c14-9e97-08f1cb7d3996 2025-03-21 Warnings Exact identifier application number: M020 Obagi Skintrinsiq Brightening Protocol HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC 2f75ebf7-d6b6-45c6-ad5b-61739d260ff7 2025-03-21 Warnings Exact identifier application number: M020 Hello Kitty Fun Broad Spectrum SPF 40 ZINC OXIDE The Creme Shop Inc 30d37581-122c-ec92-e063-6294a90ab425 2025-03-21 Warnings Exact identifier application number: M020 Hello Kitty Sunny Days Broad Spectrum SPF 40 ZINC OXIDE The Creme Shop Inc 30d3ed8c-f424-8d95-e063-6394a90a0cbc 2025-03-21 Warnings Exact identifier application number: M020 Carmex Variety Pack Daily Care Moisturizing Lip Balm SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. c7142781-fa57-43e5-9436-cb29dd03a669 2025-03-21 Warnings Exact identifier application number: M020 SHISEIDO ULTIMATE SUN PROTECTOR AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE SHISEIDO AMERICAS CORPORATION 00ec7d9c-8550-45ce-8d0a-ef2caf84f98d 2025-03-21 Warnings Exact identifier application number: M020 Obagi Skintrinsiq Clarifiying Protocol SALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDE Obagi Cosmeceuticals LLC 08ba9ea8-73fd-472b-9cc4-67df167352ec 2025-03-21 Warnings Exact identifier application number: M020 Aveeno Kids Continuous Protection Sensitive Skin Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 3e51da46-6a81-4b74-b16e-3fc298a4ba59 2025-03-20 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69555-040-01 69555004001 80 g in 1 JAR (69555-040-01) 80 g 2023-03-27 No No Current 69555-040-03 69555004003 80 g in 1 JAR (69555-040-03) 80 g 2025-05-16 No No Current