Home NDC 84616-005 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM
Product NDC 84616-005
11-digit product format 846160005
Labeler code 84616
Product ID 84616-005_4260e398-1153-07e9-e063-6394a90ac3be
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate
Dosage form CREAM
Route TOPICAL
Labeler SEORIN COMPANY Co., Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-18
Substance HOMOSALATE; OCTISALATE; AVOBENZONE
Active strength 13.5; 4.5; 2.7 g/100mL; g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 84616-005-03 excluded package package 84616-005-01 excluded package package 84616-005-02
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 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 13.5 g/100mL OCTISALATE 4.5 g/100mL AVOBENZONE 2.7 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V06SV4M95S Internal UNII lookup 4X49Y0596W Internal UNII lookup G63QQF2NOX 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 84616-005-01 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM 50 mL in 1 TUBE CREAM 50 1 84616-005-02 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM 10 mL in 1 TUBE CREAM 10 1 84616-005-03 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM 2 in 1 BOX CREAM 2 1 84616-005-04 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM 60 mL in 1 TUBE CREAM 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84616-005 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SEORIN COMPANY CO., LTD.] 3 Current NDC 20250418_228dcd68-aaba-0451-e063-6394a90a8ad0.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 214 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lip Love Moisture Balm SPF30 - Watermelon ZINC OXIDE Koco Life LLC 3491fb2a-d55f-1736-e063-6294a90a594a 2025-05-07 Warnings Exact identifier application number: M020 Abib Heartleaf mild sunscreen Relief tube ZINC OXIDE FOURCOMPANY CO., LTD. 34965587-c9b7-4066-e063-6394a90ab424 2025-05-07 Warnings Exact identifier application number: M020 CLARINS - MULTI-INTENSIVE JOUR SUPER RESTORATIVE DAY BROAD SPECTRUM - SPF 15 - SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Laboratoires Clarins 157cb8ca-1a36-41fb-be9e-b157b146dc4d 2025-05-06 Warnings Exact identifier application number: M020 Mango Bay SPF 50 Sport AVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENE Inspec Solutions e25e4f76-8311-491b-e053-2a95a90a4fc8 2025-05-06 Warnings Exact identifier application number: M020 Mango Bay SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Inspec Solutions LLC. e260b901-5918-48df-e053-2a95a90a68c3 2025-05-06 Warnings Exact identifier application number: M020 Mango Bay SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Inspec Solutions LLC. e25cf8e4-93cd-f5f6-e053-2995a90a4545 2025-05-06 Warnings Exact identifier application number: M020 Mango Bay SPF 30 Gallon AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Inspec Solutions LLC. e260c1bc-8b79-abc7-e053-2a95a90ae4d2 2025-05-06 Warnings Exact identifier application number: M020 Lip Love Moisture Balm SPF30 - Pink Strawberry ZINC OXIDE Koco Life LLC 347e665f-cb59-ab04-e063-6394a90ad0a6 2025-05-06 Warnings Exact identifier application number: M020 Saucd Toasted Golden Tanning SPF 15 Caramel AVOBENZONE, OCTISALATE, HOMOSALATE SAUCD GENERAL TRADING COMPANY e10d41cd-e03e-401c-9024-263350b3ec2a 2025-05-05 Warnings Exact identifier application number: M020 Visor Clear Body Mist Hydrating Sunscreen SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE VISOR SKINCARE LLC b2d7639c-cbfb-4127-8ee4-7355e0d021e1 2025-05-05 Warnings Exact identifier application number: M020 Jacket Ultimate Performance Sunscreen SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE BALSHI MD DERMACEUTICALS d4d82c41-01da-40af-a22c-d4d57af7a2f2 2025-05-05 Warnings Exact identifier application number: M020 All Good Mineral Sport Sunscreen Butter Stick SPF 50 ZINC OXIDE Elemental Herbs, Inc. 114c6ac8-b133-cd16-e063-6294a90ac4f9 2025-05-05 Warnings Exact identifier application number: M020 All Good kids mineral sunscreen butter stick SPF 50 ZINC OXIDE Elemental Herbs, Inc. feb94fd7-6727-6fb1-e053-6394a90a2af1 2025-05-05 Warnings Exact identifier application number: M020 Vivier Sheer SPF 30 Mineral Tinted TITANIUM DIOXIDE, ZINC OXIDE Vivier Pharma, Inc. e12e3bcb-4c3d-41be-8e2b-12a817c8b367 2025-05-05 Warnings Exact identifier application number: M020 EVERY DAY MINERAL SUN SCREEN SPF 45 ZINC OXIDE Stream2Sea, LLC 7ec4954f-7d60-405b-8bff-cb602fc44a4e 2025-05-04 Warnings Exact identifier application number: M020 ABIB QUICK AND AIRY SUNSTICK DUO SET HOMOSALATE, OCTOCRYLENE,OCTISALATE,AVOBENZONE FOURCOMPANY CO., LTD. 34292261-4d05-e07d-e063-6294a90a4741 2025-05-02 Warnings Exact identifier application number: M020 LION POSE UNGHOSTED TINTED MINERAL SPF 42 UVA UVB SUNSCREEN ZINC OXIDE Lion Pose Inc. 341b90b4-82ae-e8c6-e063-6394a90aeefd 2025-05-01 Warnings Exact identifier application number: M020 LAPCOS DAILY SUNSCREEN SPF 50 SUNSCREEN LAP USA, INC. 337c3528-5739-6b4a-e063-6294a90a3cb4 2025-05-01 Warnings Exact identifier application number: M020 Hiya Kids SPF 40 Mineral Sunscren ZINC OXIDE Hiya Health Products LLC 33119ec6-2cd8-8978-e063-6394a90afd97 2025-05-01 Warnings Exact identifier application number: M020 EltaMD UV AOX Elements ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN CP Skin Health Group, Inc d01756c0-1f82-4e08-b956-8000ecaddfd1 2025-05-01 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 84616-005-01 84616000501 50 mL in 1 TUBE (84616-005-01) 50 ml 2024-09-18 No No Current 84616-005-02 84616000502 10 mL in 1 TUBE (84616-005-02) 10 ml 2024-12-18 No No Current 84616-005-03 84616000503 2 TUBE in 1 BOX (84616-005-03) / 60 mL in 1 TUBE (84616-005-04) 2 tube 2024-12-20 No No Current 84616-005-04 84616000504 60 mL in 1 TUBE 60 ml Historical