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 38 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RE SCREEN BROAD SPECTRUM SPF 30 SUNSCREEN ZINC OXIDE Zouck LLC 507560fe-c7ad-329a-e063-6394a90a039a 2026-04-27 Warnings Exact identifier application number: M020 SoloVegan HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE YES SALES INC. 435748e6-c39a-efee-e063-6294a90ad0e5 2026-04-27 Warnings Exact identifier application number: M020 SCREEN SCREEN BROAD SPECTRUM SPF 30 SUNSCREEN ZINC OXIDE Zouck LLC 50764f40-7881-81a3-e063-6294a90ad1cf 2026-04-27 Warnings Exact identifier application number: M020 Obagi Skintrinsiq Antioxidant Protocol AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE Obagi Cosmeceuticals LLC 495bc176-b292-448f-a5a6-00de2e475e54 2026-04-27 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f45bd7bd-a802-33e4-e053-2a95a90a61a7 2026-04-23 Warnings Exact identifier application number: M020 TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER PML NYC, LLC 1c2e9b0d-ba0e-1767-e063-6394a90a756c 2026-04-23 Warnings Exact identifier application number: M020 Skincare LdeL Retinol Day Broad Spectrum SPF 20 AVOBENZONE, HOMOSALATE, OXYBENZONE, AND OCTINOXATE Beauty Solutions, Ltd. 76e2ed34-c643-402b-9c9d-04eac789d3c2 2026-04-22 Warnings Exact identifier application number: M020 Johnsons Baby Mineral Sunscreen SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC 4fe04c4b-2751-0561-e063-6394a90af768 2026-04-22 Warnings Exact identifier application number: M020 Johnsons Baby Mineral Sunscreen Stick SPF 50 ZINC OXIDE Kenvue Brands LLC 4fe1d3c6-7748-d966-e063-6394a90a97ff 2026-04-22 Warnings Exact identifier application number: M020 OVERLAPS ECTOIN MOIST SUN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Overlaps Corp. 4c3ed60b-e515-8ff0-e063-6294a90a86df 2026-04-22 Warnings Exact identifier application number: M020 Lazy Face SPF 30 Facescreen TITANIUM DIOXIDE, ZINC OXIDE Sunny Day Creations 500ee303-7302-68d5-e063-6394a90ac6d4 2026-04-22 Warnings Exact identifier application number: M020 Lazy Face SPF 30 Facestick ZINC OXIDE Sunny Day Creations 50101b55-793e-dbe4-e063-6394a90a6199 2026-04-22 Warnings Exact identifier application number: M020 Broad Spectrum Sunscreen SPF 30 OCTOCRYLENE 10% HOMOSALATE 10% OCTISALATE 5 % AVOBENZONE 3% S&C Hampton Sun LLC e6103de6-1d80-46fd-b9d4-893f60941def 2026-04-22 Warnings Exact identifier application number: M020 PhotoAge Guard AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE MACROMOTION, INC. 50164bd8-469d-9ec1-e063-6294a90a543d 2026-04-22 Warnings Exact identifier application number: M020 THANK YOU FARMER Sun Project Silky Calming Sun Stick AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE THANK YOU FARMER CO., LTD 49947114-5137-dc45-e063-6394a90ad9d0 2026-04-22 Warnings Exact identifier application number: M020 Sky and Sol Intense Healing Lip Jelly NON-NANO ZINC OXIDE Delta Ecommerce LLC 2ddaa215-7433-c8fa-e063-6394a90a4316 2026-04-22 Warnings Exact identifier application number: M020 Broad Spectrum SPF45 ZINC OXIDE, OCTINOXATE Drmtlgy, LLC 0445ee5f-45a8-4fd5-ae4d-62f66e6f0be8 2026-04-21 Warnings Exact identifier application number: M020 BLDG Active Skin Repair Face and Body Performance Sunscreen ZINC OXIDE Innovacyn, Inc. 70cb98cf-739b-4d46-b45a-535ff0a4531c 2026-04-21 Warnings Exact identifier application number: M020 Freaks of Nature Mineral Sunscreen ZINC OXIDE MINERAL SUNSCREEN Empack Spraytech Inc. 4ffdb1c6-b2c6-628f-e063-6394a90a2769 2026-04-21 Warnings Exact identifier application number: M020 THANK YOU FARMER Sun Project Water Sun Cream AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE THANK YOU FARMER CO., LTD 5004126b-0a9c-21fb-e063-6294a90a5237 2026-04-21 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