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 180 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Ivory ZINC OXIDE Cosmetic Enterprises Ltd 2748c351-0a7d-6913-e063-6394a90a6ef2 2025-10-13 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Nude ZINC OXIDE Cosmetic Enterprises Ltd 265bd73f-2509-90c6-e063-6294a90a2e19 2025-10-13 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC dad4b244-2d34-40cb-88dc-991358df83b0 2025-10-10 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Kids Sunscreen SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC eafc00ce-12e7-921f-e053-2995a90a241a 2025-10-10 Warnings Exact identifier application number: M020 Kinesys OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE Wilc Healthcare Inc 50adf1db-118f-4843-b356-e23993160673 2025-10-10 Warnings Exact identifier application number: M020 Kinesys Broad Spectrum SPF 30 Alcohol-Free Performance Sunscreen - Fragrance Free OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE Wilc Healthcare Inc e0949325-7de1-4da4-82b6-8004916412a0 2025-10-10 Warnings Exact identifier application number: M020 Meijer SPF 50 Sunscreen Mango AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Meijer 40d0294b-e937-336d-e063-6294a90a5c3c 2025-10-10 Warnings Exact identifier application number: M020 Kinesys Broad Spectrum SPF 30 Kids Alcohol-Free Sunscreen OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE Wilc Healthcare Inc 9adea1a4-efa6-4fe1-85e8-ed69fa098a87 2025-10-10 Warnings Exact identifier application number: M020 Kinesys Broad Spectrum SPF 30 Alcohol-Free Sunscreen - Mango Scent OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE Wilc Healthcare Inc 60e7ed8e-f421-4e08-97a8-af647200e4ae 2025-10-10 Warnings Exact identifier application number: M020 KINeSYS Pro Sport Lip Balm with Shea Butter Broad Spectrum 30 ZINC OXIDE Wilc Healthcare Inc e5820376-897f-4c77-aadc-7991137870b7 2025-10-10 Warnings Exact identifier application number: M020 KINeSYS Pro Sport Clear Mineral Sunscreen Stick Broad Spectrum SPF45 ZINC OXIDE Wilc Healthcare Inc 247a323f-9a08-4717-8553-ebc9c519817b 2025-10-10 Warnings Exact identifier application number: M020 Vertra S Dorian Kona Gold Signature Face Stick SPF 38 TITANIUM DIOXIDE Eai-jr 286, Inc b6c316c3-661b-6428-e053-2a95a90a1a6b 2025-10-10 Warnings Exact identifier application number: M020 Meijer SPF 50 Sunscreen Coconut AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Meijer 40d15366-85b8-f5e8-e063-6294a90a5fd8 2025-10-10 Warnings Exact identifier application number: M020 Premium Moisturizing Sunscreen Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f4369f2f-fdc3-e48e-e053-2995a90a07f7 2025-10-10 Warnings Exact identifier application number: M020 Sun Bum Face 50 Premium Sunscreen SPF 50 AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f4ac746a-a50a-8041-e053-2a95a90a8ea6 2025-10-10 Warnings Exact identifier application number: M020 Wonderscreen Broad Spectrum SPF 30 ZINC OXIDE Wasatch Product Development, LLC. e895d942-e50e-1ad6-e053-2995a90a0e02 2025-10-10 Warnings Exact identifier application number: M020 Illuminating SPF 50 plus drops Broad Spectrum Sunscreen ZINC OXIDE Cosmetic Enterprise Ltd 13f40485-b98e-e804-e063-6394a90af2af 2025-10-10 Warnings Exact identifier application number: M020 Impeccable Skin Moisturizing Face Sunscreen Broad Spectrum SPF 30 ZINC OXIDE Cosmetic Enterprises LTD a84d246b-1153-85ff-e053-2995a90a270a 2025-10-10 Warnings Exact identifier application number: M020 MediChoice Moisturizing Lip Balm SPF15 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE O&M HALYARD, INC. 00327815-28f0-4198-bca7-c8ae768ff416 2025-10-09 Warnings Exact identifier application number: M020 Daybird 4-in-1 Skin Tint Serum ZINC OXIDE Resette, Inc. 19c1a934-b0f5-1068-e063-6294a90a3b1f 2025-10-09 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