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 195 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sun Bum 50 Premium Moisturizing Sunscreen Roll-On AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3c58c9c7-ca9e-d012-e063-6394a90a5aa9 2025-08-14 Warnings Exact identifier application number: M020 Sun Bum 30 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3a003d82-90bd-f541-e063-6394a90ac906 2025-08-14 Warnings Exact identifier application number: M020 Sun Bum 50 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3a00e4fb-6bf2-4c44-e063-6294a90a61bf 2025-08-14 Warnings Exact identifier application number: M020 Sun Bum 15 Premium Moisturizing Sunscreen 8 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3a0f99df-e6c0-71d9-e063-6294a90a4c9e 2025-08-14 Warnings Exact identifier application number: M020 Sun Bum 50 Mineral Sunscreen ZINC OXIDE Sun Bum, LLC 3a13d4f1-c158-7fa0-e063-6294a90a6fb4 2025-08-14 Warnings Exact identifier application number: M020 Sun Bum Kids 50 Clear Sunscreen Face Stick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3a147fe1-0dda-5433-e063-6394a90a1a59 2025-08-14 Warnings Exact identifier application number: M020 Sun Bum 15 Premium Sunscreen Browning AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3c5b0db8-f05a-2b5c-e063-6294a90ae79b 2025-08-14 Warnings Exact identifier application number: M020 Sun Bum 50 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3aaf7d28-b306-b416-e063-6294a90a021e 2025-08-14 Warnings Exact identifier application number: M020 Sun Bum 50 Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Sun Bum, LLC 3a263b85-e7a0-c068-e063-6294a90a49f2 2025-08-14 Warnings Exact identifier application number: M020 Sun Bum 50 Mineral Sunscreen Roll-On TITANIUM DIOXIDE, ZINC OXIDE Sun Bum, LLC 3a392237-019d-2384-e063-6394a90a5b24 2025-08-14 Warnings Exact identifier application number: M020 Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Bonfire HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE Sun Bum, LLC 3a3b3b4a-148c-1dc5-e063-6394a90a7bdb 2025-08-14 Warnings Exact identifier application number: M020 Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude Beach HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE Sun Bum, LLC 3ac48eef-f651-af96-e063-6294a90a501e 2025-08-14 Warnings Exact identifier application number: M020 Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Aruba Aloe Balm NV 6a398dad-2fb9-4cdb-86c5-2a392b88f29b 2025-08-13 Warnings Exact identifier application number: M020 SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40 ZINC OXIDE ALL THE RAJE, LLC 9ffbd53b-1295-42b4-9cd5-18cbb75921d0 2025-08-13 Warnings Exact identifier application number: M020 MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 02 Umber, Bistre ZINC OXIDE Power Beauty Co. 2e6eac42-0b70-44ea-e063-6294a90a49f8 2025-08-13 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE/OCTOCRYLENE/OXYBENZONE Edgewell Personal Care Brands LLC 3c414e9b-6c3e-2c8d-e063-6394a90af4a6 2025-08-13 Warnings Exact identifier application number: M020 Earth Mama Baby Mineral Sunscreen SPF 40 ZINC OXIDE Eleeo Brands LLC 3c443347-0134-8c87-e063-6294a90a8046 2025-08-13 Warnings Exact identifier application number: M020 Earth Mama Baby Face Mineral Sunscreen Stick SPF 40 ZINC OXIDE Eleeo Brands LLC 3a22f0b9-2d6d-6230-e063-6294a90adf31 2025-08-13 Warnings Exact identifier application number: M020 Earth Mama Lady Face Tinted Mineral Sunscreen Stick SPF 40 ZINC OXIDE Eleeo Brands LLC 3c4567d6-879e-f995-e063-6394a90a319f 2025-08-13 Warnings Exact identifier application number: M020 Silk Screen TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c457455-b9b1-546b-e063-6294a90a41f6 2025-08-13 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