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 303 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Florida Squeezed SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Florida Squeezed 13696dc6-ae64-4760-e063-6394a90ac192 2024-03-11 Warnings Exact identifier application number: M020 BB Noir 30 BS SPF30 ZINC OXIDE AND TITANIUM DIOXIDE Allure Labs 136a7f66-844c-b16a-e063-6294a90aa975 2024-03-11 Warnings Exact identifier application number: M020 Brush On Block Sheer Genius SPF 50 Mineral Moisture Universal Tint ZINC OXIDE SPF Ventures, LLC 12d27da2-2689-496a-e063-6294a90aaa9f 2024-03-08 Warnings Exact identifier application number: M020 Avene Multi-Defense Fluid ZINC OXIDE Pierre Fabre USA Inc. 1329e56d-1e74-4bcc-e063-6394a90ae0c3 2024-03-08 Warnings Exact identifier application number: M020 Avene Multi-Defense Fluid Tinted ZINC OXIDE Pierre Fabre USA Inc. 132bdf9a-c5d0-e7e5-e063-6394a90a6180 2024-03-08 Warnings Exact identifier application number: M020 Avene Face Sunscreen SPF 50 ZINC OXIDE Pierre Fabre USA Inc. 132ce436-a783-2ba0-e063-6394a90a4b70 2024-03-08 Warnings Exact identifier application number: M020 TROPICAL OTTERS Glitter Sunscreen SPF-50 - Sugar Sparkle HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE 6174 INDUSTRIES, LLC cfd1e0c7-7e4c-41c1-8788-b73f83bf38c9 2024-03-06 Warnings Exact identifier application number: M020 TROPICAL OTTERS Glitter Sunscreen SPF-50 - Fragrance Free HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE 6174 INDUSTRIES, LLC 658b1b20-6540-4f3a-ac9a-170bc8fcba11 2024-03-06 Warnings Exact identifier application number: M020 Daily Facial Moisturizer SPF 15 EQB AVOBENZONE 3% OCTOCRYLENE 10% Walmart a0c452a9-3e99-41b8-b9b2-c1b57b66f183 2024-03-06 Warnings Exact identifier application number: M020 Target Up and Up Sport SPF 50 AVOBENZONE, HOMOSALAT, OCTISALATE, OCTOCRYLENE TARGET CORPORATION b81b2e7e-6d7f-fa1d-e053-2995a90a7d15 2024-03-06 Warnings Exact identifier application number: M020 Target Up and Up Reef Conscious Formula SPF 50 Sport Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE TARGET CORPORATION b5fd43ee-9fa1-13c1-e053-2995a90a364a 2024-03-06 Warnings Exact identifier application number: M020 Vacation SPF 30 Baby Oil AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Vacation Inc. f6030311-5287-3aa3-e053-2995a90a1b87 2024-03-06 Warnings Exact identifier application number: M020 Brush On Block Sun Shine SPF 30 Protective Lip Oil Nude Tint TITANIUM DIOXIDE/ZINC OXIDE SPF Ventures LLC 12e5493f-6478-0ff4-e063-6394a90af4f5 2024-03-05 Warnings Exact identifier application number: M020 Brush On Block Sun Shine SPF 30 Protective Lip Oil Coral TITANIUM DIOXIDE/ZINC OXIDE SPF Ventures LLC 12e65634-2e6d-b030-e063-6294a90ad1c4 2024-03-05 Warnings Exact identifier application number: M020 Brush On Block Sun Shine SPF 30 Protective Lip Oil Fig TITANIUM DIOXIDE/ZINC OXIDE SPF Ventures LLC 12e7507d-6612-fda4-e063-6294a90a1db7 2024-03-05 Warnings Exact identifier application number: M020 Dermachange SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Private Label Beauty and Wellness 12f00cee-dd9b-19b1-e063-6294a90adccb 2024-03-05 Warnings Exact identifier application number: M020 Brush On Block Quick Stick SPF 40 Mineral Stick ZINC OXIDE SPF Ventures LLC 12d10ec9-847a-7483-e063-6294a90a42a7 2024-03-04 Warnings Exact identifier application number: M020 Lucin Organics Tinted Sunscreen SPF 30 Non Nano Zinc Oxide ZINC OXIDE Lucin Organics, LLC d717dda8-60bb-40a0-86f9-6d724d695d16 2024-03-04 Warnings Exact identifier application number: M020 Brush On Block Bounce Butter SPF 30 Moisturizing Mousse ZINC OXIDE SPF Ventures LLC 12956754-b4e5-0203-e063-6294a90a2b96 2024-03-01 Warnings Exact identifier application number: M020 Derma E Sun Protection Mineral SPF 30 ZINC OXIDE derma e bb8e3df2-23e8-4ad0-a662-ff02d156e7b1 2024-02-26 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