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 142 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mineral Sunscreen Dry Touch NT TITANIUM DIOXIDE, ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 334ffc49-3196-0995-e063-6394a90ad559 2025-12-09 Exact identifier application number: M020 Foam Weightless Sunscreen Non-Tinted Drytouch NT TITANIUM DIOXIDE, ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 335ec22c-6a9a-c4d1-e063-6394a90ac0b0 2025-12-09 Exact identifier application number: M020 Mineral Sunscreen Moisturizing Non-Tinted ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 3360a208-5f17-a74b-e063-6294a90a13e1 2025-12-09 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 323356ea-31a0-6ff0-e063-6294a90a135c 2025-12-09 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 32330376-5db0-202b-e063-6294a90add15 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Untinted ZINC OXIDE Lily Lee, MD 32354468-94a2-604b-e063-6394a90adfb5 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Tinted ZINC OXIDE Lily Lee, MD 32346536-f542-ef0f-e063-6394a90a0464 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Mineral Stick Untinted TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 3234b498-5b56-55f4-e063-6294a90a9b87 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Tinted ZINC OXIDE Lily Lee, MD 3235a696-92aa-788c-e063-6394a90a0149 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Mineral Stick Tinted TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 32351db0-884c-8fa0-e063-6294a90acba2 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Untinted ZINC OXIDE Lily Lee, MD 3235786d-7ba9-c9ab-e063-6294a90a7f2e 2025-12-09 Exact identifier application number: M020 Tinted Mineral Sunscreen 20% Zinc Oxide ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 31416d04-2d6f-7cf9-e063-6294a90a9806 2025-12-09 Warnings Exact identifier application number: M020 Matte Invisible Mineral Sunscreen Non-Tinted ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 3143968a-096e-b9ac-e063-6294a90ada0d 2025-12-09 Warnings Exact identifier application number: M020 Daily Mineral Sunscreen 20% Zinc Oxide ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 314299b1-a78b-c1bd-e063-6294a90ab43b 2025-12-09 Warnings Exact identifier application number: M020 Sheer Satin Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 3143d8b0-4af8-f52d-e063-6294a90a926b 2025-12-09 Warnings Exact identifier application number: M020 Matte Invisible Mineral Sunscreen ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 3142ed0f-f379-f240-e063-6294a90a5303 2025-12-09 Warnings Exact identifier application number: M020 Sheer Non-Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Face Collection, L.L.C. 33d83cfb-045d-141c-e063-6394a90a2e04 2025-12-09 Exact identifier application number: M020 First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 45875865-5e9c-d652-e063-6394a90ad5fa 2025-12-09 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Maloney Plastic Surgery Skin Care, PLLC 316b7584-c782-fe9e-e063-6394a90a76fe 2025-12-09 Exact identifier application number: M020 Transparent Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Face Collection, L.L.C. 33dbfd9b-b90f-bb32-e063-6294a90af7dc 2025-12-09 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