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 279 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Kroger Dry Oil Tanning Sunscreen Broad Spectrum SPF 15 Reef Friendly AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE THE KROGER COMPANY c706aaf0-a978-7848-e053-2995a90a0aca 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE TOPCO ASSOCIATES LLC c51029f4-ede0-08ef-e053-2995a90aecaf 2024-10-15 Warnings Exact identifier application number: M020 TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, TOPCO ASSOCIATES LLC c8af028e-9d68-4023-e053-2995a90ad18a 2024-10-15 Warnings Exact identifier application number: M020 TOPCARE EVERYDAY ULTRA PROTECTION SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC c5601d22-2353-7319-e053-2a95a90a16c0 2024-10-15 Warnings Exact identifier application number: M020 TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC c8c12a5a-59f5-6515-e053-2995a90a58f7 2024-10-15 Warnings Exact identifier application number: M020 Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC c6268778-8dcc-24b6-e053-2995a90acf03 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Sport Sun SPF 50 AVOBENZONE, HOMOSALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC f0de2999-f12b-89b1-e053-2a95a90ac610 2024-10-15 Warnings Exact identifier application number: M020 TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 50 ZINC OXIDE TOPCO ASSOCIATES LLC d501a94e-3bcd-d8e4-e053-2a95a90a33b0 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Kids Mineral Sunscreen ZINC OXIDE TOPCO ASSOCIATES LLC dbee42c8-9cae-7a81-e053-2a95a90a2329 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Sport Sun Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC f12c09b1-8ffe-4933-e053-2995a90a434f 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Mineral Sunscreen Zinc Oxide SPF 30 ZINC OXIDE TOPCO ASSOCIATES LLC dbf03882-ab1a-9805-e053-2995a90a7109 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious Formula TITANIUM DIOXIDE, ZINC OXIDE TOPCO ASSOCIATES LLC f14f43e6-ee57-5495-e053-2a95a90a4011 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Sport Continuous Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE TOPCO ASSOCIATES LLC f31ea60e-1f52-c55f-e053-2a95a90afe64 2024-10-15 Warnings Exact identifier application number: M020 Topco Topcare Everyday Mineral Sunscreen Continuous SPF 30 ZINC OXIDE TOPCO ASSOCIATES LLC f71e019b-392a-f8eb-e053-6394a90a871e 2024-10-15 Warnings Exact identifier application number: M020 TOPCARE EVERYDAY SPORT SPF 70 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE TOPCO ASSOCIATES LLC a5b06600-f2b0-6d9b-e053-2995a90a59f0 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Ultra Protection Sun SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC f41d4c46-7998-afe6-e053-2995a90ab361 2024-10-15 Warnings Exact identifier application number: M020 TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50 OCTISALATE, ZINC OXIDE TOPCO ASSOCIATES LLC f71c9060-3daf-e1be-e053-6294a90a4f91 2024-10-15 Warnings Exact identifier application number: M020 MINERAL SUNSCREEN SPF 50 ZINC OXIDE, TITANIUM DIOXIDE TOPCO ASSOCIATES LLC bfe076fa-f21f-2c46-e053-2a95a90acee4 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 Mineral Sunscreen Stick ZINC OXIDE H.E.B. f58f0199-bf22-2197-e053-2995a90ae64f 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry Scented ZINC OXIDE H.E.B. f58d328c-8b30-b4d4-e053-2a95a90adb59 2024-10-15 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