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 31 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SunPlus Healthy Skin Sunny Living SPF 30 Mist Sunscreen AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNPLUS SKIN CARE LLC 9b168046-3536-4ba9-9b5f-4f8c50b8b354 2026-05-14 Warnings Exact identifier application number: M020 SunPlus Healthy Skin Sunny Living SPF 50 Mist Sunscreen AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNPLUS SKIN CARE LLC 0e60ecee-d9f4-47e0-92f7-ff319e4422dd 2026-05-14 Warnings Exact identifier application number: M020 Hampton Sun SPF 15 Sunscreen OCTOCRYLENE 7.50% AVOBENZONE 2.50% OCTISALATE 5.00% S&C Hampton Sun LLC 3ce75e74-b5d3-4fbe-8d44-9b6f14f354df 2026-05-14 Warnings Exact identifier application number: M020 Target Up and Up SPF 30 Deep Repair Facial Moisturizer Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TARGET CORPORATION 51c9bdee-dcff-2818-e063-6294a90abb47 2026-05-14 Warnings Exact identifier application number: M020 Hampton Sun SPF 50 Baby Mineral ZINC OXIDE 20% S&C Hampton Sun LLC 42037d8c-4787-4e16-93fe-0d19b6b888fd 2026-05-14 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkle AVOBENZONE, OCTISALATE AND OCTOCRYLENE SICOS ET CIE 29c9d1cb-e249-47fa-a46d-42190e59d352 2026-05-14 Warnings Exact identifier application number: M020 Hampton SPF 15 UV-Advanced Sunscreen HOMOSALATE 7.50% OCTISALATE 5.00% AVOBENZONE 3.00% S&C Hampton Sun LLC 1659a681-6cf8-45ba-b1f8-e330eee3b9d4 2026-05-14 Warnings Exact identifier application number: M020 Easy Everything Sunscreen ZINC OXIDE VLT Ventures LLC 51cd48cf-38ae-f347-e063-6294a90a8a90 2026-05-14 Warnings Exact identifier application number: M020 Hampton Sun SPF 4 OCTOCRYLENE 4.00% AVOBENZONE 2.00% S&C Hampton Sun LLC 68763abc-0d6b-441c-9a99-cf3dc86e6deb 2026-05-14 Warnings Exact identifier application number: M020 Easy Everything Sunscreen ZINC OXIDE VLT Ventures LLC 51cdbac3-7f44-d72d-e063-6294a90a2f99 2026-05-14 Warnings Exact identifier application number: M020 Round Lab x OUWR Birch Juice Moisturizing UVLOCK Gift Set AVOBENZONE, HOMOSALATE, OCTISALATE SEORIN COMPANY Co., Ltd. 4feb1010-469f-7e6e-e063-6394a90a9a9e 2026-05-14 Warnings Exact identifier application number: M020 Round Lab Summer Travel Kit AVOBENZONE, HOMOSALATE, OCTISALATE SEORIN COMPANY Co., Ltd. 4f8722e2-4636-e8ba-e063-6294a90a91e4 2026-05-14 Warnings Exact identifier application number: M020 La Roche Posay Anthelios UV Air Serum Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc f3d841aa-b4fe-4a9d-8ad2-edd4445852d2 2026-05-14 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkle AVOBENZONE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc b746c24d-f775-4433-8519-49c3ec48ea0c 2026-05-14 Warnings Exact identifier application number: M020 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50 DIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE LOreal USA Products Inc 92a1d6ce-aff3-45fc-8d98-20c4375aded8 2026-05-14 Warnings Exact identifier application number: M020 MELAO TALLOW SUNSCREEN ETHYLHEXYL METHOXYCINNAMATA,ETHYLHEXYL SALICYATE Guangzhou Haishi Biological Technology Co., Ltd. 519d9f52-b704-d6cd-e063-6294a90a6e42 2026-05-13 Warnings Exact identifier application number: M020 Hampton Sun SPF30 Mineral ZINX OXIDE S&C Hampton Sun LLC 019b0c1a-f9f3-4756-8b24-35bf4dc4aa22 2026-05-13 Warnings Exact identifier application number: M020 Standard Procedure SPF 50 Sunscreen Face and Body AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Baxter Laboratories 34f6150d-9627-94a5-e063-6394a90ad448 2026-05-13 Warnings Exact identifier application number: M020 CeraVe Developed with Dermotologists Ultra Light Moisturizing Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc defa9588-95be-4f5c-86bb-53d6a1df7f5f 2026-05-13 Warnings Exact identifier application number: M020 MELAO TALLOW SUNSCREEN ETHYLHEXYL METHOXYCINNAMATE Guangzhou Haishi Biological Technology Co., Ltd. 22982b28-37df-ed81-e063-6394a90a77db 2026-05-12 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