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 301 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carmex Daily Care Moisturizing Lip Balm SPF 15 Assorted HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Carma Laboratories, Inc. 22821e9d-eb3a-4e21-87ae-737b25125534 2024-04-03 Warnings Exact identifier application number: M020 Meadow and Bark SPF 45 Mineral Shimmer Sunscreen ZINC OXIDE Meadow and Bark 14bbd191-ef3b-628e-e063-6294a90a1e66 2024-04-03 Warnings Exact identifier application number: M020 Meadow and Bark SPF 45 Mineral Sport Sunscreen ZINC OXIDE Meadow and Bark 1494c0e1-97f5-411c-e063-6294a90ab2ca 2024-04-03 Warnings Exact identifier application number: M020 LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-F OCTINOXATE, ZINC OXIDE BEL STAR S A ea3a0e07-a277-48c8-e053-2a95a90a172f 2024-04-02 Warnings Exact identifier application number: M020 Rio Radiance SPF 50 BodySpray OCTOCRYLENE, OCTISALATE, AVOBENZONE Sol de Janeiro USA, Inc 1520a151-70c4-8699-e063-6294a90adc6b 2024-04-02 Warnings Exact identifier application number: M020 Meijer SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Meijer 075efd92-1632-d8c8-e063-6294a90a8c1a 2024-04-02 Warnings Exact identifier application number: M020 Good Molecules Sheer Mineral Sunscreen SPF 30 ZINC OXIDE Good Molecules, LLC e9596344-a7ab-f582-e053-2a95a90a5525 2024-04-02 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum Minis HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Carma Laboratories, Inc. f5c4186e-f167-40fc-b308-0b4406d3ec55 2024-04-02 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum Minis Holiday AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Carma Laboratories, Inc. 95d9a485-7418-437a-8e7d-ebcc09088356 2024-04-02 Warnings Exact identifier application number: M020 Rejuvenating Priming Moisturizer BS Sunscreen SPF30 ZINC OXIDE Allure Labs 14cff1a3-89b9-f4da-e063-6394a90a1a41 2024-03-29 Warnings Exact identifier application number: M020 Lemongrass Spa Products SPF 45 Tinted Mineral Sunscreen ZINC OXIDE Lemongrass Spa Products, LLC 14bcbaf9-76a5-f8ba-e063-6294a90a91f6 2024-03-28 Warnings Exact identifier application number: M020 Rubber Ducky SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Carefree Skincare Ventures, LLC 14bd5cf9-423e-53a8-e063-6394a90a29f1 2024-03-28 Warnings Exact identifier application number: M020 RV Illuminance Serum Tint Broad Spectrum 15 FACE FOUNDATION WITH SPF REVLON CONSUMER PR Consumer Products Corp 132aab60-da19-7079-e063-6394a90a1d76 2024-03-27 Warnings Exact identifier application number: M020 NAELI TINT Tinted Mineral Moisturizer SPF 50 ZINC OXIDE ALLI LLC 25a88843-078b-4589-b8b7-ea439ba6a15b 2024-03-27 Warnings Exact identifier application number: M020 Rio Radiance SPF 50 BodyLotion ZINC OXIDE SOL DE JANEIRO USA, INC. 14a85a88-c9a2-94ea-e063-6394a90a4e14 2024-03-27 Warnings Exact identifier application number: M020 Rio Radiance SPF 50 Body Oil OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE SOL DE JANEIRO USA, INC. 14acf152-e72a-debb-e063-6294a90a243d 2024-03-27 Warnings Exact identifier application number: M020 RV Illuminance Serum Tint Broad Spectrum 15 Amber FACE FOUNDATION WITH SPF REVLON CONSUMER PR Consumer Products Corp 2a0ac71c-e53a-5ff9-e063-6394a90a4807 2024-03-27 Warnings Exact identifier application number: M020 EltaMD UV Pure SPF47 ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN CP Skin Health Group, Inc. 9afe900b-4186-4189-a871-ad6f26fc26e4 2024-03-27 Warnings Exact identifier application number: M020 Eminence Daily Defense Tinted SPF ZINC OXIDE Eminence Organic Skin Care 14854bad-317e-154d-e063-6294a90a884f 2024-03-25 Warnings Exact identifier application number: M020 SPF 50 Mineral Based Facial Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hutton, Kathleen MD 5cf0d2e3-d496-424c-ac75-70ff5b87e9ca 2024-03-25 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