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 254 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MILK TINT SPF 43 TINTED PRIMER SERUM MEDIUM ZINC OXIDE COSMAX USA, CORPORATION 298707d4-72ed-796f-e063-6294a90aa5cd 2024-12-18 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM LIGHT ZINC OXIDE COSMAX USA, CORPORATION 29871c02-9adf-6266-e063-6394a90a20ab 2024-12-18 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM TAN ZINC OXIDE COSMAX USA, CORPORATION 29874029-24bf-b2ce-e063-6394a90acd4d 2024-12-18 Warnings Exact identifier application number: M020 Babo Botanicals Sheer Zinc Mineral Sunscreen SPF 30 ZINC OXIDE Babo Botanicals, Inc. 2990e4ff-5bdb-3008-e063-6294a90a9497 2024-12-18 Warnings Exact identifier application number: M020 Tinted Lip Cream SPF 15 ZINC OXIDE COSMAX USA, CORPORATION 29915354-4673-7444-e063-6294a90a0fd1 2024-12-18 Warnings Exact identifier application number: M020 Mineral Lip Balm SPF-15 ZINC OXIDE TUBBY TODD 4d938672-5302-4e47-a582-c3e6467008cb 2024-12-18 Warnings Exact identifier application number: M020 SaltyFace Daily Sun Shield Mineral Sunscreen For Face SPF 30 ZINC OXIDE Saltyface Natural Inc f0cc7ce9-81b3-439f-b5ee-96138de54e78 2024-12-18 Warnings Exact identifier application number: M020 Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50 Jasmine TITANIUM DIOXIDE, ZINC OXIDE EK Clothing LLC dba Belasol e999d752-6c00-459e-b6c3-d264c330597d 2024-12-18 Warnings Exact identifier application number: M020 Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50 TITANIUM DIOXIDE, ZINC OXIDE EK Clothing LLC dba Belasol f22626c1-0996-41d8-a2ec-3bf7491df657 2024-12-18 Warnings Exact identifier application number: M020 Costa Sea Mineral Sunscreen SPF 50 ZINC OXIDE COSTA SEA INC 841e1b3d-dbbc-4bb0-886a-fb2d077ae739 2024-12-18 Warnings Exact identifier application number: M020 SPF 50 plus Sunscreen All Mineral Active Ingredients TITANIUM DIOXIDE AND ZINC OXIDE KAS Direct LLC dba BabyGanics 247aae3d-1845-4dd8-b774-b9e8214809a2 2024-12-18 Warnings Exact identifier application number: M020 Softlips Vanilla, Watermelon, Cherry DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE The Mentholatum Company 2235d029-157e-4a30-be90-605e6bc143fd 2024-12-17 Warnings Exact identifier application number: M020 Softlips Salted Caramel, Candy Apple, Marshmallow Ghost DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE The Mentholatum Company 42cf4623-0eb8-455a-b374-8e17e9336b92 2024-12-17 Warnings Exact identifier application number: M020 Softlips Peppermint Mocha, Apple Chai Cider, Orange Cranberry DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE The Mentholatum Company 0338c078-695d-4d4e-9e90-5a8a98d49524 2024-12-17 Warnings Exact identifier application number: M020 Softlips Pearl Plus Vanilla DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE The Mentholatum Company 107bcaa9-4347-4979-be44-35183a9ee67e 2024-12-17 Warnings Exact identifier application number: M020 Softlips Raspberry DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE The Mentholatum Company d18b4c19-0365-44ec-bea8-4328e537e0d8 2024-12-17 Warnings Exact identifier application number: M020 Softlips Watermelon DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE The Mentholatum Company 03062f13-270d-49cf-8939-2349f12e9cba 2024-12-17 Warnings Exact identifier application number: M020 Softlips Vanilla Watermelon DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE The Mentholatum Company f733747a-ad1a-4222-baf1-69dcd90a3350 2024-12-17 Warnings Exact identifier application number: M020 Softlips Vanilla Watermelon DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE The Mentholatum Company 1fbe85a2-4cd7-45bd-85a2-83bbf75c5f97 2024-12-17 Warnings Exact identifier application number: M020 Softlips Marshmallow Ghost DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE The Mentholatum Company 8d55141d-5d6f-4eec-87dc-d3c808cf7a6a 2024-12-17 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