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 263 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 ZINC OXIDE, TITANIUM DIOXIDE Expanscience Laboratories d/b/a Mustela beec926c-35a5-1901-e053-2a95a90ad043 2024-12-02 Warnings Exact identifier application number: M020 MUSTELA MINERAL SUNSCREEN SPF 50 ZINC OXIDE Expanscience Laboratories d/b/a Mustela b850f68e-4f52-6902-e053-2995a90aaa91 2024-12-02 Warnings Exact identifier application number: M020 Hero Force Shield Superbeam Sunscreen SPF 30 Apricot ZINC OXIDE Church & Dwight Co., Inc. 133dc4db-6598-4400-8aa4-022f66eb28fc 2024-12-02 Warnings Exact identifier application number: M020 AHAVA MultiVitamin Day SPF30 AVOBENZONE, ENSULIZOLE, OCTISALATE, AND OCTOCRYLENE AHAVA - Dead Sea Laboratories Ltd d9b8e9ae-ed05-4e9c-8d01-8fac183053a4 2024-12-02 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Face Stick Unscented SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d8551c6-2efe-11a8-e063-6294a90aed01 2024-12-01 Warnings Exact identifier application number: M020 ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Face Stick Unscented SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d958343-31e3-0b7a-e063-6294a90a424a 2024-12-01 Warnings Exact identifier application number: M020 Attitude Kids mineral sunscreen unscented SPF 30 ZINC OXIDE 9055-7588 Qubec Inc. DBA Attitude c2461e22-1518-4f9e-ad8c-951784ef8b5f 2024-12-01 Warnings Exact identifier application number: M020 BIO SPECTRA ATTITUDE ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 954713fe-c84c-41b4-913d-3507ed91e55d 2024-12-01 Warnings Exact identifier application number: M020 CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Caudalie USA, Inc. 150e3bf3-7b05-e611-e063-6294a90a0932 2024-11-29 Warnings Exact identifier application number: M020 CLEARING DEFENSE SPF30 OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONE Dermalogica, LLC. 2cb559d3-dd79-4951-ad38-190fd4dd7c40 2024-11-27 Warnings Exact identifier application number: M020 Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank Moisturizer AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC 1ccde0bc-08aa-8a25-e063-6394a90a2762 2024-11-25 Warnings Exact identifier application number: M020 Girlyish Skincare Mineral Sunscreen SPF 30 ZINC OXIDE Rise Skincare LLC 137ba0be-91ce-4bd0-9713-57b169359750 2024-11-25 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 9N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 95d657e5-cf89-48dd-a12e-f9664b131eb9 2024-11-25 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 33f42840-92f8-4fa1-86e9-ec0a06d637de 2024-11-25 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 20785934-e534-4ea5-8c15-f9669b042153 2024-11-25 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior e4464601-a9ec-413b-a883-9efe61f2f5b2 2024-11-25 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 8N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5e7c879c-1e5c-4614-bec1-d363978c3b0d 2024-11-25 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5c1f1f09-19fb-4ceb-bb6d-22d51b5733a8 2024-11-25 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior c8a48759-efac-47ac-972a-c994b6774e20 2024-11-25 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 793c18e5-4363-45b0-a184-0b6c69a91b2c 2024-11-25 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