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 193 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Olay Total Effects Moisturizer Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE The Procter & Gamble Manufacturing Company 8de52cb2-b4d2-1e0d-e053-2995a90a5aca 2025-08-19 Warnings Exact identifier application number: M020 Sun Bum 30 Mineral Sunscreen Lip Balm ZINC OXIDE Sun Bum, LLC 3cbfba65-5702-50b5-e063-6394a90a409d 2025-08-19 Warnings Exact identifier application number: M020 Sun Bum Signature High Performance Mineral Sunscreen Face Stick Tinted 50 ZINC OXIDE Sun Bum, LLC 324e8ddb-89d2-08ca-e063-6294a90ab6c1 2025-08-19 Warnings Exact identifier application number: M020 Sun Bum 70 Premium Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b02811d-dc66-fc6f-e063-6294a90aefc8 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Kids 50 Clear Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b058b74-27d0-8f8a-e063-6294a90aa02c 2025-08-18 Warnings Exact identifier application number: M020 PLAY Mineral Stick SPF 50 with Olive Fruit Extract ZINC OXIDE Supergoop LLC 3ca7e1ed-7cc7-76b0-e063-6394a90ade93 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Mineral 30 Sunscreen 6 OZ ZINC OXIDE Sun Bum, LLC 3b91a7e3-ce52-6aa0-e063-6394a90a15e7 2025-08-18 Warnings Exact identifier application number: M020 CoTZ Kids ZINC OXIDE Fallien Cosmeceuticals, LTD. 3ca8742f-67cb-a25c-e063-6394a90a4638 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum 30 Premium Moisturizing Sunscreen 8 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b154009-9c6f-eadf-e063-6394a90ae424 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Kids 50 Clear Sunscreen 6 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b162348-0222-490e-e063-6394a90ad494 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum 50 Premium Moisturizing Sunscreen 1.75 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b169860-66bc-dd02-e063-6294a90a7974 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum 30 Mineral Sunscreen Face 1.7 OZ TITANIUM DIOXIDE, ZINC OXIDE Sun Bum, LLC 3b1729c5-d8ca-94c7-e063-6394a90a67a5 2025-08-18 Warnings Exact identifier application number: M020 CoTZ Kids ZINC OXIDE Fallien Cosmeceuticals, LTD. 3ca914e2-cd53-42bf-e063-6294a90a7082 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Daily Mineral Sunscreen Moisturizer Broad Spectrum SPF 30 ZINC OXIDE Sun Bum, LLC 3b1a0596-b852-16be-e063-6394a90a3498 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Signature Clear High Performance Sunscreen Broad Spectrum SPF 50 1.5 OZ OCTISALATE, OCTOCRYLENE, ZINC OXIDE Sun Bum, LLC 3b29dbfc-0b92-eb0f-e063-6294a90a16e1 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum 30 Mineral Sunscreen 32 OZ ZINC OXIDE Sun Bum, LLC 3b2cb7cf-7e2c-0fd2-e063-6294a90a3b17 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Sunscreen Oil 50 5 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b2b4ba0-3f89-0a04-e063-6294a90ac1c0 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Signature Sunscreen Premium Zinc Lip Balm Broad Spectrum SPF 30 ZINC OXIDE Sun Bum, LLC 3ca9e9d3-1c73-7bd6-e063-6394a90ad204 2025-08-18 Warnings Exact identifier application number: M020 Ocean Potion Suncare Mineral 50 Essential Scent of Sunshine Zinc Oxide Continuous Sunscreen ZINC OXIDE GNL BRANDS INTERNATIONAL, LLC 3caaea85-0dfe-6f69-e063-6294a90a7d4a 2025-08-18 Warnings Exact identifier application number: M020 PLAY Lip Shield SPF 30 - Mint AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop LLC 3cab1a7d-6226-9eba-e063-6294a90a8c4d 2025-08-18 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