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 185 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sun Bum Daily Body AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 15da0cb1-e695-cec3-e063-6394a90a1afa 2025-09-23 Warnings Exact identifier application number: M020 Sun Bum Daily Face Liquid Sunscreen Moisturizer Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 15daac41-54b6-096d-e063-6294a90a0736 2025-09-23 Warnings Exact identifier application number: M020 Mtn. Bum by Sun Bum and Mcfetridge Mineral Sunscreen Face Stick SPF 50 ZINC OXIDE Sun Bum, LLC 3f8101b1-297d-2ad8-e063-6294a90a9cff 2025-09-23 Warnings Exact identifier application number: M020 Sun Bum Daily Glow Tinted Sunscreen Moisturizer Broad Spectrum SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 20c48752-3ad9-5993-e063-6294a90ae1b0 2025-09-23 Warnings Exact identifier application number: M020 CVS SPF 60 Face Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CVS 26d1b568-ad9c-80d7-e063-6394a90a2cbf 2025-09-21 Warnings Exact identifier application number: M020 Radiant Shield Tinted Mineral Sunscreen SPF 40 ZINC OXIDE CosMedical Technologies, LLC f229b928-49fd-4e02-99c1-b2cd9166894f 2025-09-19 Warnings Exact identifier application number: M020 EquateDaytimeFaceLotion EQUATE DAYTIME FACE LOTION WITH SUNSCREEN, SPF 30, 3 OZ Walmart Inc. 2efc7087-f4ad-2f2e-e063-6394a90a1302 2025-09-18 Warnings Exact identifier application number: M020 ERBORIAN CC RED CORRECT ERBORIAN CC RED CORRECT SPF 25- OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM Kolmask Co., Ld. 09ca2d4b-e0c2-9961-e063-6394a90aa82e 2025-09-18 Exact identifier application number: M020 ELROEL Pang Pang Sun Cushion Plus ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE MONOGLOT HOLDINGS Inc. 5ffaad65-f0b2-416a-b0a3-b92e880641e4 2025-09-18 Warnings Exact identifier application number: M020 e.l.f. Camo CC Cream SPF 30 Fair 125 C HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE e.l.f. Cosmetics, Inc. 407f9c0d-31c6-f5bb-e063-6394a90a4db4 2025-09-18 Warnings Exact identifier application number: M020 Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC 1630feee-7e0d-c6f4-e063-6294a90a7b1c 2025-09-17 Warnings Exact identifier application number: M020 Guise Tinted Drops ZINC OXIDE Donis Men LLC 3f039049-5004-2888-e063-6294a90a5150 2025-09-17 Warnings Exact identifier application number: M020 ONE SIZE ON TIL DAWN ONE SIZE ON TIL DAWN Pogi Beauty LLC 3f05d90b-9274-4d21-e063-6294a90a8485 2025-09-17 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint DP3 ZINC OXIDE PUR Minerals 3f073413-b314-e5da-e063-6394a90a9ab4 2025-09-17 Warnings Exact identifier application number: M020 e.l.f. Hydrating Camo CC Cream SPF30 Fair 100 W HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE e.l.f. Cosmetics, Inc. 3fa7ef54-2c4d-9883-e063-6294a90a8d88 2025-09-17 Warnings Exact identifier application number: M020 CVS SPF 50 Face Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CVS 26a69a47-947a-a478-e063-6394a90aa468 2025-09-16 Warnings Exact identifier application number: M020 SkinSuit TM 3 in 1 Moisturizer SPF 50 ZINC OXIDE Skin Authority LLC 5eb27be9-9e80-4f4a-b193-b918d831555d 2025-09-15 Warnings Exact identifier application number: M020 Sun and Honey Tallow Sunscreen SPF 30 ZINC OXIDE Amara Ventures 3eda8a70-7c9e-e920-e063-6394a90a85a2 2025-09-15 Warnings Exact identifier application number: M020 Klein Tools Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE KLEIN TOOLS, INC. 3edcc26a-d960-3fa8-e063-6394a90ab703 2025-09-15 Warnings Exact identifier application number: M020 Klein Tools Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTOCRYLENE KLEIN TOOLS, INC. 3ede5e54-4c9f-02f7-e063-6294a90a9df6 2025-09-15 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