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 74 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PROTEKT SPF-50 Sheer Mineral Sunscreen ZINC OXIDE Protekt Products, Inc. 6edc0941-bb21-4797-a875-81f727694774 2026-01-19 Warnings Exact identifier application number: M020 Ultra Violette SPF Mini Mates Duo Pocket Pals Ultra Violette SPF Mini Mates Duo Pocket Pals Contains 1 X Supreme Screen SPF50 20mL (84803-100-21) 1 X Future Screen SPF50 20mL (84803-103-21) ACTIVE INGREDIENTS SUPREME SCREEN SPF 50 AVOBENZONE 3% HOMOSALATE 7% OCTISALATE 5% OCTOCRYLENE 8% ACTIVE INGREDIENTS FUTURE SCREEN SPF 50 ZINC OXIDE 20% Grace and Fire USA Inc. 48c1b93c-9c6f-95aa-e063-6294a90a0cfa 2026-01-19 Warnings Exact identifier application number: M020 ANUA INVISIBLE GLOW FINISH SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE The Founders Inc. 446ac344-1078-4cd1-e063-6294a90a4bd4 2026-01-19 Warnings Exact identifier application number: M020 ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE The Founders Inc. 31af7b5e-2bd6-63ee-e063-6294a90a0806 2026-01-19 Warnings Exact identifier application number: M020 ANUA INVISIBLE MATTE FINISH SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE The Founders Inc. 4248deaf-ad55-a9b4-e063-6294a90a55cc 2026-01-19 Warnings Exact identifier application number: M020 ONSART Mineral Sunscreen ZINC OXIDE 24% Guangzhou Huixue Biotechnology Co., Ltd. 48c9d08d-9a91-7df5-e063-6294a90a1c4a 2026-01-19 Warnings Exact identifier application number: M020 Intense Moisture Day Cream AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE CVS Health 795d3546-f0dd-4b54-9807-9cdb3e626181 2026-01-19 Warnings Exact identifier application number: M020 CURESHIELD MANICURE SUNSCREEN ZINC OXIDE, TITANIUM DIOXIDE GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD 48b4fad7-073d-d983-e063-6394a90ae314 2026-01-18 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0CR Cool Fosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 65ff0448-17e6-42ce-989a-940794fcbd8c 2026-01-17 Warnings Exact identifier application number: M020 BenzoAzeline 10 BENZOYL PEROXIDE Noon Aesthetics M.R. Ltd 985efa19-bd91-45cd-a2a0-d71ec325e51c 2026-01-16 Warnings Exact identifier application number: M020 Prequel Lip Visor Berry SPF 30 PREQUEL LIP VISOR BERRY SPF 30 The Center Brands, LLC e4f3a0eb-4a8c-4145-92e4-979f03e3a511 2026-01-16 Warnings Exact identifier application number: M020 Prequel Lip Visor Blush SPF 30 PREQUEL LIP VISOR BLUSH SPF 30 The Center Brands, LLC bc681245-e158-4cfa-9718-7ec4cff0e60d 2026-01-16 Warnings Exact identifier application number: M020 Prequel Lip Visor Mahogany SPF 30 PREQUEL LIP VISOR MAHOGANY SPF 30 The Center Brands, LLC ea8dcd14-3c54-46a6-aabc-3655f051065b 2026-01-16 Warnings Exact identifier application number: M020 Prequel Lip Visor Nude SPF 30 PREQUEL LIP VISOR NUDE SPF 30 The Center Brands, LLC 03a7c77d-7b6e-4720-88f1-492ce57c7145 2026-01-16 Warnings Exact identifier application number: M020 Valmont Daily Veil Moisturizing Face Fluid Mineral Sunscreen SPF 30 ZINC OXIDE CVL Cosmetics North America Inc f3057856-1461-41d3-a5c4-9f12e3a4a0ee 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 04e9c4d8-1600-4ffc-8578-4ffb82b106f3 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 1d6f10b7-60b9-47f6-9dba-1dd0a7cf6f5d 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 1aae19da-1e73-41ed-91dc-0746ad311b87 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6,5W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 22d4452d-3798-48c6-a7a4-4af0f99b4ebd 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior d6800bb7-16ef-48f6-a09a-0422e64ad8bd 2026-01-16 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