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 264 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 8a542b3c-c3c0-465a-9b24-6a62016656f3 2024-11-25 Warnings Exact identifier application number: M020 CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 CLARO 110C OCTINOXATE, ZINC OXIDE BEL STAR S A 27c30645-dcef-bc31-e063-6394a90a1368 2024-11-25 Warnings Exact identifier application number: M020 SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15 OCTINOXATE AND TITANIUM DIOXIDE Bobbi Brown Professional Cosmetics Inc. b669c36d-4c94-455d-8534-9c3bb024d668 2024-11-25 Warnings Exact identifier application number: M020 VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15 VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15 Bobbi Brown Professional Cosmetics Inc. eecb05ab-2048-6e8d-e053-2995a90a8280 2024-11-22 Warnings Exact identifier application number: M020 Covergirl Outlast Extreme Wear 3-in-1 Foundation 24 HR Full Coverage SPF 18 Octinoxate Sunscreen Liquid Foundation OCTINOXATE Noxell Corporation 258e8f05-295e-8e32-e063-6294a90a7548 2024-11-21 Warnings Exact identifier application number: M020 MILKY MINERAL SUN SERUM TITANIUM DIOXIDE AND ZINC OXIDE Synchronicity Spa, Inc. DBA Suntegrity 53834c89-b3b4-4e21-b9f6-19f95e78ba83 2024-11-21 Warnings Exact identifier application number: M020 NATURAL MOISTURIZING FACE SUNSCREEN and PRIMER ZINC OXIDE Synchronicity Spa, Inc. DBA Suntegrity 5996f9b2-18c1-4c8f-a0ab-eca180db61ad 2024-11-21 Warnings Exact identifier application number: M020 NATURAL MINERAL BODY SUNSCREEN ZINC OXIDE Synchronicity Spa, Inc. DBA Suntegrity dc5116d4-3a42-44d4-b41a-e88b5b16d111 2024-11-21 Warnings Exact identifier application number: M020 IMPECCABLE SKIN - IVORY ZINC OXIDE Synchronicity Spa, Inc. DBA Suntegrity 98a7896e-4b03-4184-ac2e-6b49e47c0bc4 2024-11-21 Warnings Exact identifier application number: M020 1177, 1178 Sunscreen 1177, 1178 SUNSCREEN Dynarex c3142ddb-74ea-a7d1-e053-2a95a90a26f3 2024-11-20 Warnings Exact identifier application number: M020 Covergirl Aquasmooth Broadspectrum SPF 20 All shades TITANIUM DIOXIDE Noxell Corporation 952ea869-581e-4503-9f21-a77d061a417d 2024-11-20 Warnings Exact identifier application number: M020 Covergirl TruBlend Base Business Everyday Defense Primer SPF 20 ENSULIZOLE NOXELL CORPORATION 8528aa01-fd4b-58a6-e053-2991aa0a3d6a 2024-11-20 Warnings Exact identifier application number: M020 Facial Skin Shield Broad Spectrum SPF50 Plus AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE AHAVA - Dead Sea Laboratories Ltd bb62c700-be07-4fe3-b007-425a5f760b30 2024-11-20 Warnings Exact identifier application number: M020 FOUNDATION LIGHT SPECTRUM OCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDE Guangzhou Bo win Trade Co., Ltd. 273ea785-241b-3e10-e063-6294a90a9fff 2024-11-19 Warnings Exact identifier application number: M020 FOUNDATION MEDIUM SPECTRUM OCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDE Guangzhou Bo win Trade Co., Ltd. 273f4d65-b245-c27a-e063-6394a90ade07 2024-11-19 Warnings Exact identifier application number: M020 Pool Bar London Not Just a Pretty Face Sunscreen SPF 50 ZINC OXIDE POOLBAR c081acef-9e1d-4aa6-b49c-c92fe28af2c7 2024-11-19 Warnings Exact identifier application number: M020 Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 30 Coconut and Vanilla Scented ZINC OXIDE POOLBAR 3a481521-e209-4c86-895f-2e7392b7c565 2024-11-19 Warnings Exact identifier application number: M020 Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 50 Coconut and Vanilla Scented ZINC OXIDE POOLBAR 1721023c-3321-4f0b-a053-6d0c657fa1b0 2024-11-19 Warnings Exact identifier application number: M020 Theraderm Platinum Protection Facial Sunscreen SPF 40 OCTOCRYLENE, OCTISALATE, ZINC OXIDE Therapon Inc 1fea6ad8-4d33-4f7c-800c-1bee644bd97f 2024-11-19 Warnings Exact identifier application number: M020 Fresh Monster Mineral Sunscreen ZINC OXIDE Blue Zebra Brands, Inc. 230cc36d-5163-f423-e063-6394a90a8124 2024-11-19 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