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 213 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE BCM Cosmetique SAS 351251f5-e656-98b6-e063-6394a90ad805 2025-05-14 Warnings Exact identifier application number: M020 No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE BCM Cosmetique SAS 35129e6f-c6bd-a9f7-e063-6394a90ab0e4 2025-05-14 Warnings Exact identifier application number: M020 Noevir Raysela UV Shield Primer ZINC OXIDE, OCTINOXATE Nippon Shikizai, Inc. 45030b2f-21cf-4285-af12-87ea8f0b8df7 2025-05-14 Warnings Exact identifier application number: M020 OS-01 Lip SPF BS SPF15 ZINC OXIDE ONESKIN INC. 351d55f6-fcd9-1d47-e063-6294a90a2cf0 2025-05-14 Warnings Exact identifier application number: M020 NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM Port Jervis Laboratories, Inc. 350cd329-8fe2-314f-e063-6394a90ac954 2025-05-13 Warnings Exact identifier application number: M020 Lancer Mineral Sun Shield Universal Tint Broadspectrum SPF 30 ZINC OXIDE Lancer Skincare LLC 522a9158-2fd1-4634-adef-2ba84c86bcd7 2025-05-13 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Navajo Manufacturing Company Inc. 33f13aa4-9279-c251-e063-6294a90a2d67 2025-05-12 Warnings Exact identifier application number: M020 OS-01 FACE SPF BS SPF 30 TINTED DEEP ZINC OXIDE Allure Labs 34f51ff4-541d-2b2e-e063-6394a90a39da 2025-05-12 Warnings Exact identifier application number: M020 Bright Guard Natural SPF 30 ZINC OXIDE Renu Laboratories, LLC e7035fcd-6894-3360-e053-2a95a90a6f1d 2025-05-12 Warnings Exact identifier application number: M020 Bright Guard Sport SPF ZINC SPF RENU LABORATORIES, LLC c9b48a9e-d69f-65a7-e053-2995a90a0baf 2025-05-12 Warnings Exact identifier application number: M020 OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEP ZINC OXIDE Allure Labs 34f674c1-5d59-915a-e063-6394a90a6c2f 2025-05-12 Warnings Exact identifier application number: M020 Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment Broad Spectrum SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE AND OXYBENZONE Meaningful Beauty, LLC f59fe019-569b-49ba-accf-fa4d356ce96b 2025-05-12 Warnings Exact identifier application number: M020 Cicatricure Gold Lift SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Genomma Lab USA 34cc5b3c-af36-e202-e063-6294a90a13a7 2025-05-10 Warnings Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Maui Medical Group, Inc 34b6aa46-657b-2676-e063-6294a90abadd 2025-05-09 Exact identifier application number: M020 Tinted Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Scottsdale Skin Boutique and Dermatology Pllc 34a5a99f-9e22-52ab-e063-6294a90a9323 2025-05-08 Exact identifier application number: M020 Powder TITANIUM DIOXIDE Oxygen Development LLC 08b7eeeb-09ae-ffe6-e063-6294a90aba90 2025-05-07 Warnings Exact identifier application number: M020 cle de peau BEAUTE UV PROTECTIVE N AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Shiseido Americas Corporation fe19a057-a3c6-4c53-92f9-a4a960cd5b08 2025-05-07 Warnings Exact identifier application number: M020 Winter Survival Kit OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE Duke Cannon Supply Co. 2487ab56-7856-66b0-e063-6394a90a9d87 2025-05-07 Warnings Exact identifier application number: M020 OS-01 Lip SPF BS SPF15 ZINC OXIDE Allure Labs 3490ed60-60b9-dfcd-e063-6394a90ab17a 2025-05-07 Warnings Exact identifier application number: M020 Lip Love Moisture Balm SPF30 - Nude Beige ZINC OXIDE Koco Life LLC 3491084b-348a-f2bf-e063-6394a90abd25 2025-05-07 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