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 220 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Superactive Moisturizer SPF 50 Brightening SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Murad, LLC 4ff8525a-4526-4acf-86c7-88f1f1073274 2025-03-26 Warnings Exact identifier application number: M020 Lip Balm SPF15 Unflavored LIP BALM SPF15 LS Promotions Inc 3131632d-735c-6688-e063-6294a90a0239 2025-03-26 Warnings Exact identifier application number: M020 Lip Balm SPF15 Chocolate Sundae flavored LIP BALM SPF15 LS Promotions Inc 3142f352-ee65-47b5-e063-6394a90ada57 2025-03-26 Warnings Exact identifier application number: M020 Lip Balm SPF15 Pina Colada flavored LIP BALM SPF15 PINA COLADA FLAVORED LS Promotions Inc 31440153-e7ca-1327-e063-6294a90a562c 2025-03-26 Warnings Exact identifier application number: M020 CVS Health Sport 100 Clear AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CVS PHARMACY 0a245b1b-eaf6-7011-e063-6294a90ab68f 2025-03-26 Warnings Exact identifier application number: M020 Lip Balm SPF15 Apple Pie flavored LIP BALM SPF15 APPLE PIE FLAVORED LS Promotions Inc 3145bd6d-0ece-e9d5-e063-6294a90afb9d 2025-03-26 Warnings Exact identifier application number: M020 HEB Glow 40 Tinted Sunscreen Face Primer AVOBENZONE, OCTISALATE, OCTOCRYLENE H.E.B. 3146bcd9-d562-9ba6-e063-6294a90a37aa 2025-03-26 Warnings Exact identifier application number: M020 HEB 50 Clear Mineral Clear Zinc Oxide Sunscreen ZINC OXIDE H.E.B. 3146fb5f-1fb5-f09f-e063-6294a90a6206 2025-03-26 Warnings Exact identifier application number: M020 HEB 50 Glow Body Oil Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B. 31473cc9-08f5-39e3-e063-6294a90aa499 2025-03-26 Warnings Exact identifier application number: M020 HEB 50 Clear Mineral Clear Zinc Oxide Sunscreen ZINC OXIDE H.E.B. 314776a8-a562-3dd2-e063-6394a90ab1b9 2025-03-26 Warnings Exact identifier application number: M020 TRADER JOES INVISIBLE BODY SUNSCREEN SPF 40 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Trader Joe's Company 31478f5a-88f4-4b01-e063-6394a90a04b7 2025-03-26 Warnings Exact identifier application number: M020 TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Trader Joe's Company 3147c08f-c3f2-aef1-e063-6294a90a5c44 2025-03-26 Warnings Exact identifier application number: M020 HEB SPF 50 Mangonada Scented Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B 3147ef18-9029-6d5b-e063-6394a90acee0 2025-03-26 Warnings Exact identifier application number: M020 HEB SPF 50 Mexican Vanilla Scented Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B 31487bad-a756-9050-e063-6394a90acacc 2025-03-26 Warnings Exact identifier application number: M020 TRADER JOES DAILY FACIAL MINERAL SUNSCREEN SPF 40 ZINC OXIDE Trader Joe's Company 3148c00f-21bb-c05f-e063-6394a90af0e8 2025-03-26 Warnings Exact identifier application number: M020 HEB SPF 50 Chamomile and Lavender Scented Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B 314b8147-fe7a-0698-e063-6394a90a872c 2025-03-26 Warnings Exact identifier application number: M020 HEB SPF 50 Shine Sunscreen with Vitamin C Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B 314bcf42-ca01-0fa5-e063-6294a90a5fc8 2025-03-26 Warnings Exact identifier application number: M020 Superactive Moisturizer SPF 50 Hydrating SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Murad, LLC 1e5d494b-dccf-4ba1-89de-0bb4ba5b8d38 2025-03-26 Warnings Exact identifier application number: M020 Superactive Moisturizer SPF 50 Wrinkle Fighting SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Murad, LLC ac6163fb-dbc1-432f-a590-86d31c93b29b 2025-03-26 Warnings Exact identifier application number: M020 it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep FairLight Neutral Tan Rich Honey LightMedium and Neutral Medium TITANIUM DIOXIDE AND ZINC OXIDE IT COSMETICS, LLC e17dc640-30e9-441b-a212-ef1508af7944 2025-03-25 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