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 204 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Counter Beauty Daily Sheer Defense SPF 25 ZINC OXIDE G2G Ventures, PBC 3a22d88b-cdb5-5656-e063-6294a90a5b77 2025-07-17 Warnings Exact identifier application number: M020 Counter Beauty Dew Skin Tinted Moisturizer No. 1 ZINC OXIDE G2G Ventures, PBC 3a2676ed-087d-f957-e063-6294a90ad457 2025-07-17 Warnings Exact identifier application number: M020 Sjolie Tanning SPF 30 Sunscreen ZINC OXIDE SJOLIE, INC. 3a283a09-2edb-f92c-e063-6294a90a82bd 2025-07-17 Warnings Exact identifier application number: M020 Neutrogena Clear Body Breakout Free Oil Free Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 32889c1e-d539-4b36-b012-9789c4a8d642 2025-07-16 Warnings Exact identifier application number: M020 GZE Tinted Sunscreen ZINC OXIDE 3% Guangzhou Yilong Cosmetics Co.,Ltd. 182612d8-76a4-44a1-e063-6394a90a8d5f 2025-07-15 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Face Serum Sunscreen Broad Spectrum SPF 60 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 089b798b-829f-aa86-e063-6294a90a8631 2025-07-15 Warnings Exact identifier application number: M020 MO HANDSOME Protection Sport Sunscreen SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE 8 PINE DESIGN LLC 982ada30-5f87-42c6-b9ea-fedd842aa09d 2025-07-15 Warnings Exact identifier application number: M020 Amarte ULTRA VEIL Daily SUNSCREEN Amarte USA LLC 39e9ca98-d0e8-6b8f-e063-6394a90aa366 2025-07-15 Warnings Exact identifier application number: M020 Amarte ULTRA VEIL BB Fair SUNSCREEN Amarte USA LLC 39e87950-4103-c2eb-e063-6394a90a0552 2025-07-15 Warnings Exact identifier application number: M020 LEBELAGE UV SUN ULTRA SHIELD SUNSTICK AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATE DONGDONGGURIMOO CO.,LTD. 39eea41c-8703-cf1f-e063-6394a90a5b1f 2025-07-14 Warnings Exact identifier application number: M020 Basin Vanilla SPF 30 Lip Balm SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Retail Concepts of Minnesota, Inc. 4a8e7be0-97a6-ada5-e063-6294a90ae25a 2025-07-14 Warnings Exact identifier application number: M020 Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 48980ef3-ebda-450e-9f15-effad27dec9a 2025-07-11 Warnings Exact identifier application number: M020 KLARINA Sheer Mineral Sunscreen Blender SPF 50 ZINC OXIDE KLARINA INC 081941e3-02da-43a2-bf6f-a6d0f053272f 2025-07-10 Warnings Exact identifier application number: M020 ATHLETIC COSMETIC COMPANY Clear Power Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ATHLETIC COSMETIC COMPANY LLC f143a8e0-b32b-4b14-a6ae-f013627b484c 2025-07-10 Warnings Exact identifier application number: M020 Venofye Orchard Bee Brilliance SPF 30 OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE Innovation Brands Inc. 7c36c7e5-bc0b-40e6-bdbc-fd34f0b0eafe 2025-07-10 Warnings Exact identifier application number: M020 Touch Anti-Aging SPF 30 Moisturizer ZINC OXIDE, OCTINOXATE, AND OCTISALATE Diractions Capital LLC 47ce948e-5848-43a1-880e-aeb78e9ad1b3 2025-07-10 Warnings Exact identifier application number: M020 La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 06f2ced8-273e-454f-92b4-2846f6674b37 2025-07-10 Warnings Exact identifier application number: M020 SPF30 unseen sunscreen 01 BUTYL METHOXYDIBENZOYLMETH, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE Cosmuses Cosmetics (Ningbo) Co., Ltd. 398bb1f5-80ea-c589-e063-6294a90abefd 2025-07-09 Warnings Exact identifier application number: M020 Prada Reveal Skin Optimizing Foundation Broad Spectrum SPF 17 Sunscreen ENSULIZOLE SICOS ET CIE 1ac50772-0bea-4a41-8300-03f65f0bed52 2025-07-09 Warnings Exact identifier application number: M020 Prada Reveal Skin Optimizing Foundation Broad Spectrum SPF 17 Sunscreen ENSULIZOLE L'Oreal USA Products Inc e74a8c43-ec70-4de1-b2b5-0e89e40bfb40 2025-07-08 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