Home NDC 46783-002 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30
Product NDC 46783-002
11-digit product format 467830002
Labeler code 46783
Product ID 46783-002_d1d2fc30-392b-481c-b1ad-b6fe86b3f8a4
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE and ZINC OXIDE
Dosage form LOTION
Route TOPICAL
Labeler Merz North America, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-04-01
Substance OCTINOXATE; ZINC OXIDE
Active strength 75; 73 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 75 mg/mL ZINC OXIDE 73 mg/mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46783-002-01 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 1 in 1 CARTON LOTION 1 8 46783-002-01 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 15 mL in 1 BOTTLE LOTION 15 8 46783-002-02 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 1 in 1 CARTON LOTION 1 8 46783-002-02 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 30 mL in 1 BOTTLE LOTION 30 8 46783-002-03 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 200 mL in 1 BOTTLE LOTION 200 8 46783-002-05 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 4 mL in 1 TUBE LOTION 4 8 46783-002-50 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 1 in 1 CARTON LOTION 1 8 46783-002-50 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 50 mL in 1 BOTTLE LOTION 50 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46783-002 JOURNEE BIO-RESTORATIVE DAY BALM BROAD-SPECTRUM SUNCREEN SPF 30 (OCTINOXATE AND ZINC OXIDE) LOTION [MERZ NORTH AMERICA, INC.] 6 Current NDC, Legacy NDC, 8 package rows 20241109_e120a659-0dfc-42ca-8158-58e8a0b457e5.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 258 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Everyday Coverage Tinted Sunscreen - Extra Light Tint ZINC OXIDE MV Advanced 7834c649-5f6d-b005-e053-2a91aa0a1084 2024-12-12 Warnings Exact identifier application number: M020 Everyday Coverage Tinted Sunscreen - Light Tint ZINC OXIDE MV Advanced 783649af-d746-84a3-e053-2991aa0a9e3d 2024-12-12 Warnings Exact identifier application number: M020 Everyday Coverage Tinted Sunscreen - Medium Tint ZINC OXIDE MV Advanced 783649af-d768-84a3-e053-2991aa0a9e3d 2024-12-12 Warnings Exact identifier application number: M020 Babo SPF 30 Clear Zinc Fragrance Free Sport MINERAL SUNSCREEN Babo Botanicals, Inc. b1a9f76d-0cef-29da-e053-2995a90af34c 2024-12-12 Warnings Exact identifier application number: M020 Babo Baby Face Mineral Sunscreen MINERAL SUNSCREEN Babo Botanicals, Inc. b131664d-1ad2-0a2f-e053-2995a90acbda 2024-12-12 Warnings Exact identifier application number: M020 Babo SPF 30 Clear Zinc Fragrance Free MINERAL SUNSCREEN Babo Botanicals, Inc. b3e40cb0-dbfd-955c-e053-2995a90af848 2024-12-12 Warnings Exact identifier application number: M020 DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 ZINC OXIDE BABOR Cosmetics America Corp 291ec801-ee15-06a4-e063-6294a90ab32b 2024-12-12 Warnings Exact identifier application number: M020 All Calm Clinical Redness Corrector SPF 50 TITANIUM DIOXIDE AND ZINC OXIDE Colorescience 68b95e94-3686-4d11-9952-ec86394376ee 2024-12-12 Warnings Exact identifier application number: M020 Method Men Face with Zinc Oxide Sunscreen ZINC OXIDE Method Products Inc. cce5f8e1-cf40-4524-af2b-1d49309e2809 2024-12-12 Warnings Exact identifier application number: M020 Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Colorescience 219e2ef4-e977-4527-8999-14b27d5a7a33 2024-12-12 Warnings Exact identifier application number: M020 Absolutely Natural Broad Spectrum SPF 50Plus Sunscreen ZINC OXIDE Absolutely Natural 4855c2c7-1516-4857-b103-2eb72a60d5d0 2024-12-11 Warnings Exact identifier application number: M020 Absolutely Natural Broad Spectrum SPF 30 Sunscreen ZINC OXIDE Absolutely Natural b6e8f361-fd31-4f21-9095-c5159a826175 2024-12-11 Warnings Exact identifier application number: M020 Walgreens Scar Cream w/SPF 30 AVOBENZONE3%,OCTOCRYLENE10%,OXYBENONE 6% Walgreens cc72c8c5-f3e9-e8e0-e053-2a95a90ae0b0 2024-12-11 Warnings Exact identifier application number: M020 ERBORIAN - BB CREME AU GINSENG CLAIR SPF 20 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L ee9ae84b-c8fc-4a87-8910-46ec8ccfe1a9 2024-12-11 Warnings Exact identifier application number: M020 ERBORIAN - BB CREME AU GINSENG DORE SPF 20 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 121aa873-5ca6-426b-8ece-dcb5a9f82a03 2024-12-11 Warnings Exact identifier application number: M020 ERBORIAN - CC CREME HIGH DEFINITION SPF 25 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 3421b9a3-6551-406f-af3a-b3da8a01d2b2 2024-12-11 Warnings Exact identifier application number: M020 ERBORIAN CC RED CORRECT SPF 25 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE Laboratoires M&L 21530925-03b7-40bb-9836-6ee4011c4a79 2024-12-11 Warnings Exact identifier application number: M020 ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 70a5537c-a364-4dae-8ab2-8ca0cbfd11b7 2024-12-11 Warnings Exact identifier application number: M020 ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L b55be8cb-7f21-45b0-bb8f-a60182077ca3 2024-12-11 Warnings Exact identifier application number: M020 I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Deep Honey ZINC OXIDE AND TITANIUM DIOXIDE Allure Labs dc792777-d8b6-3ebc-e053-2a95a90abc3f 2024-12-11 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 46783-002-01 46783000201 1 BOTTLE in 1 CARTON (46783-002-01) / 15 mL in 1 BOTTLE 1 bottle 2011-04-01 0000-00-00 No No Current 46783-002-02 46783000202 1 BOTTLE in 1 CARTON (46783-002-02) > 30 mL in 1 BOTTLE 1 bottle 2011-04-01 0000-00-00 No No Current 46783-002-03 46783000203 200 mL in 1 BOTTLE (46783-002-03) 200 ml 2011-04-01 0000-00-00 No No Current 46783-002-05 46783000205 4 mL in 1 TUBE (46783-002-05) 4 ml 2011-04-01 0000-00-00 No No Current 46783-002-50 46783000250 1 BOTTLE in 1 CARTON (46783-002-50) > 50 mL in 1 BOTTLE 1 bottle 2019-06-18 0000-00-00 No No Current