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_7af0f836-c146-4bbf-b8e6-40e25f9a9723
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
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 33 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Target Up and Up SPF 50 Coconut Scented Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TARGET CORPORATION 51510195-a577-dce4-e063-6294a90a3e74 2026-05-08 Warnings Exact identifier application number: M020 Target Up and Up SPF 50 Watermelon Scented Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TARGET CORPORATION 5151493a-c25a-fb59-e063-6394a90a1034 2026-05-08 Warnings Exact identifier application number: M020 Target Up and Up SPF 50 Strawberry Scented Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TARGET CORPORATION 51512b9f-514d-3a29-e063-6294a90ae173 2026-05-08 Warnings Exact identifier application number: M020 Target Up and Up SPF 50 Peony Scented Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TARGET CORPORATION 5151560f-350c-88c3-e063-6294a90a3492 2026-05-08 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5.5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior bb65c8d7-318f-4d52-9d74-ca22ce389638 2026-05-07 Warnings Exact identifier application number: M020 Ciele lip and PROTECT lipstick SPF 60 Cassette CIELE LIP AND PROTECT LIPSTICK SPF 60 CASSETTE LE COSMETICS INC 5139cc37-62ac-514b-e063-6394a90a9ca3 2026-05-07 Warnings Exact identifier application number: M020 Ciele lip and PROTECT lipstick SPF 60 Kelly CIELE LIP AND PROTECT LIPSTICK SPF 60 KELLY LE COSMETICS INC 5139d3c1-83d1-2ad9-e063-6394a90a6958 2026-05-07 Warnings Exact identifier application number: M020 Ciele lip and PROTECT lipstick SPF 60 Margaux CIELE LIP AND PROTECT LIPSTICK SPF 60 MARGAUX LE COSMETICS INC 5138eb74-0223-6c1f-e063-6294a90a3bc6 2026-05-07 Warnings Exact identifier application number: M020 Ciele lip and PROTECT lipstick SPF 60 Bonnie CIELE LIP AND PROTECT LIPSTICK SPF 60 BONNIE LE COSMETICS INC 513a0449-5494-5dfd-e063-6394a90a026e 2026-05-07 Warnings Exact identifier application number: M020 Ciele lip and PROTECT lipstick SPF 60 LouLou CIELE LIP AND PROTECT LIPSTICK SPF 60 LOULOU LE COSMETICS INC 5139dab1-3c27-a59e-e063-6294a90a7096 2026-05-07 Warnings Exact identifier application number: M020 Ciele lip and PROTECT lipstick SPF 60 Puzzle CIELE LIP AND PROTECT LIPSTICK SPF 60 PUZZLE LE COSMETICS INC 513a0722-42ab-1051-e063-6294a90a8a1d 2026-05-07 Warnings Exact identifier application number: M020 Ciele lip and PROTECT lipstick SPF 60 Saddle CIELE LIP AND PROTECT LIPSTICK SPF 60 SADDLE LE COSMETICS INC 513a12cf-0230-6a24-e063-6394a90afb95 2026-05-07 Warnings Exact identifier application number: M020 Target Up and Up SPF 50 Banana Scented Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TARGET CORPORATION 513bdfb1-6b90-dfc7-e063-6394a90a9ec2 2026-05-07 Warnings Exact identifier application number: M020 Zinc Oxide 20.00% SPF 50 MINERAL Coconut Caliente Costa Rica LLC 388f1e01-0feb-4c94-88a7-13c81368c6c8 2026-05-07 Warnings Exact identifier application number: M020 SPF 50 Kids Sunscreen HOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3% Coconut Caliente Costa Rica LLC 9839570f-eeef-4140-a6ca-9fd2c9767a5b 2026-05-07 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4.5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 67b90f00-4c82-40cd-af96-f8dedf95f8af 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 7a2bd17d-0ea7-4326-9939-a747869c01d2 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior a396c0eb-f91f-4732-9c20-6b25aa0634b7 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 18b21fba-f6ee-4ac5-a536-096716f51da0 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 13c34bba-f939-4aa7-9457-9d6025902e06 2026-05-06 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