Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30

Product NDC: 46783-002
Requested package NDC: 46783-002-01
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

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	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 92 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Royal Jelly Radiance Foundation Broad Spectrum SPF 20 Earth	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	0edc7bd4-9350-48e1-bbfe-e6450458ae59	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Bronze	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	90fbf555-106c-4131-b572-ead9bbb246e6	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Honey	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	1accbe67-c722-4af7-8422-0559ac4a987a	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Bare	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	5c0805c7-9b92-4c08-877c-64e720308430	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20- Natural	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	0cc5429d-ace4-4060-b993-1b607218eaf8	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20-Nude	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	b1851c5d-32ad-482a-bd24-2f280a68ef9e	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 -Spice	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	6164dc23-81c2-48b8-b309-2c5a81fe13a4	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Light Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4744e501-f12a-6d25-e063-6394a90a2574	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Tawny	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	d7c4e758-3af2-40c6-bbe1-37e6fd0a5eb6	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Cappuccino	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	30601a73-089e-4fa7-8fb7-6b108498934a	2025-12-31	Warnings	Exact identifier application number: M020
Good Karma Dry Oil Mineral Sunscreen SPF-30	ZINC OXIDE SUNSCREEN	SOLARA SUNCARE, INC.	209c4913-29e6-24ca-e063-6294a90a6872	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47456bf5-9f6c-e6a5-e063-6294a90a7054	2025-12-31	Warnings	Exact identifier application number: M020
Olay Age Defying Classic Daily Renewal Broad Spectrum SPF 15	OCTINOXATE AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	60183a47-fd02-052b-e053-2991aa0a1b5c	2025-12-31	Warnings	Exact identifier application number: M020
Native Mineral Sunscreen Broad Spectrum SPF 30 Sweet Peach and Nectar	ZINC OXIDE	The Procter & Gamble Manufacturing Company	026dcaee-d33c-b874-e063-6394a90ad2e7	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4745ab56-abaa-42de-e063-6394a90a6310	2025-12-31	Warnings	Exact identifier application number: M020
Olay Complete Plus Daily Facial Moisturizer with Sunscreen Broad Spectrum SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	22f645cf-5182-9e3f-e063-6394a90adc84	2025-12-31	Warnings	Exact identifier application number: M020
Native Mineral Sunscreen Broad Spectrum SPF 30 Tropical Breeze	ZINC OXIDE	The Procter & Gamble Manufacturing Company	232032b7-803f-40ec-e063-6394a90a4b38	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 100	AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%	Beiersdorf Inc	e1a9a831-a0b9-17ba-e053-2a95a90a3fa7	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4745ebec-acb0-77c4-e063-6394a90aee07	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Baby Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	08134b95-1879-27e5-e063-6294a90a29af	2025-12-31	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Journée Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30	Merz North America, Inc.	2026-10-12	HUMAN OTC DRUG LABEL	9