FDA.reportPublic FDA data

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

Manufacturer
Merz North America, Inc.
Effective date
2026-05-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:58:35

Label at a glance#

ProductJournee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn and premature skin aging. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun. Higher SPF gives more sunburn protection.

Dosage and administration

Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. For children under 6 months of age, ask a doctor. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad-Spectrum SPF value of 15 or higher and other sun-protection measures including: Limit ti...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts:

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Zinc Oxide 7.3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn and premature skin aging.
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Higher SPF gives more sunburn protection.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply generously 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • For children under 6 months of age, ask a doctor.

Sun-Protection Measures

SPL UNCLASSIFIED SECTION

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad-Spectrum SPF value of 15 or higher and other sun-protection measures including:

  • Limit time in the sun, especially from 10am-2pm.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Caprylic / Capric Triglyceride, Hydrogenated Poly (C6-14 Olefin), Hexyldecanol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Microcrystalline Cellulose, Camellia Sinensis Leaf Extract, Silica, Cutaneous Lysate, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Squalane, Hydroxyethyl Acrylate / Sodium Acryloyldimethyl Taurate Copolymer, Polyhydroxystearic Acid, Steareth-21, Melanin, Cetearyl Alcohol, Sodium Hyaluronate, Polysorbate 60, Triethoxycaprylysilane, Disodium EDTA, Xanthan Gum, Styrene / Acrylates Copolymer, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben

Other Information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Distributed in the USA by Merz North America, Inc.
Raleigh, NC 27615

PRINCIPAL DISPLAY PANEL - 15 ML Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

journée

REVITALIZING DAY CREAM
SPF 30

NEOCUTIS®

PRINCIPAL DISPLAY PANEL - 15 ML Bottle Carton
PRINCIPAL DISPLAY PANEL - 15 ML Bottle Carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixDataMatrixjournee-01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46783-002-01Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 301 in 1 CARTONLOTION18
46783-002-01Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 3015 mL in 1 BOTTLELOTION158
46783-002-02Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 301 in 1 CARTONLOTION18
46783-002-02Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 3030 mL in 1 BOTTLELOTION308
46783-002-03Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30200 mL in 1 BOTTLELOTION2008
46783-002-05Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 304 mL in 1 TUBELOTION48
46783-002-50Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 301 in 1 CARTONLOTION18
46783-002-50Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 3050 mL in 1 BOTTLELOTION508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46783-00246783-002-01, 46783-002-02, 46783-002-03, 46783-002-05, 46783-002-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
METHYLPARABENA2I8C7HI9TIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
ETHYLPARABEN14255EXE39IACT
PROPYLPARABENZ8IX2SC1OHIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 MONOSTEARATEYD01N1999RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
HEXYLDECANOL151Z7P1317IACT
STEARETH-2153J3F32P58IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYALURONATE SODIUMYSE9PPT4THIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MELANIN SYNTHETIC (TYROSINE, PEROXIDE)O0CV1RMR44IACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
SQUALANEGW89575KF9IACT
POLYSORBATE 60CAL22UVI4MIACT
HUMAN SKIN PROTEINS, PARTIALLY HYDROLYZEDG9813R29TWIACT
HYDROGENATED PALM GLYCERIDESYCZ8EM144QIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-10-07monthly-update2026-06-03 17:38:40
62024-11-01full-release2026-06-01 00:36:20

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30OCTINOXATE AND ZINC OXIDEMerz North America, Inc.e120a659-0dfc-42ca-8158-58e8a0b457e52026-05-20WarningsExact identifier
ndc (package): 46783-002-05
ndc (package): 46783-002-02
ndc (package): 46783-002-01
ndc (package): 46783-002-03
ndc (package): 46783-002-50
ndc (product): 46783-002
ndc11 (package): 46783000250
ndc11 (package): 46783000201
ndc11 (package): 46783000205
ndc11 (package): 46783000203
ndc11 (package): 46783000202
spl id: 7af0f836-c146-4bbf-b8e6-40e25f9a9723
spl set id: e120a659-0dfc-42ca-8158-58e8a0b457e5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.