Journée Firm Broad Spectrum Sunscreen SPF 30

Journee Firm Broad Spectrum Sunscreen SPF 30 by

Drug Labeling and Warnings

Journee Firm Broad Spectrum Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Merz North America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

JOURNEE FIRM BROAD SPECTRUM SUNSCREEN SPF 30- titanium dioxide and zinc oxide cream 
Merz North America, Inc.

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Journée Firm Broad Spectrum Sunscreen SPF 30

Drug Facts:

Active Ingredients

Titanium Dioxide 12.25%
Zinc Oxide 10.2%

Purpose

Sunscreen

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.

Warnings

For external use only.

Do not use

  • on damaged or broken skin.

When using this product

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

Stop use and ask a doctor

  • if rash occurs.

Keep out of reach of children.

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

Directions

Apply generously 15 minutes before sun exposure. For children under 6 months of age, ask a doctor.

Sun-Protection Measures

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.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.

Inactive Ingredients

Water, Dimethicone, Coconut Alkanes, C12-15 Alkyl Benzoate, Isohexadecane, Ethyl Trisiloxane, Polyhydroxystearic Acid, PEG-10 Dimethicone, Isododecane, Glycerin, Butyloctyl Salicylate, Propanediol, Squalane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Zinc Sulfate, Caprylic/Capric Triglyceride, Cutaneous Lysate, Tetrapeptide-21, Capryloyl Carnosine, Caesalpinia Spinosa Fruit Pod Extract, Palmitoyl Tripeptide-1 Acetate, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Helianthus Annuus (Sunflower) Sprout Extract, Alumina, Caprylyl Methicone, Coco-Caprylate/Caprate, Stearic Acid, Polyglyceryl-3 Oleate, Stearalkonium Hectorite, C13-15 Alkane, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Polysilicone-11, Propylene Carbonate, Xanthan Gum, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Maltodextrin, Ethylhexylglycerin, Triethoxycaprylylsilane, PEG/PPG-18/18 Dimethicone, Melanin, Pentylene Glycol, Tocopherol, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499), Phenoxyethanol

Other Information

  • Protect this product from excessive heat and direct sun.

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

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

FOR PROFESSIONAL USE ONLY.
NOT FOR RESALE.

journée

F I R M

REVITALIZING &
REFINING DAY CREAM
BROAD SPECTRUM SPF 30

NEOCUTIS®

SHAKE WELL BEFORE USE

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label
JOURNEE FIRM BROAD SPECTRUM SUNSCREEN SPF 30 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 46783-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE12.25 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Dimethicone (UNII: 92RU3N3Y1O)  
Coconut Alkanes (UNII: 1E5KJY107T)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
Isohexadecane (UNII: 918X1OUF1E)  
Ethyl Trisiloxane (UNII: ZH1WJO5481)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
Isododecane (UNII: A8289P68Y2)  
Glycerin (UNII: PDC6A3C0OX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Propanediol (UNII: 5965N8W85T)  
Squalane (UNII: GW89575KF9)  
Polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate (UNII: 687U3PEB2Y)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HUMAN SKIN PROTEINS, PARTIALLY HYDROLYZED (UNII: G9813R29TW)  
Tetrapeptide-21 (UNII: 179JUC43HU)  
CARNOSINE (UNII: 8HO6PVN24W)  
TARA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
Palmitoyl Tripeptide-1 Acetate (UNII: 99B84UAK70)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Polyglyceryl-3 Oleate (UNII: XRQ165498B)  
Stearalkonium Hectorite (UNII: OLX698AH5P)  
C13-15 Alkane (UNII: 114P5I43UJ)  
Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate (UNII: G3232Z5S2O)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
Propylene Carbonate (UNII: 8D08K3S51E)  
Xanthan Gum (UNII: TTV12P4NEE)  
Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Maltodextrin (UNII: 7CVR7L4A2D)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)  
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
Pentylene Glycol (UNII: 50C1307PZG)  
Tocopherol (UNII: R0ZB2556P8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 46783-100-066 mL in 1 TUBE; Type 0: Not a Combination Product06/17/202202/28/2026
2NDC: 46783-100-151 in 1 CARTON05/01/202201/01/2025
215 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC: 46783-100-501 in 1 CARTON05/01/202201/01/2025
350 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC: 46783-100-20200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/17/202209/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM02005/01/202202/28/2026
Labeler - Merz North America, Inc. (028147846)

Revised: 7/2024