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

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:

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

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)  
CAESALPINIA 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 Product06/17/2022
2NDC:46783-100-151 in 1 CARTON05/01/2022
215 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:46783-100-501 in 1 CARTON05/01/2022
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 Product06/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM02005/01/2022
Labeler - Merz North America, Inc. (028147846)

Revised: 10/2023
Document Id: 6c0a1c72-e85b-455d-91ec-3587a4fbd785
Set id: 649c63a2-b25a-4092-88e4-fc668621e3a4
Version: 3
Effective Time: 20231023
 
Merz North America, Inc.