JOURNEE FIRM BROAD SPECTRUM SUNSCREEN SPF 30- titanium dioxide and zinc oxide cream

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]

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

JOURNEE FIRM BROAD SPECTRUM SUNSCREEN SPF 30 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46783-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	12.25 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46783-100-06	6 mL in 1 TUBE; Type 0: Not a Combination Product	06/17/2022
2	NDC: 46783-100-15	1 in 1 CARTON	05/01/2022
2		15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 46783-100-50	1 in 1 CARTON	05/01/2022
3		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 46783-100-20	200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/17/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	05/01/2022

Labeler - Merz North America, Inc. (028147846)