Label: JOURNEE FIRM BROAD SPECTRUM SUNSCREEN SPF 30- titanium dioxide and zinc oxide cream
- NDC Code(s): 46783-100-06, 46783-100-15, 46783-100-20, 46783-100-50
- Packager: Merz North America, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 23, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
-
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
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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.
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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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label
-
INGREDIENTS AND APPEARANCE
JOURNEE FIRM BROAD SPECTRUM SUNSCREEN SPF 30
titanium dioxide and zinc oxide creamProduct 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)
