JOURNEE RICHE BIO-RESTORATIVE DAY BALM BROAD-SPECTRUM SUNSCREEN SPF 30- octinoxate and zinc oxide lotion 
Merz North America, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Journée Riche Bio-restorative Day Balm Broad-spectrum Sunscreen SPF 30

Drug Facts

Active ingredients

Octinoxate 7.5%

Zinc Oxide 7.3%

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.

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.

See package insert for complete information.

Directions

  • Apply generously 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this 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.
  • Children under 6 months of age, ask a doctor

Inactive ingredients

Water, Hydrogenated Polyisobutene, Petrolatum, Caprylic/Capric Triglyceride, Hexyldecanol, Isododecane, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrogenated Palm Glycerides, Microcrystalline Cellulose, Dioscorea Villosa (Wild Yam) Root Extract, Camellia Sinensis Leaf Extract, Silica, Cutaneous Lysate (PSP®), Butylene Glycol, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Squalane, Polyhydroxystearic Acid, Steareth-21, Melanin, Cetearyl Alcohol, Sodium Hyaluronate, Polysorbate 60, Triethoxycaprylsilane, Polysilicone-11, Disodium EDTA, Xanthan Gum, Cellulose Gum, Styrene/Acrylates Copolymer, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben.

Other information

  • Protect this product from excessive heat and direct sun.

Distributed in the USA by Merz North America, Inc.

PRINCIPAL DISPLAY PANEL - 15 ML Bottle Carton

journée
RICHE

EXTRA MOISTURIZING
REVITALIZING DAY CREAM
SPF 30

NEOCUTIS®

PRINCIPAL DISPLAY PANEL - 15 ML Bottle Carton
JOURNEE RICHE BIO-RESTORATIVE DAY BALM BROAD-SPECTRUM SUNSCREEN SPF 30 
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46783-175
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.3 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
PETROLATUM (UNII: 4T6H12BN9U)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HEXYLDECANOL (UNII: 151Z7P1317)  
ISODODECANE (UNII: A8289P68Y2)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HUMAN SKIN PROTEINS, PARTIALLY HYDROLYZED (UNII: G9813R29TW)  
SQUALANE (UNII: GW89575KF9)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
STEARETH-21 (UNII: 53J3F32P58)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46783-175-051 in 1 CARTON05/18/201505/31/2023
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:46783-175-101 in 1 CARTON05/18/201505/18/2015
230 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:46783-175-151 in 1 CARTON05/18/201505/31/2023
350 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:46783-175-011 mL in 1 PACKET; Type 0: Not a Combination Product05/18/201507/01/2020
5NDC:46783-175-044 mL in 1 TUBE; Type 0: Not a Combination Product05/18/201505/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35205/18/201505/31/2023
Labeler - Merz North America, Inc. (028147846)

Revised: 6/2023
 
Merz North America, Inc.