JOURNEE RICHE BIO-RESTORATIVE DAY BALM BROAD-SPECTRUM SUNSCREEN SPF 30- octinoxate and zinc oxide lotion

Journee Riche Bio-restorative Day Balm Broad-spectrum Sunscreen SPF 30 by

Drug Labeling and Warnings

Journee Riche Bio-restorative Day Balm 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

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.

SPL UNCLASSIFIED SECTION

Distributed in the USA by Merz North America, Inc.

PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton

BIOESSENTIALS

JOURNÉE
RICHE
Bio-restorative Day Balm
Broad-spectrum
Sunscreen SPF 30
NEO

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NEOCUTIS
Exclusive Swiss Technology
available through physicians

1 FL. OZ. (30 ML)

INGREDIENTS AND APPEARANCE

JOURNEE RICHE BIO-RESTORATIVE DAY BALM BROAD-SPECTRUM SUNSCREEN SPF 30 
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46783-175
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.3 mg  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46783-175-05	1 in 1 CARTON	05/18/2015
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 46783-175-10	1 in 1 CARTON	05/18/2015
2		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 46783-175-15	1 in 1 CARTON	05/18/2015
3		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 46783-175-01	1 mL in 1 PACKET; Type 0: Not a Combination Product	05/18/2015
5	NDC: 46783-175-04	4 mL in 1 TUBE; Type 0: Not a Combination Product	05/18/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	05/18/2015

Labeler - Merz North America, Inc. (028147846)