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

Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 by

Drug Labeling and Warnings

Journee Bio-restorative Day Balm Broad-spectrum Suncreen 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.
• 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.

See package insert for complete information.

Directions

For sunscreen use:

• 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, Caprylic/Capric Triglyceride, Hydrogenated C6-14 Olefin Polymers, Hexyldecanol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Microcrystalline Cellulose, Camelia Sinensis Extract, Silica, Cutaneous Lysate, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Squalane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyhydroxystearic Acid, Steareth-21, Melanin, Cetearyl Alcohol, Sodium Hyaluronate, Polysorbate 60, Triethoxycaprylsilane, Disodium EDTA, Xanthan Gum, Cellulose Gum, Styrene/Acrylates Copolymer, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben.

Other information

• Protect this product from excessive heat and direct sun.

Questions?

1.844.469.6379

PRINCIPAL DISPLAY PANEL - 50 ML Bottle Carton

journée

REVITALIZING DAY CREAM
SPF 30

NEOCUTIS®

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46783-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	73 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HEXYLDECANOL (UNII: 151Z7P1317)
STEARETH-21 (UNII: 53J3F32P58)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
SQUALANE (UNII: GW89575KF9)
POLYSORBATE 60 (UNII: CAL22UVI4M)
HUMAN SKIN PROTEINS, PARTIALLY HYDROLYZED (UNII: G9813R29TW)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46783-002-01	1 in 1 CARTON	04/01/2011
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 46783-002-02	1 in 1 CARTON	04/01/2011
2		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 46783-002-03	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2011
4	NDC: 46783-002-05	4 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2011
5	NDC: 46783-002-50	1 in 1 CARTON	06/18/2019
5		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2011

Labeler - Merz North America, Inc. (028147846)