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.

Directions

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

Inactive Ingredients

Water, Caprylic / Capric Triglyceride, Hydrogenated Poly (C6-14 Olefin), Hexyldecanol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Microcrystalline Cellulose, Camellia Sinensis Leaf 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, Triethoxycaprylysilane, Disodium EDTA, Xanthan 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.
Raleigh, NC 27615

PRINCIPAL DISPLAY PANEL - 200 ML Bottle Label

FOR PROFESSIONAL USE ONLY.
NOT FOR RESALE.

journée

REVITALIZING DAY CREAM
BROAD SPECTRUM
SPF 30

NEOCUTIS®

PRINCIPAL DISPLAY PANEL - 200 ML Bottle Label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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	05/31/2024
5		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - Merz North America, Inc. (028147846)

Journée Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30