JOURNEE Bio-restorative Day Cream Broad Spectrum Sunscreen SPF 30

JOURNEE by

Drug Labeling and Warnings

JOURNEE by is a Otc medication manufactured, distributed, or labeled by Neocutis, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

JOURNEE- octinoxate, zinc oxide cream 
Neocutis, 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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JOURNEE Bio-restorative Day Cream Broad Spectrum Sunscreen SPF 30

JOURNEE Bio-restorative Day Cream 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.
  • Higher SPF give 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally and evenly 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 a broad spectrum SPF 15 or higher and other sun protection measures including:



  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses
  • Children under 6 months of age: ask a doctor.

Other information



  • Protect this product from excessive heat and direct sun.

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, Styrene/Acrylates Copolymer, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben.

JOURNEE is the only day cream that combines PSP technology with anti-oxidants and broad-spectrum sun protection. Elegantly formulated JOURNEE helps revitalize the skin while guarding against premature skin aging.

Years of research enabled the bio-engineering of Processed Skin Proteins (PSP). PSP is a naturally balanced mixture of essential skin nutrients that nourish and revitalize the skin's outer layer. This clinically proven ingredient beautifully helps rejuvenate the appearance of aged and stressed skin.

The light, non-greasy formulation is fast absorbing and fragrance free. Green tea extract combined with melanin and stabilized vitamins C and E provide anti-oxidant protection.

JOURNEE is ideal for daily use and can be used on problematic or post-procedural skin if skin is not damaged or broken.

All Skin Types.


  • Non-comedogenic.
  • Free of fragrances and synthetic color additives.
  • Dermatologist tested.
  • Not tested on Animals.

Manufactured in the USA for:
Neocutis Inc.
3053 Fillmore Street 140
San Francisco, CA 94123
www.NEOCUTIS.com



Questions or comments?

Call toll free: 1-866-636-2884
9 AM - 5 PM EST Monday - Friday


JOURNEE Bio-restorative Day Cream Broad Spectrum Sunscreen SPF 30

JOURNEE

NEO

SWISS TECHNOLOGY

NEOCUTIS

JOURNEEInnerPackage

JOURNEEOuterPackage



JOURNEE 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52318-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE73 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HEXYLDECANOL (UNII: 151Z7P1317)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SQUALANE (UNII: GW89575KF9)  
STEARETH-21 (UNII: 53J3F32P58)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STYRENE (UNII: 44LJ2U959V)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52318-002-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/201706/15/2019
2NDC: 52318-002-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/201706/15/2019
3NDC: 52318-002-03200 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/201706/15/2019
4NDC: 52318-002-0450 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/201706/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/19/201706/15/2019
Labeler - Neocutis, Inc. (196482108)

Revised: 6/2019
 
Neocutis, Inc.