JOURNEE

Dosage form: cream
Ingredients: OCTINOXATE 75mg in 1mL, ZINC OXIDE 73mg in 1mL
Labeler: Neocutis, Inc.
NDC Code: 52318-002

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.

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





JOURNEE  
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52318-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE73 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
MEDIUM-CHAIN TRIGLYCERIDES 
HEXYLDECANOL 
GLYCERIN 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
POTASSIUM CETYL PHOSPHATE 
HYDROGENATED PALM GLYCERIDES 
CELLULOSE, MICROCRYSTALLINE 
GREEN TEA LEAF 
SILICON DIOXIDE 
SODIUM ASCORBYL PHOSPHATE 
ALPHA-TOCOPHEROL ACETATE 
SQUALANE 
STEARETH-21 
CETOSTEARYL ALCOHOL 
HYALURONATE SODIUM 
POLYSORBATE 60 
TRIETHOXYCAPRYLYLSILANE 
EDETATE DISODIUM 
XANTHAN GUM 
STYRENE 
PHENOXYETHANOL 
METHYLPARABEN 
ETHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:52318-002-0230 mL in 1 BOTTLE
2NDC:52318-002-0115 mL in 1 BOTTLE
3NDC:52318-002-03200 mL in 1 BOTTLE
4NDC:52318-002-0450 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/18/2012
Labeler - Neocutis, Inc. (196482108)
Establishment
NameAddressID/FEIOperations
Englewood Lab, LLC172198223manufacture(52318-002)

Revised: 06/2013
 
Neocutis, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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