Journee Bio-restorative Day Balm Broad-spectrum Suncreen Spf 30 Lotion
FDA Label NDC 46783-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Merz North America, Inc. for the product Journee Bio-restorative Day Balm Broad-spectrum Suncreen Spf 30 (NDC 46783-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

For external use only.

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.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

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

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BIO•ESSENTIALS

JOURNÉE
Bio-restorative Day Cream
Broad-spectrum Sunscreen SPF 30

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1.69 FL. OZ. (50 ML)

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Principal Display Panel (50 ML Bottle Carton)

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