Linea Jose Ignacio Sunscreen Broad Spectrum Spf30
FDA Label NDC 69096-0100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Linea Jose Ignacio for the product Linea Jose Ignacio Sunscreen Broad Spectrum Spf30 (NDC 69096-0100). 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, warnings, otc - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Dist. by:
Linea Jose Ignacio
53 East 34th Street
Paterson, NJ 07514
www.lineajoseignacio.com

Active Ingredients

Avobenzone 1.5%
Octinoxate 7.5%
Octisalate 5.0%
Oxybenzone 6.0%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • 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

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - When Using

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

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.

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • children under 6 months: Ask a doctor
    • 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 of 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

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Cetyl Phosphate, Ethylhexyl Glycerin, Glycerin, Glyceryl Stearate, Green Tea Extract, Magnesium Ascorbyl Phosphate, Methyl Gluceth-20, Mixed Tocopherols, Octyl Palmitate, Panthenol, Phenoxyethanol, PVP Eicosene Copolymer, Stearic Acid, Tocopheral Acetate, Water

Other Information

  • protect this product from excessive heat and direct sun

Questions?

Visit www.lineajoseignacio.com

Principal Display Panel - 150 Ml Tube Label

LINEA
JOSE
IGNACIO™

SUNSCREEN

BROAD SPECTRUM
SPF 30

WATER RESISTANT
80 MINUTES

Net Wt. 5 FL OZ (150 mL)

Principal Display Panel (150 mL Tube Label)

Principal Display Panel (150 mL Tube Label)

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