Op Protective Gel 15
FDA Label NDC 62802-039

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sun & Skin Care Research, Llc for the product Op Protective Gel 15 (NDC 62802-039). 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 active ingredients, purpose, uses, warnings, directions, other information, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

  • Octinoxate 7.5%
  • Octisalate 5.0%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.Do not use on damaged or broken skin.  Stop use and ask a doctor if rash occurs.  When using this product keep out of eyes.  Rinse with water to remove.  Keep out of the reach of children.  If swallowed, get medical help or call a poison control center right away.

Directions

  • apply evenly and liberally to all exposed areas 15 minutes before sun exposure.  Ensure skin is completely covered with product.
  • reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours
  • children under 6 months:  Ask a doctor

Other Information

  • protect this product from excessive heat and direct sun
  • for use on skin only
  • avoid contact with fabric

Package Label.Principal Display Panel

Image Of Carton Label (00039)

Image Of Carton Label (00039)

* Please review the disclaimer below.