Sunscreen
FDA Label NDC 19392-300

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Humphreyline for the product Sunscreen (NDC 19392-300). 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 otc - active ingredient, otc - purpose, indications & usage, inactive ingredient, 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

Otc - Active Ingredient

Octinoxate (7.5%)

Oxybenzone (4%)

Otc - Purpose

Sunscreen

Indications & Usage

Helps prevent sunburn and chapped lips

Inactive Ingredient

Petrolatum, Octyl Palmitate, Beeswax, Paraffin, Mineral Oil, Ceresin, Cetyl Alcohol, Fragrance, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate (Vitamin E), Propylparaben

Package Label.Principal Display Panel

Lip Balm (Lipbalm2)

Lip Balm (Lipbalm2)

* Please review the disclaimer below.