Otc - Active Ingredient
Avobenzone (2.0%)
Octinoxate (6.5%)
Octisalate (5.0%)
Octocrylene (1.5%)
Sunscreen
FDA Label NDC 19392-310
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 19392-310). 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, warnings, dosage & administration, other safety 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
Otc - Purpose
Sunscreen
Indications & Usage
Helps prevent sunburn
Inactive Ingredient
Mineral Oil, Beeswax, Petrolatum, Paraffin, Ethylhexyl Palmitate, Ceresin, Cetyl Alcohol, Toxopheryl Acetate, Propylparaben, Aloe Juice
Warnings
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 reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Apply liberally 15 min before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months of age: 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 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.
Other Safety Information
Protect this product from excessive heat and direct sun.
* Please review the disclaimer below.
