Otc - Active Ingredient
Octinoxate (6.5%)
Octisalate (4.0%)
Octocrylene (7.0%)
Oxybenzone (5.5%)
Sunscreen
FDA Label NDC 19392-400
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 19392-400). 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, warnings, otc - keep out of reach of children, 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 - Purpose
Sunscreen
Warnings
For external use only.
Avoid contact with eyes.
Discontinue use if rash or irritation occurs.
Children under 6 months consult a doctor before use.
Otc - Keep Out Of Reach Of Children
Children under 6 months consult a doctor before use.
Indications & Usage
For external use only.
Inactive Ingredient
Water, PPG-15 Stearyl Ether Benzoate, Corn Starch modified, Triethanolamine, Hypromellose, Acrylic Polymer, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium EDTA
Package Label.Principal Display Panel
1 Oz Sunscreen (Sunscreen)
* Please review the disclaimer below.
