Drug Facts
Active ingredients Purpose
Titanium Dioxide 10.20% Sunscreen
Zinc Oxide 3.70% Sunscreen
Sfl Sunscreen - Sol Defense Cream
FDA Label NDC 59958-202
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Owen Biosciences Inc. for the product Sfl Sunscreen - Sol Defense (NDC 59958-202). 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 drug facts, main label image, otc - purpose, warnings, indications & usage, information for patients, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Main Label Image
Mainlabel.jpg (Mainlabel)
Otc - Purpose
USES
Helps protect against sunburn
Higher SPF gives more sunburn protection
Provides moderate protection against sunburn.
Warnings
Warnings
For external use only. When using this product keep
out of eyes. Rinse with water to remove. Stop use and
ask doctor if rash and irritation develops and lasts.
Avoid contact with eyes. If product gets into eyes,
rinse thoroughly with water.
Keep out of reach of children. If swallowed, get
medical help or contact poison control center right
away.
Indications & Usage
Directions
Apply generously before sun exposure and as
needed. For children under 6 months, ask a doctor.
Reapply as needed or after towel drying, swimming
or perspiring.
Information For Patients
Other Information
Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other
harmful effects of the sun.
Inactive Ingredient
Inactive Ingredients
Cyclopentasiloxane, Cyclomethicone, Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer,
Dimethicone/Vinyl Dimethicone Crosspolymer, Melanin, Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol,
Alumina, PEG-10 Dimethicone, Methicone, Iron Oxides.
* Please review the disclaimer below.
