Sente Daily Repair Complex
FDA Label NDC 59958-220

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 Sente Daily Repair Complex (NDC 59958-220). 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, otc - purpose, warnings, 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.

Drug Facts

Active ingredients                  Purpose

(Zinc Oxide) 3.72%                 Sunscreen

(Titanium Dioxide) 9.95%        Sunscreen

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 evenly to skin before exposure to sun and as needed.

Reapply as needed or after towel drying or swimming.

For children under 6 months, ask a doctor.

Inactive Ingredient

Inactive Ingredients

Cyclopentasiloxane, Cyclo-methicone, Water (Aqua), Dimethicone/Vinyl Dimethicone Cross-polymer, Melanin, Tribehenin, Methyl Methacrylate/Glycol, Calcium Behenate, Sorbitan Isostearate, Dimethiconol, Heparan Sulfate, Alumina, PEG-10 Dimethicone, Silybin, Ascobyl Linoleate, Lysophosphatidic Acid, Plankton Extract, Methicone, hydrogen Dimethicone, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, CI 77492 (Iron Oxide), Polyaminopropyl Biguanide

Package Label.Principal Display Panel

Image Description (Box1)

Image Description (Box1)

* Please review the disclaimer below.