Drug Facts
Active ingredients Purpose
Titanium Dioxide 10.20% Sunscreen
Zinc Oxide 3.70% Sunscreen
Dermaroller Anhydrous Sunscreen Cream
FDA Label NDC 59958-201
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 Dermaroller Anhydrous Sunscreen (NDC 59958-201). 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, information for patients, 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
USES
Helps Prevent 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. Keep out of reach of
children. If swallowed, get medical help or
contact poison control center right away.
Indications & Usage
Directions
Apply evenly before sun exposure and as
needed. For children under 6 months of age: 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.
Package Label.Principal Display Panel
Main Label (Mainlabel1)
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