Otc - Active Ingredient
Avobenzone 3.0%
Octinoxate 7.5%
Octisalate 5.0%
Oxybenzone 5.0%
Cosmedix Spf50
FDA Label NDC 61531-103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Packaging Systems, Inc. Dba: Paklab for the product Cosmedix Spf50 (NDC 61531-103). 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, instructions for use, inactive ingredient, otc - questions, warnings, indications & usage, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Helps prevent sunburn
Instructions For Use
Apply liberally 15 minutes before sun exposure.
Inactive Ingredient
Water (Aqua), Propanediol, Dicaprylyl Carbonate, Carthamus Tinctorius (Safflower) Oleosomes, Cetyl Ethylhexanoate, Glycerin, Cetearyl Olivate, Squalane, Sorbitan Olivate, Silica, Trehalose, Trimethoxybenzylidene Pentanedione, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Butylene Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Tocopheryl Acetate, Ethylhexylglycerin, Citrus Grandis (Grapefruit) Peel Oil, Limonene, Potassium Sorbate, Polysorbate 60, Allantoin, Disodium EDTA, Titanium Dioxide (CI 77891), Caprylic/Capric Triglyceride, Sodium Hydroxide, Dimethyl Isosorbide, Carbomer, Moringa Pterygosperma Seed Extract, Boerhavia Diffusa Root Extract, Polysorbate 20, Sesamum Indicum (Sesame) Seed Extract, Urea, Glucosamine HCl, Algae Extract, Palmitoyl Oligopeptide, Tocopherol, Palmitoyl Tetrapeptide-7.
Otc - Questions
In the unlikely event of an adverse reaction, please contact 1-800-676-9522
Warnings
For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs.
Indications & Usage
Helps protect against sunburn.
Dosage & Administration
Topical emulsion
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