Otc - Active Ingredient
Active Ingredients Purpose
Avobenzone 1.9% Sunscreen
Octocrylene 9.4% Sunscreen
The following Structured Product Label (SPL) was submitted to the FDA by Merle Norman Cosmetics, Inc for the product Preventage Firming Defense Creme Normal/dry (NDC 57627-121). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients Purpose
Avobenzone 1.9% Sunscreen
Octocrylene 9.4% Sunscreen
Uses
-Helps prevent sunburn.
-If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a doctor if rash occurs.
Warnings For external use only.
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Directions For sunscreen use:
-Apply liberally 15 minutes before sun exposure.
-Use a water resistant sunscreen if swimming or sweating.
-Reapply at least every 2 hours.
Sun Protection Measures. Spending time in the sun increases your risk of sin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
-Limit time in the sun, especially from 10 a.m. – 2 p.m.
-Wear long-sleeved shirts, pants, hats, and sunglasses.
Children under 6 months: Ask a doctor.
Inactive Ingredients: Water (Aqua), Glycerin, Butyloctyl Salicylate, Diethylhexyl Maleate, Jojoba Esters, Cyclopentasiloxane, C10-30 Cholesterol/Lanosterol Esters, Phenyl Trimethicone, Stearic Acid, Stearyl Alcohol, GlycerylPolymethacrylate, Propylene Glycol, Biosaccharide Gum-1, Sorbitan Stearate, PalmitoylOligopeptide, DipalmitoylHydroxylproline, Hydrolyzed Elastin, Collagen Amino Acids, Hydrolyzed Malt Extract, Hydrolyzed Rice Protein, Ilex Aquifolium (Holly) Leaf Extract, Calluna Vulgaris Flower Extract, CucumisSativus (Cucumber) Fruit Extract, Ginkgo Biloba Leaf Extract, RuscusAculeatus Root Extract, Echinacea Angustifolia Extract, Camellia Sinensis Leaf Extract, Glycyrrhetinic Acid, HamamelisVirginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hyaluronic Acid, EuphrasiaOfficinalis Extract, Bisabolol, Tocopheryl Acetate, AscorbylPalmitate, RetinylPalmitate, Lecithin, Dimethicone, Dimethicone/Vinyl DimethiconeCrosspolymer, CetearylMethicone, Bis-EthylhexylHydroxydimethoxyBenzylmalonate, PPG-20 Methyl Glucose Ether, PEG-100 Stearate, Polysorbate 60, Sorbitol, Triethanolamine, Alcohol, Caprylyl Glycol, Butylene Glycol, Polyquaternium-24, Sodium Oleanolate, Sodium Ursolate, Phospholipids, PEG-7M, PEG-8, Carbomer, Silica, PVP, Phenoxyethanol, Chlorphenesin, Methylisothiazolinone, Diazolidinyl Urea, Imidazolidinyl Urea, Methylparaben, Disodium EDTA, Trisodium EDTA, Yellow 5, Red 4
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