Otc - Active Ingredient
Active Ingredients
Octinoxate 7.50%
Oxybenzone 3.00%
Flawless Effect Liquid Foundation Spf 15 Liquid
FDA Label NDC 57627-113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Merle Norman Cosmetics, Inc for the product Flawless Effect Liquid Foundation Spf 15 (NDC 57627-113). 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.
Label Section Quick Index
Otc - Purpose
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings
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.
Dosage & Administration
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 skin
cancer and early skin aging. To decrease this risk, regularly use a sunscreen
with broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
· Children under 6 months: Ask a doctor
Inactive Ingredient
Water(aqua), cyclopentasiloxane , mica, titanium dioxide, diisostearyl malate, ethylhexyl palmitate, glycerin, pentylene glycol, peg-30 dipolyhydroxystearate, iron oxides, propylene glycol, cyclohexasiloxane, aluminum starch octenylsuccinate, disteardimonium hectorite, hdi/ppg/polycaprolactone crosspolymer, glyceryl oleate, glyceryl stearate, myristyl myristate, polyglyceryl-3 beeswax, lecithin, disodium stearoyl glutamate, Butylene Glycol, sodium hyaluronate, camellia oleifera leaf extract, ginkgo biloba leaf extract, chamomilla recutita (matricaria) flower extract, tetrahexyldecyl ascorbate, tocopheryl acetate, aluminum hydroxide (Cl 77002), silica, alcohol denat., BHT, phenoxyethanol, methylparaben, propylparaben
Package Label.Principal Display Panel
Flawless Effect Liquid Foundation SPF 15
Merle Norman
30 mL 1 FL. OZ.
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