Otc - Active Ingredient
Active ingredients Purpose
Octinoxate 7.5% Sunscreen
Titanium Dioxide 5.02% Sunscreen
Sheer Defense Tinted Moisturizer Spf15 L20 Liquid
FDA Label NDC 57627-152
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 Sheer Defense Tinted Moisturizer Spf15 L20 (NDC 57627-152). 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 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 and evenly 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 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-sleeve shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor
Inactive Ingredient
Inactive ingredients:
Water (Aqua), Dimethicone, Butylene Glycol, Glyceryl Stearate SE, Mica, Talc, Iron Oxides, Glyceryl Dilaurate, Glyceryl Behenate, Ceramide 3, Saccharide Isomerate, Allantoin, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Glycine Soja (Soybean) Germ Extract, Echinacea Purpurea Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Equisetum Arvense Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Oleifera Leaf Extract, Lecithin, Petrolatum, Palmitic Acid, Polyglyceryl-10 Decaoleate, Polyacrylamide, PEG-12 Dimethicone, octyldodecyl Stearoyl Stearate, Steareth-20, C13-14 Isoparaffin, Isocetyl Alcohol, Propylene Glycol, Laureth-7, Silica, Cyclodextrin, Disodium EDTA, Phenoxyethanol, Tetrasodium EDTA, BHT, Diazolidinyl Urea, Fragrance(Parfum)
Package Label.Principal Display Panel
Carton (Carton)
Tube (Tube)
Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15
L20
Merle Norman
Established in Los Angeles since 1931
35 g Net wt. 1.25 Oz.
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