Otc - Active Ingredient
Active Ingredients Purpose
Octinoxate 4.0% Sunscreen
Titanium Dioxide 5.2% Sunscreen
Bare Expert Finish Makeup Broad Spectrum Spf 25 Cream
FDA Label NDC 57627-157
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 Bare Expert Finish Makeup Broad Spectrum Spf 25 (NDC 57627-157). 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
Isononyl Isononanoate, Ethylhexyl Palmitate, Polyethylene, Nylon-12, C12-15 Alkyl Benzoate, Lauroyl Lysine, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Talc, Isostearyl Neopentanoate, Astrocaryum Murumuru Seed Butter, Cetyl Dimethicone, Silica, Aluminum Starch Octenylsuccinate, Copernicia Cerifera (Carnauba) Wax, Dimethicone, Tocopheryl Acetate, Polyhydroxystearic Acid, Stearic Acid, Polyurethane-40, Sorbitan Oleate, Sorbitan Laurate, Myristyl Malate Phosphonic Acid, BHT Aluminum Oxide, May Contain, Iron Oxides, Titanium Dioxide
Package Label.Principal Display Panel
Expert Finish Makeup Broad Spectrum SPF 25
Merle Norman
17 g Net Wt. .60 Oz
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