Active Ingredients
Drug Facts
Active Ingredients ……………….….. Purpose
Avobenzone 3.0% ………………...... Sunscreen
Homosalate 8.0% …………….......… Sunscreen
Octisalate 5.0% ……………..........… Sunscreen
Octocrylene 4.0% …………….......... Sunscreen
Le Mieux Naked Glow Bronzer Spf 50 Gel
FDA Label NDC 81208-206
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yb Chemia Llc for the product Le Mieux Naked Glow Bronzer Spf 50 (NDC 81208-206). 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 active ingredients, uses, warnings, keep out of reach, directions, other information, inactive ingredients, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Warnings
For external use only
Do not use on damaged or broken skin
Stop use and ask a doctor if rash occurs
When using this product keep out of eyes. Rinse with water to remove.
Keep Out Of Reach
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply liberally 15 minutes before sun exposure
Rub in well.
Reapply at least every 2 hours
Children under 6 months: Ask a doctor
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10 a.m. to 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses.
Other Information
Protect the product in this container from excessive heat and direct sunlight
Inactive Ingredients
Acetyl Hexapeptide-1, C12-15 Alkyl Benzoate, C18-36 Acid Glycol Ester, C18-36 Acid Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Capryloyl Glycine, Caprylyl Glycol, Coprinus Comatus (Mushroom) Extract, Cordyceps Sinensis Extract, Dicaprylyl Carbonate, Dimethicone Crosspolymer-3, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Ganoderma Lucidum (Reishi Mushroom) Extract, Glycerin, Grifola Frondosa (Mushroom) Extract, Isododecane, Isohexadecane, Isopropyl Palmitate, Lecithin, Meadowfoam Estolide, Neopentyl Glycol Diheptanoate, Octyldodecyl Neopentanoate, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Polyglutamic Acid, Polymethylsilsesquioxane, Rhododendron Ferrugineum Extract, Sorbitan Laurate, Terminalia Chebula (Haritaki) Fruit Extract, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Undecylenoyl Glycine, Water.
May contain: Calcium Sodium Borosilicate, Iron Oxides, Mica, Synthetic Fluorphlogopite and Titanium Dioxide.
Indications & Usage
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.
Principal Display Panel
Unit Carton (Nakedglowbronzer Box V1 1)
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