LE MIEUX NAKED GLOW BRONZER SPF 50- sunscreen gel

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENTS

Drug Facts

Active Ingredients ……………….….. Purpose

Avobenzone 3.0% ………………...... Sunscreen

Homosalate 8.0% …………….......… Sunscreen

Octisalate 5.0% ……………..........… Sunscreen

Octocrylene 4.0% …………….......... 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

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

INGREDIENTS AND APPEARANCE

LE MIEUX NAKED GLOW BRONZER SPF 50 
sunscreen gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81208-206
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
CI 77891 (UNII: 15FIX9V2JP)
TIN OXIDE (UNII: KM7N50LOS6)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
COPRINUS COMATUS FRUITING BODY (UNII: 62ZVN02QZG)
GRIFOLA FRONDOSA WHOLE (UNII: O238UC53ET)
ISOHEXADECANE (UNII: 918X1OUF1E)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
ISODODECANE (UNII: A8289P68Y2)
C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
ACETYL HEXAPEPTIDE-1 (UNII: 49ZWR266MZ)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
GANODERMA LUCIDUM WHOLE (UNII: J5P04QW0CF)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)
CI 77491 (UNII: 1K09F3G675)
DIMETHICONE CROSSPOLYMER (180000 MPA.S) (UNII: W8CS8KBY2B)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
OPHIOCORDYCEPS SINENSIS (UNII: 8Q1GYP08KU)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
POLYGLUTAMIC ACID (1200 MW) (UNII: MGE3733FR2)
TERMINALIA CHEBULA FRUIT (UNII: S8R4V700NK)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MEADOWFOAM ESTOLIDE (UNII: 3HH93SL2H9)
RHODODENDRON FERRUGINEUM WHOLE (UNII: FO6B1S7BZU)
SORBITAN LAURATE (UNII: 6W9PS8B71J)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)

Product Characteristics
Color	brown (Bronze to Brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81208-206-02	1 in 1 CARTON	04/30/2025
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/30/2025

Labeler - YB CHEMIA LLC (095778265)