NYX PROFESSIONAL MAKEUP BUTTERMELT GLAZE SOFT GLOW SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30- homosalate,octisalate and octocrylene cream

NYX Professional Makeup Buttermelt Glaze SOFT GLOW SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

NYX Professional Makeup Buttermelt Glaze SOFT GLOW SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 by is a Otc medication manufactured, distributed, or labeled by L’Oreal USA Products Inc, Beauty Manufacturing Solutions Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Homosalate 7.3%

Octisalate 5%

Octocrylene 6%

Purpose

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

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• shake well before use
• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating.
• 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:

      o limit time in the sun, especially from 10am - 2pm

      o wear long-sleeved shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor

Other information

• protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, glycerin, caprylyl methicone, dimethicone, silica, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, niacinamide, propanediol, dimethicone/PEG-10/15 crosspolymer, camellia sinensis leaf extract, mangifera indica (mango) seed butter, butyrospermum parkii (shea) butter, simethicone, sodium chloride, sodium citrate, sodium hyaluronate, silica silylate, trimethylsiloxysilicate, aluminum hydroxide, adenosine, disodium stearoyl glutamate, dipropylene glycol, caprylyl glycol, citric acid, trisodium ethylenediamine disuccinate, maltodextrin, synthetic fluorphlogopite, disteardimonium hectorite, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, chlorphenesin, fragrance, limonene; may contain: titanium dioxide, iron oxides

Questions or comments?

1-844-335-3510

Monday-Friday

9 a.m.-5 p.m. EST

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NYX PROFESSIONAL MAKEUP BUTTERMELT GLAZE SOFT GLOW SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 
homosalate,octisalate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-356
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	73 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICA (UNII: ETJ7Z6XBU4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NIACINAMIDE (UNII: 25X51I8RD4)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
MANGIFERA INDICA (MANGO) SEED BUTTER (UNII: 4OXD9M35X2)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ADENOSINE (UNII: K72T3FS567)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID (UNII: 2968PHW8QP)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE (UNII: 255PIF62MS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
IRON OXIDES (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-356-01	1 in 1 CARTON	01/10/2024
1		30 mL 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	01/10/2024

Labeler - L’Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Beauty Manufacturing Solutions Corp.		783200723	manufacture(49967-356)