NYX PROFESSIONAL MAKEUP BLURSCREEN PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion

NYX Professional Makeup Blurscreen Primer Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

NYX Professional Makeup Blurscreen Primer Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Accupac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 7.3%

Octisalate 5%

Octocrylene 10%

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:

●  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:

     ● limit time in the sun, especially from 10 a.m. – 2 p.m.

     ● 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, isododecane, silica, butyloctyl salicylate, c12-15 alkyl benzoate, copernicia cerifera (carnauba) wax, niacinamide, glycerin, octyldodecanol, PEG-30 dipolyhydroxystearate, silica silylate, polyamide-8, phenoxyethanol, diethylhexyl syringylidenemalonate, octyldodecyl xyloside, hydroxyacetophenone, caprylyl glycol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, trisodium ethylenediamine disuccinate, caprylic/capric triglyceride, cocos nucifera (coconut) fruit juice, fragrance, sorbitan isostearate, polysorbate 60, citric acid, sodium hyaluronate, hydrolyzed opuntia ficus-indica flower extract, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, sodium benzoate, ethylhexylglycerin, potassium sorbate

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NYX PROFESSIONAL MAKEUP BLURSCREEN PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-990
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	73 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT JUICE (UNII: AMN6S4M09G)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-990-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2024
2	NDC: 49967-990-02	2 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2024

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, LLC		061595175	manufacture(49967-990) , pack(49967-990)