MAYBELLINE NEW YORK FIT ME MATTE PLUS PORELESS MATTIFYING PORELESS PRIMER BROAD SPECTRUM SPF 20 SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene liquid 
L'Oreal USA Products Inc

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Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Purpose

Sunscreen

Uses

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, isononyl isononanoate, silica, copernicia cerifera (carnauba) wax, silica silylate, glycerin, octyldodecanol, PEG-30 dipolyhydroxystearate, triethanolamine, polyamide-8, phenoxyethanol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate, copolymer, octyldodecyl xyloside, caprylyl glycol, kaolin, disodium EDTA, sorbitan isostearate, polysorbate 60, linalool, benzyl salicylate, limonene, benzyl alcohol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, fragrance

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MAYBELLINE NEW YORK FIT ME MATTE PLUS PORELESS MATTIFYING PORELESS PRIMER BROAD SPECTRUM SPF 20 SUNSCREEN 
avobenzone, homosalate, octisalate, and octocrylene liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-443
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
TROLAMINE (UNII: 9O3K93S3TK)  
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
KAOLIN (UNII: 24H4NWX5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-443-0130 mL in 1 TUBE; Type 0: Not a Combination Product07/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02007/01/2022
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA Products Inc624244349manufacture(49967-443) , pack(49967-443)

Revised: 12/2023
Document Id: c2133e0c-dd0c-4fe3-9714-963de57ff0ce
Set id: c0c2aac2-1cd3-4e97-894c-a828fd9dba9b
Version: 2
Effective Time: 20231228
 
L'Oreal USA Products Inc