LOREAL PARIS INFALLIBLE UP TO 24 H FRESH WEAR FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN- octinoxate and titanium dioxide liquid 
L'Oreal USA Products Inc

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Drug Facts

Active ingredients

Octinoxate 6.7%

Titanium dioxide 3.6%

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

Flammable until dry.

Do not use near fire, flame or heat.

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

● 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, dimethicone, isododecane, alcohol denat., trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, perlite, synthetic fluorphlogopite, nylon-12, isopropyl lauroyl sarcosinate, diisopropyl sebacate, disteardimonium hectorite, HDI/trimethylol hexyllactone crosspolymer, bis-PEG/PPG-14/14 dimethicone, magnesium sulfate, aluminum hydroxide, phenoxyethanol, disodium stearoyl glutamate, hydrogen dimethicone, dipentaerythrityl tetrahydroxystearate/tetraisostearate, fragrance, silica silylate, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, tocopherol, hexyl cinnamal, silica, isobutane, benzyl salicylate, linalool, alpha-isomethyl ionone, benzyl alcohol, BHT, citronellol, may contain: titanium dioxide, iron oxides, ferric ammonium ferrocyanide

Questions or comments?

1-800-322-2036

Monday - Friday

(10 a.m. - 5 p.m. EST)

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LOREAL PARIS INFALLIBLE UP TO 24 H FRESH WEAR FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN 
octinoxate and titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE67 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE36 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
ALCOHOL (UNII: 3K9958V90M)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PERLITE (UNII: 0SG101ZGK9)  
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
NYLON-12 (UNII: 446U8J075B)  
ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
DIPENTAERYTHRITYL TETRAHYDROXYSTEARATE/TETRAISOSTEARATE (UNII: 230K0823CE)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ISOBUTANE (UNII: BXR49TP611)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC AMMONIUM FERROCYANIDE (UNII: 9R0NVI936I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-009-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/01/2018
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.624244349manufacture(49967-009)

Revised: 12/2023
Document Id: 85bcc58e-e4f7-48a9-9d4d-51449f87c88c
Set id: 917f6775-8f48-4b7e-9f67-253bc0c6d59e
Version: 3
Effective Time: 20231229
 
L'Oreal USA Products Inc