Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc.
Effective date
2023-12-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:59

Label at a glance#

ProductLOreal Paris Infallible Up to 24 H Fresh Wear Foundation Broad Spectrum SPF 25 Sunscreen
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure15 sections

Indications and 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

Dosage and administration

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 inclu...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 6.7%

Titanium dioxide 3.6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

- 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

WARNINGS SECTION

For external use only

Flammable until dry.

SAFE HANDLING WARNING SECTION

Do not use near fire, flame or heat.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

 keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-322-2036

Monday - Friday

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of front labelimage of front label

image of front label
image of front label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of back labelimage of back label

image of back label
image of back label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-009-01LOreal Paris Infallible Up to 24 H Fresh Wear Foundation Broad Spectrum SPF 25 Sunscreen30 mL in 1 BOTTLELIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-009LOREAL PARIS INFALLIBLE UP TO 24 H FRESH WEAR FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [L'OREAL USA PRODUCTS INC]3Current NDC, Legacy NDC, 1 package rows20231230_917f6775-8f48-4b7e-9f67-253bc0c6d59e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-00949967-009-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOreal Paris Infallible Up to 24 H Fresh Wear Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc917f6775-8f48-4b7e-9f67-253bc0c6d59e2023-12-29WarningsExact identifier
ndc (package): 49967-009-01
ndc (product): 49967-009
ndc11 (package): 49967000901
spl id: 85bcc58e-e4f7-48a9-9d4d-51449f87c88c
spl set id: 917f6775-8f48-4b7e-9f67-253bc0c6d59e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.