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
Drug Facts
- Manufacturer
- L'Oreal USA Products Inc | L'OREAL USA PRODUCTS, INC
- Effective date
- 2024-06-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:18:27
Label at a glance#
ProductLOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 Sunscreen
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure15 sections
Dosage and administration
For sunscreen use: shake well beore using apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscren 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 incl...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients
Octinoxate 6.7%
Titanium dioxide 4.6%
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, flames 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 beore using
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscren 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, HDI/trimethylol hexyllactone crosspolymer, disteardimonium hectorite, BIS -PEG/PPG-14/14 dimethicone, magnesium sulfate, aluminum hydroxide, phenoxyethanol, disodium stearoyl glutamate, hydrogen dimethicone, cellulose, dipentaerythrityl tetrahydroxystearate/tetraisostearate, ascorbyl glucoside, silica silylate, fragrance, calcium aluminum borosilicate, tocopherol, silica, hexyl cinnamal, benzyl salicylate, BHT, linalool, alpha-isomethyl ionone, benzyl alcohol, citronellol; may contain: titanium dioxide, iron oxides, bismuth oxychloride, mica
Questions or comments?
1-800-322-2036
Monday - Friday
(10 a.m. - 5 p.m. EST)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49967-815-01 | LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 Sunscreen | 30 mL in 1 BOTTLE | LIQUID | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49967-815 | LOREAL PARIS INFALLIBLE UP TO 32H FRESH WEAR FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [L'OREAL USA PRODUCTS INC] | 1 | Current NDC, 1 package rows | 20240901_f6457973-3718-44cd-a764-de0b089d4eee.zip |
Products#
Every source-derived product name is available through these pages.
- LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 Sunscreen
- Octinoxate and Titanium Dioxide
- OCTINOXATE
- TITANIUM DIOXIDE
- WATER
- DIMETHICONE
- ISODODECANE
- ALCOHOL
- BUTYLENE GLYCOL
- PERLITE
- NYLON-12
- ISOPROPYL LAUROYL SARCOSINATE
- DIISOPROPYL SEBACATE
- HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER
- DISTEARDIMONIUM HECTORITE
- BIS-PEG/PPG-14/14 DIMETHICONE
- MAGNESIUM SULFATE, UNSPECIFIED FORM
- ALUMINUM HYDROXIDE
- PHENOXYETHANOL
- DISODIUM STEAROYL GLUTAMATE
- POWDERED CELLULOSE
- DIPENTAERYTHRITYL TETRAHYDROXYSTEARATE/TETRAISOSTEARATE
- ASCORBYL GLUCOSIDE
- CALCIUM ALUMINUM BOROSILICATE
- TOCOPHEROL
- SILICON DIOXIDE
- .ALPHA.-HEXYLCINNAMALDEHYDE
- BENZYL SALICYLATE
- BUTYLATED HYDROXYTOLUENE
- LINALOOL, (+/-)-
- ISOMETHYL-.ALPHA.-IONONE
- BENZYL ALCOHOL
- .BETA.-CITRONELLOL, (R)-
- FERRIC OXIDE RED
- BISMUTH OXYCHLORIDE
- MICA
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49967-815 | 49967-815-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 Sunscreen | OCTINOXATE AND TITANIUM DIOXIDE | L'Oreal USA Products Inc | f6457973-3718-44cd-a764-de0b089d4eee | 2024-06-28 | Warnings | 49967-815-01 49967-815 49967081501 df6a157b-4b48-4e3a-a4ca-a3e1e547d006 f6457973-3718-44cd-a764-de0b089d4eee |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.