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Drug Facts

Manufacturer
L’Oreal USA Products Inc | L'OREAL USA PRODUCTS, INC.
Effective date
2026-06-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-15 00:33:06

Label at a glance#

ProductMAYBELLINE NEW YORK FIT ME DEWY PLUS SMOOTH FOUNDATION SPF 18 SUNSCREEN
Active ingredientOCTISALATE
Label structure13 sections

Indications and uses

helps prevent sunburn

Dosage and administration

For sunscreen use: ● apply 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: ●...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octisalate 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

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:

● apply 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, glycerin, isododecane, isotridecyl isononanoate, propanediol, butyloctyl salicylate, PEG-10 dimethicone, PEG-9 polydimethylsiloxyethyl dimethicone, niacinamide, trimethylsiloxysilicate, synthetic fluorphlogopite, phenoxyethanol, dimethicone/polyglycerin-3 crosspolymer, disteardimonium hectorite, sodium chloride, disodium stearoyl glutamate, chlorphenesin, tocopherol, trisodium ethylenediamine disuccinate, ethylhexylglycerin, aluminum hydroxide, maltodextrin, citric acid, sodium hyaluronate, ascorbyl glucoside, dipropylene glycol, alpha-isomethyl ionone, camellia sinensis leaf extract; may contain: titanium dioxide, iron oxides

Questions or comments?

OTC - QUESTIONS SECTION

1-800-322-2036

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30ml 130ml 130ml 230ml 2

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82046-34582046-345-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
ISODODECANEA8289P68Y2IACT
ISOTRIDECYL ISONONANOATEWEF51750MTIACT
PROPANEDIOL5965N8W85TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PEG-10 DIMETHICONE (200 CST)287GF3Y3WCIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
NIACINAMIDE25X51I8RD4IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEYK3DC63Y5MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER2P2G24V6T9IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SODIUM CHLORIDE451W47IQ8XIACT
DISODIUM STEAROYL GLUTAMATE45ASM2L11MIACT
CHLORPHENESINI670DAL4SZIACT
TOCOPHEROLR0ZB2556P8IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
MALTODEXTRIN7CVR7L4A2DIACT
CITRIC ACID2968PHW8QPIACT
SODIUM HYALURONATEYSE9PPT4THIACT
ASCORBYL GLUCOSIDE2V52R0NHXWIACT
DIPROPYLENE GLYCOLE107L85C40IACT
ALPHA-ISOMETHYL IONONE9XP4LC555BIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
OCTISALATE4X49Y0596WACTIB

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
MAYBELLINE NEW YORK FIT ME DEWY PLUS SMOOTH FOUNDATION SPF 18 SUNSCREENOCTISALATELOreal USA Products Inc3b99ab06-ba4c-4ddd-a057-60028eedd67d2026-06-16WarningsExact identifier
ndc (package): 82046-345-01
ndc (product): 82046-345
ndc11 (package): 82046034501
spl id: 54603763-e962-7aa4-e063-6294a90a5db2
spl set id: 3b99ab06-ba4c-4ddd-a057-60028eedd67d

Reported adverse events (FAERS/openFDA)#

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