Maybelline New York Fit Me Foundation Dewy Plus Smooth SPF 18 Sunscreen

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc.
Effective date
2023-12-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:53

Label at a glance#

ProductMaybelline New York Fit Me Foundation Dewy Plus Smooth SPF 18 Sunscreen
Active ingredientOCTINOXATE
Label structure14 sections

Dosage and administration

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 ● children under 6 months of age: Ask a doctor

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

Octinoxate 7%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Skin Cancer/Skin Aging Alert:

USER SAFETY WARNINGS SECTION

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● 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, cyclopentasiloxane, dimethicone, glycerin, isotridecyl isononanoate, PEG-9 polydimethylsiloxyethyl dimethicone, disteardimonium hectorite, dimethicone/polyglycerin-3 crosspolymner, sodium chloride, PEG-10 dimethicone, phenoxyethanol, methylparaben, disodium stearoyl glutamate chlorphenesin, disodium, EDTA, acrylates copolymer, propylparaben, fragrance, tocopherol ascorbyl palmitate, aluminum hydroxide, butylparaben PEG-9, ethylparaben, dipropylene glycol, alphaisomethyl ionone; may contain: titanium dioxide, iron oxides

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-969-01Maybelline New York Fit Me Foundation Dewy Plus Smooth SPF 18 Sunscreen30 mL in 1 BOTTLE, GLASSLOTION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-969MAYBELLINE NEW YORK FIT ME FOUNDATION DEWY PLUS SMOOTH SPF 18 SUNSCREEN (OCTINOXATE) LOTION [L'OREAL USA PRODUCTS INC]3Current NDC, Legacy NDC, 1 package rows20231229_52e169b7-3560-489e-b7ab-1fea01466c0c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTINOXATEACTIVE MOIETY4Y5P7MUD511

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-96949967-969-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT

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 Foundation Dewy Plus Smooth SPF 18 SunscreenOCTINOXATEL'Oreal USA Products Inc52e169b7-3560-489e-b7ab-1fea01466c0c2023-12-28WarningsExact identifier
ndc (package): 49967-969-01
ndc (product): 49967-969
ndc11 (package): 49967096901
spl id: 8ec56f5f-3741-475d-9c6d-8b68224b56bb
spl set id: 52e169b7-3560-489e-b7ab-1fea01466c0c

Reported adverse events (FAERS/openFDA)#

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