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Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'OREAL USA PRODUCTS, INC.
Effective date
2024-01-30
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:12:08

Label at a glance#

ProductMaybelline Dream Urban Cover Full Coverage Protective Make-Up SPF 50 Antioxidant-Enriched Pollution Protection
Active ingredientHOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure13 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: ● 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: ● limi...

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

Homosalate 10%

Octisalate 5%

Octocrylene 4%

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.

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:

● 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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-322-2036

Monday - Friday (9 a.m. - 5 p.m. EST)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, dimethicone, propanediol, alcohol denat., niacinamide, vinyl dimethicone/methicone silsesquioxane crosspolymer, synthetic flourphlogopite, PEG-30 dipolyhydroxystearate, tocopherol, caffeine, disteardimonium hectorite, polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate, magnesium sulfate, phenoxyethanol, disodium stearoyl glutamate, scutellaria baicalensis root extract, aluminum hydroxide, fragrance, limonene, benzyl salicylate, citral; may contain: titanium dioxide, iron oxides

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-51849967-518-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
PROPANEDIOL5965N8W85TIACT
ALCOHOL3K9958V90MIACT
NIACINAMIDE25X51I8RD4IACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
TOCOPHEROLR0ZB2556P8IACT
CAFFEINE3G6A5W338EIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DISODIUM STEAROYL GLUTAMATE45ASM2L11MIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
BENZYL SALICYLATEWAO5MNK9TUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE RED1K09F3G675IACT

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
061c21f3-578a-4a7d-a25e-a2231df07d33869ac6ab-d38e-4f9b-85d9-876bfd3f6f5d2024-01-30WarningsExact identifier
spl id: 061c21f3-578a-4a7d-a25e-a2231df07d33
spl set id: 869ac6ab-d38e-4f9b-85d9-876bfd3f6f5d

Reported adverse events (FAERS/openFDA)#

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