FDA.reportPublic FDA data

Maybelline Dream Pure BB Beauty Balm

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc.
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:48:26

Label at a glance#

ProductMaybelline Dream Pure BB Beauty Balm
Active ingredientSalicylic acid
Label structure11 sections

Indications and uses

- for the treatment of acne - helps clear up acne blemishes and allows skin to heal

Dosage and administration

- clean the skin thoroughly before apply this product - cover the entire affected area with a thin layer one to three times daily - because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor - if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 2%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

- for the treatment of acne

- helps clear up acne blemishes and allows skin to heal

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical can medication at a time.

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

- clean the skin thoroughly before apply this product

- cover the entire affected area with a thin layer one to three times daily

- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor

- if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, dimethicone, isododecane, glycerin, diisostearyl malate, kaolin, disteardimonium hectorite, PEG-9 polydimethylsiloxyethyl dimethicone, sodium chloride, phenoxyethanol, dimethicone/polyglycerin-3 crosspolymer, PEG-10 dimethicone, sodium hydroxide, disodium stearoyl glutamate, sodium dehydroacetate, silica silylate, chlorphenesin, perlite, acrylates copolymer, tocopherol, ascorbyl palmitate, aluminum hydroxide, PEG-9, dipropylene glycol; may contain: titanium dioxide, iron oxides

Questions or comments?

OTC - QUESTIONS SECTION

1-800-944-0730

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a labelimage of a label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a labelimage of a label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1539808MAYBELLINE DREAM PURE BB 2 % Topical LotionPSN5
103568salicylic acid 2 % Topical LotionPSN5
1539808salicylic acid 20 MG/ML Topical Lotion [Dream Pure BB]SBD5
103568salicylic acid 20 MG/ML Topical LotionSCD5
1539808Dream Pure BB 2 % Topical LotionSY5
103568salicylic acid 2 % Topical LotionSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-957-01Maybelline Dream Pure BB Beauty Balm30 mL in 1 TUBELOTION305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-957MAYBELLINE DREAM PURE BB BEAUTY BALM (SALICYLIC ACID) LOTION [L'OREAL USA PRODUCTS INC]5Current NDC, Legacy NDC, 1 package rows20241225_553bea8f-92cd-416c-8bc1-39e4ec9cfcb4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Salicylic acidACTIVE INGREDIENTO414PZ4LPZ1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-95749967-957-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic acidO414PZ4LPZACTIB
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
ISODODECANEA8289P68Y2IACT
GLYCERINPDC6A3C0OXIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
KAOLIN24H4NWX5COIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
SODIUM CHLORIDE451W47IQ8XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER2P2G24V6T9IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
SODIUM HYDROXIDE55X04QC32IIACT
DISODIUM STEAROYL GLUTAMATE45ASM2L11MIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
CHLORPHENESINI670DAL4SZIACT
PERLITE0SG101ZGK9IACT
LUVISET 36005BG6GY6YKIACT
TOCOPHEROLR0ZB2556P8IACT
ASCORBYL PALMITATEQN83US2B0NIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
DIPROPYLENE GLYCOLE107L85C40IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
IRON OXIDES1K09F3G675IACT

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 Dream Pure BB Beauty BalmSALICYLIC ACIDL'Oreal USA Products Inc553bea8f-92cd-416c-8bc1-39e4ec9cfcb42024-12-23WarningsExact identifier
ndc (package): 49967-957-01
ndc (product): 49967-957
ndc11 (package): 49967095701
spl id: 03dc29ef-b434-4df1-bcb0-ddd9bd9dd9c7
spl set id: 553bea8f-92cd-416c-8bc1-39e4ec9cfcb4

Reported adverse events (FAERS/openFDA)#

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