FDA.reportPublic FDA data

BOBBI BROWN EXTRA

Manufacturer
BOBBI BROWN PROFESSIONAL COSMETICS INC | ESTEE LAUDER COSMETICS, LTD | ESTEE LAUDER N.V. | Len-Ron Manufacturing Division of Aramis Inc. | Aramis Inc. | Northtec Bristol | Northtec Keystone | PADC 1 | Estee Lauder Pennsylvania Distribution Center 2 | Estee Lauder Cosmetics, Ltd. | Estee Lauder Cosmetics Distribution Center | Estee Lauder Kabushiki Kaisha | Whitman Laboratories Ltd. | Aveda Corporation
Effective date
2010-04-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:24:14

Label at a glance#

ProductBOBBI BROWN EXTRA SPF 25 MOISTURIZING BALM
Active ingredientHOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE
Label structure4 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:  HOMOSALATE 10.00% [] OCTINOXATE 7.50% [] OXYBENZONE 5.00% [] AVOBENZONE 2.00%

WARNINGS SECTION

WARNING:  KEEP OUT OF EYES.  STOP USE IF IRRITATION OCCURS.

OTC - WHEN USING SECTION

DIRECTIONS: WARM IN HANDS AND APPLY TO CLEAN SKIN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:


BOBBI BROWN

EXTRA

SPF 25 MOISTURIZING BALM

POIDS NET. 1.7 OZ / 50 ML


BOBBI BROWN PROFESSIONAL COSMETICS
NEW YORK, NY 10022
E109

WWW.BOBBIBROWN.COM
FOLDING CARTON
FOLDING CARTON

 

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64141-916-012019-10-21C16284748780-1956f9ecf-c3ae-621f-e053-dbdaa90a74ad62cc7bdd-e453-4edf-b6bc-d9acd1c07f53

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64141-916-01BOBBI BROWN EXTRASPF 25 MOISTURIZING BALM1 in 1 CARTONCREAM11
64141-916-02BOBBI BROWN EXTRASPF 25 MOISTURIZING BALM50 mL in 1 JARCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64141-916BOBBI BROWN EXTRA SPF 25 MOISTURIZING BALM (HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE) CREAM [BOBBI BROWN PROFESSIONAL COSMETICS INC]1Legacy NDC, 2 package rows20100415_62cc7bdd-e453-4edf-b6bc-d9acd1c07f53.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64141-91664141-916-02, 64141-916-01

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
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
AVOBENZONEG63QQF2NOXACTIB

Source Document#

Source XML · Source PDF

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
059d1056-8ed8-45e2-9a4a-9397eba1dd5e62cc7bdd-e453-4edf-b6bc-d9acd1c07f532010-04-14WarningsExact identifier
spl id: 059d1056-8ed8-45e2-9a4a-9397eba1dd5e
spl set id: 62cc7bdd-e453-4edf-b6bc-d9acd1c07f53

Reported adverse events (FAERS/openFDA)#

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