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 | 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
2011-09-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:29:36

Label at a glance#

ProductEXTRA REPAIR MOISTURING BALM SPF 25
Active ingredientOCTINOXATE, HOMOSALATE, OXYBENZONE, AVOBENZONE
Label structure4 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] HOMOSALATE 5.00% [] OXYBENZONE 3.00% [] AVOBENZONE 2.00%

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: WATER [] C12-15 ALKYL ETHYLHEXANOATE [] BUTYLOCTYL SALICYLATE [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] PROPANEDIOL [] CETYL ALCOHOL [] CETEARYL ALCOHOL [] GLYCERYL STEARATE [] BIS-DIGLYCERYL POLYACYLADIPATE-2 [] POLYACRYLAMIDE [] TOCOPHERYL ACETATE [] NEOPENTYL GLYCOL DIHEPTANOATE [] SUCROSE [] POLYETHYLENE [] OLEA EUROPAEA (OLIVE) FRUIT EXTRACT [] SALVIA SCLAREA (CLARY) EXTRACT [] EPILOBIUM ANGUSTIFOLIUM EXTRACT [] TRITICUM VULGARE (WHEAT BRAN) EXTRACT [] PISUM SATIVUM (PEA) EXTRACT [] BAMBUSA VULGARIS (BAMBOO) EXTRACT [] ROSMARINUS OFFICINALIS (ROSEMARY) [] OENOTHERA BIENNIS (EVENING PRIMROSE) OIL [] PELARGONIUM GRAVEOLENS (GERANIUM) FLOWER OIL [] CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL [] CITRUS AURANTIUM AMARA (BITTER ORANGE) OIL [] ANTHEMIS NOBILIS (CHAMOMILE) [] WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT [] CHOLESTEROL [] LINOLEIC ACID [] CAFFEINE [] ACETYL HEXAPEPTIDE-8 [] SORBITAN STEARATE [] PEG-40 STEARATE [] C13-14 ISOPARAFFIN [] CAPRYLYL GLYCOL [] DICETYL PHOSPHATE [] CETETH-10 PHOSPHATE [] LAURETH-7 [] GLUCOSAMINE HCL [] TETRAHEXYLDECYL ASCORBATE [] SODIUM HYALURONATE [] SODIUM HYDROXIDE [] HEXYLENE GLYCOL [] XANTHAN GUM [] CITRIC ACID [] TETRASODIUM EDTA [] GERANIOL [] LINALOOL [] LIMONENE [] CITRAL [] CITRONELLOL [] PHENOXYETHANOL

WARNINGS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOBBI BROWN

EXTRA

REPAIR MOISTURIZING

BALM SPF 25


1.7 OZ./50 ML


DISTR. BOBBI BROWN PROFESSIONAL COSMETICS

NEW YORK, NY 10022

FOLDING CARTONFOLDING CARTON

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64141-112-012019-10-29C16284748780-1960f7f55-cdb2-8e05-e053-dbdaa90a074a1e73c840-d69c-4e34-a6c0-00203ab3c24b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64141-112-01EXTRAREPAIR MOISTURING BALM SPF 251 in 1 CARTONCREAM11
64141-112-02EXTRAREPAIR MOISTURING BALM SPF 2550 mL in 1 JARCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64141-112EXTRA REPAIR MOISTURING BALM SPF 25 (OCTINOXATE, HOMOSALATE, OXYBENZONE, AVOBENZONE) CREAM [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1Legacy NDC, 2 package rows20110920_1e73c840-d69c-4e34-a6c0-00203ab3c24b.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
ACETYL HEXAPEPTIDE-3INACTIVE INGREDIENTL4EL31FWIL1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
BAMBUSA VULGARIS TOPINACTIVE INGREDIENTFIW80T6P6V1
BLACK OLIVEINACTIVE INGREDIENT2M6QWV94OC1
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D31
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE701
CAFFEINEINACTIVE INGREDIENT3G6A5W338E1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CETETH-10 PHOSPHATEINACTIVE INGREDIENT4E05O5N49G1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CHAMAEMELUM NOBILEINACTIVE INGREDIENT7NF3GE7IWR1
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7J1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
CITRUS AURANTIUM FLOWER OILINACTIVE INGREDIENTD4BGE91OXH1
CITRUS MAXIMA FRUIT RINDINACTIVE INGREDIENT5NX3G75CA61
CLARY SAGEINACTIVE INGREDIENTU3HSK5JC0Q1
DIHEXADECYL PHOSPHATEINACTIVE INGREDIENT2V6E5WN99N1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU1
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOPINACTIVE INGREDIENT08H094218D1
EVENING PRIMROSE OILINACTIVE INGREDIENT3Q9L08K71N1
GLUCOSAMINE HYDROCHLORIDEINACTIVE INGREDIENT750W5330FY1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75J1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR71
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
LAURETH-7INACTIVE INGREDIENTZ95S6G82011
LINOLEIC ACIDINACTIVE INGREDIENT9KJL21T0QJ1
NEOPENTYL GLYCOL DIHEPTANOATEINACTIVE INGREDIENT5LKW3C543X1
PEAINACTIVE INGREDIENTW4X7H8GYFM1
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q71
PELARGONIUM GRAVEOLENS FLOWERING TOPINACTIVE INGREDIENT1P36QZP48P1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PROPANEDIOLINACTIVE INGREDIENT5965N8W85T1
ROSEMARYINACTIVE INGREDIENTIJ67X351P91
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58X1
SUCROSEINACTIVE INGREDIENTC151H8M5541
WATERINACTIVE INGREDIENT059QF0KO0R1
WHEAT BRANINACTIVE INGREDIENT6L966A1IMR1
WHEYINACTIVE INGREDIENT8617Z5FMF61
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 2 · 49 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64141-11264141-112-02, 64141-112-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 47 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 462 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM / SUBLINGUAL10 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IMOUTHWASH / BUCCAL2 mg/1mlExact identifier — unii candidate
174 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / URETERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, EXTENDED RELEASE / ORAL529 mgExact identifier — unii candidate
21 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7CAPSULE / ORAL10 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
5 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JINJECTABLE, LIPOSOMAL / INTRAVENOUS437 mgExact identifier — unii candidate
10 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPOINTMENT / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAVENOUS396 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER, FOR SUSPENSION / ORAL9 mgExact identifier — unii candidate
174 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii candidate
29 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JOINTMENT / TOPICAL12 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / SUBCUTANEOUS26 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / EPIDURAL0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTABLE, LIPOSOMAL / INTRAVENOUS7560 mgExact identifier — unii candidate
48 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XAEROSOL, FOAM / TOPICAL0.55 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGRANULE, FOR SUSPENSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IFILM / BUCCAL0.09 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
48 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / RECTAL17 mgExact identifier — unii candidate
20 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / OPHTHALMICNAExact identifier — unii candidate
18 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SOINTMENT / TOPICAL1.2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE / ORAL238 mgExact identifier — unii candidate
88 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSPRAY / TOPICAL1 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii candidate
48 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING / ORAL83 mgExact identifier — unii candidate
88 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7JELLY / VAGINAL42.6 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISPRAY / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCAPSULE, EXTENDED RELEASE / ORAL9.43 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TRANSDERMAL472 mgExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET / ORAL914 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, DELAYED RELEASE / ORAL0.25 mgExact identifier — unii candidate
174 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XSUSPENSION / TOPICAL2.15 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JINJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS0.32 %w/vExact identifier — unii candidate
10 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates

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
9a0492aa-8a22-4f7c-a501-d08440de81851e73c840-d69c-4e34-a6c0-00203ab3c24b2011-09-19WarningsExact identifier
spl id: 9a0492aa-8a22-4f7c-a501-d08440de8185
spl set id: 1e73c840-d69c-4e34-a6c0-00203ab3c24b

Reported adverse events (FAERS/openFDA)#

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