FDA.reportPublic FDA data

BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15

Product NDC
64141-019
11-digit product format
641410019
Labeler code
64141
Product ID
64141-019_29664f61-a51b-67fb-e063-6394a90a18f8
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE, and OCTISALATE
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Bobbi Brown Professional Cosmetics Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-02-01
Substance
AVOBENZONE; OCTINOXATE; OCTISALATE
Active strength
3; 7.5; 3.5 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100g
OCTINOXATE7.5 g/100g
OCTISALATE3.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4bfbfac7-6738-4996-a152-95dfbd759154Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-08-04BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15
2022-07-29BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15
2021-08-09BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15
2021-07-23BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64141-019-01BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 1515 g in 1 JARLIPSTICK1510
64141-019-01BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 151 in 1 CARTONLIPSTICK110

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
.beta.-citronellol, (r)-INACTIVE INGREDIENTP01OUT964KBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
arabica coffee beanINACTIVE INGREDIENT3SW678MX72BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
avocado oilINACTIVE INGREDIENT6VNO72PFC1BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
benzyl benzoateINACTIVE INGREDIENTN863NB338GBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
caprylyl glycolINACTIVE INGREDIENT00YIU5438UBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
castor oilINACTIVE INGREDIENTD5340Y2I9GBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
cholesterolINACTIVE INGREDIENT97C5T2UQ7JBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
D&C Red No. 6INACTIVE INGREDIENT481744AI4OBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
geraniolINACTIVE INGREDIENTL837108USYBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
glyceryl distearateINACTIVE INGREDIENT73071MW2KMBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
isomethyl-.alpha.-iononeINACTIVE INGREDIENT9XP4LC555BBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
microcrystalline waxINACTIVE INGREDIENTXOF597Q3KYBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
octyldodecanolINACTIVE INGREDIENT461N1O614YBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
octyldodecyl stearoyl stearateINACTIVE INGREDIENT3D47Q6D93CBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
oleic acidINACTIVE INGREDIENT2UMI9U37CPBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
olive oilINACTIVE INGREDIENT6UYK2W1W1EBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
palmitic acidINACTIVE INGREDIENT2V16EO95H1BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
phytosphingosineINACTIVE INGREDIENTGIN46U9Q2QBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
soybean oilINACTIVE INGREDIENT241ATL177ABOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
wheat germ oilINACTIVE INGREDIENT14C97E680PBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1
yellow waxINACTIVE INGREDIENT2ZA36H0S2VBOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64141-019BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LIPSTICK [BOBBI BROWN PROFESSIONAL COSMETICS INC.]10Current NDC, Legacy NDC, 2 package rows20241218_4bfbfac7-6738-4996-a152-95dfbd759154.zip

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 167 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Well People Bio Tint SPF 30 Sunscreen 12wZINC OXIDEe.l.f. Cosmetics, Incc8a99278-21e0-c517-e053-2a95a90ade372025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 1CZINC OXIDEe.l.f. Cosmetics, Incc8a82c8b-e308-15e9-e053-2995a90afa2a2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 14wZINC OXIDEe.l.f. Cosmetics, Incc8aa4629-1573-48a7-e053-2995a90aa86c2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 2wZINC OXIDEe.l.f. Cosmetics, Inc.c8a82f54-839d-1de0-e053-2a95a90a2a972025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 4WZINC OXIDEe.l.f. Cosmetics, Incc8a83921-3181-396e-e053-2a95a90a02ee2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 3NZINC OXIDEe.l.f. Cosmetics, Incc8aa6047-ce3e-59f7-e053-2a95a90a678e2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 5NZINC OXIDEe.l.f. Cosmetics, Incc8aa6047-ce42-59f7-e053-2a95a90a678e2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 6wZINC OXIDEe.l.f. Cosmetics, Incc8a8ef6f-4426-a981-e053-2a95a90a94512025-11-07WarningsExact identifier
application number: M020
Well People Lip Butter SPF 15 Sunscreen PEACHZINC OXIDEe.l.f. Cosmetics, Incc8aa931b-a3b4-6804-e053-2995a90a3eab2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 7NZINC OXIDEe.l.f. Cosmetics, Incc8aa6047-ce45-59f7-e053-2a95a90a678e2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 8NZINC OXIDEe.l.f. Cosmetics, Incc8aa662c-0f06-712b-e053-2995a90aae0b2025-11-07WarningsExact identifier
application number: M020
Well People Lip Butter SPF 15 Sunscreen AFTERGLOWZINC OXIDEe.l.f. Cosmetics, Incc8aa9325-4fad-ddf9-e053-2a95a90a66392025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 9wZINC OXIDEe.l.f. Cosmetics, Incc8a92c58-d981-0948-e053-2a95a90a16f82025-11-07WarningsExact identifier
application number: M020
Well People Lip Butter SPF 15 Sunscreen WINEZINC OXIDEe.l.f. Cosmetics, Incc8aa873e-8271-8cf0-e053-2995a90a3cec2025-11-07WarningsExact identifier
application number: M020
Well People Lip Butter SPF 15 Sunscreen NATURALZINC OXIDEe.l.f. Cosmetics, Incc8aa7ae9-7d03-db7d-e053-2995a90ae72b2025-11-07WarningsExact identifier
application number: M020
Neutrogena Clear Face Serum Fragrance Free SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCeb705402-f8cb-5079-e053-2a95a90a405c2025-11-06WarningsExact identifier
application number: M020
Neutrogena Cool Dry Sport Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC5c1a0437-c269-4cd3-b91a-e2de799b853e2025-11-06WarningsExact identifier
application number: M020
Neutrogena Clear Face Breakout Free oil Free Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC10ca67ca-c372-44a9-8933-84cce9fb99342025-11-06WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0464448b-342b-4e54-a20e-6ec6bd6228892025-11-06WarningsExact identifier
application number: M020
Neutrogena Hydro Boost Water Gel Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC7f60d6bd-1735-4390-bc8a-e3876ab7ad502025-11-06WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64141-019-01641410019011 JAR in 1 CARTON (64141-019-01) / 15 g in 1 JAR1 jar2002-02-010000-00-00NoNoCurrent