FDA.reportPublic FDA data

BBW SPF 35 Berry Lip Balm

Product NDC
51514-0366
11-digit product format
515140366
Labeler code
51514
Product ID
51514-0366_0f8b024c-c482-951b-e063-6394a90ac63c
Type
HUMAN OTC DRUG
Nonproprietary name
BBW SPF 35 Berry Lip Balm
Dosage form
STICK
Route
TOPICAL
Labeler
Autumn Harp
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-22
Substance
HOMOSALATE; OCTISALATE; AVOBENZONE
Active strength
10; 5; 2.5 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
BBW SPF 35 Berry Lip Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE10 g/100g
OCTISALATE5 g/100g
AVOBENZONE2.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0f8b024c-c481-951b-e063-6394a90ac63cAvailable 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51514-0366-1BBW SPF 35 Berry Lip Balm4 g in 1 TUBESTICK41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51514-0366BBW SPF 35 PINK DREAM LIP BALM STICK BBW SPF 35 BERRY LIP BALM STICK BBW SPF 35 NATURAL LIP BALM STICK [AUTUMN HARP]1Current NDC, 1 package rows20240123_0f8b024c-c481-951b-e063-6394a90ac63c.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 87 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Loretta Universal Glow Daily Defense SPF 40ZINC OXIDEDr. Loretta, LLC1208d0f8-bb12-4574-b70e-3a76b11a64c72026-01-07WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Sunscreen SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKDC/One Development Corporation, Inc.259f3fe3-2967-6c05-e063-6394a90a9e452026-01-07WarningsExact identifier
application number: M020
Hawaiian Blend Extreme Zinc SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group4084dd98-357f-4011-b0d4-db6536d2931f2026-01-07WarningsExact identifier
application number: M020
Hawaiian Blend Extreme Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group9b4acc5e-fdaf-4fcb-83a9-69e430dd43de2026-01-07WarningsExact identifier
application number: M020
Hawaiian Blend Sensitive Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Groupb42261c5-fa6e-4bb3-93c0-97032ab9f7162026-01-07WarningsExact identifier
application number: M020
CabanaMilk Mineral Barrier Fluid SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD47d0fe4d-ad21-1004-e063-6394a90a9c192026-01-07WarningsExact identifier
application number: M020
CENTELLA RELIEF SOOTHING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEIUNIK Co., Ltd.47d170e3-dd76-d413-e063-6294a90ae8e42026-01-07WarningsExact identifier
application number: M020
Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad SpectrumZINC OXIDESEORIN COMPANY Co., Ltd.1e7cc417-3c57-c87c-e063-6394a90a670b2026-01-07WarningsExact identifier
application number: M020
Proactiv Clear Skin SPF 30AVOBENZONE, OCTISALATE, AND OCTOCRYLENEAlchemee, LLCb0aa7ff0-f712-486f-aaaf-f88fed3b5cd12026-01-07WarningsExact identifier
application number: M020
Daily Hydrating Mineral Body Sunscreen Broad Spectrum SPF 30 SunscreenZINC OXIDEOak Essentials, LLC47d37f44-10b2-214f-e063-6294a90a5abc2026-01-07WarningsExact identifier
application number: M020
PLUMSCREEN SPF 31ZINC OXIDELe Prunier Farms, Inc.e20eb996-2b64-6bd0-e053-2a95a90a4f922026-01-07WarningsExact identifier
application number: M020
BETA-GLUCAN MILD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEIUNIK Co., Ltd47d6ad8b-1081-ee21-e063-6294a90a0e632026-01-07WarningsExact identifier
application number: M020
Koobarra Mineral Face Sunscreen SPF 50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED37cf8143-99f2-cca5-e063-6394a90a19a82026-01-07WarningsExact identifier
application number: M020
Solar Swipe Mineral Sunscreen SPF50SOLAR SWIPE MINERAL SUNSCREEN SPF50Guangzhou Fantesy Biotechnology Co.,Ltd47d75d61-5295-3eab-e063-6394a90a01c12026-01-07WarningsExact identifier
application number: M020
LUXURY SUN RITUAL PORE SMOOTHING SPF 30 SUNSCREENZINC OXIDEJANE STREET LLCdbdd3e6a-f09d-90cf-e053-2a95a90a98a02026-01-07WarningsExact identifier
application number: M020
RENEWALUXE SPF 50 SunscreenRENEWALUXE SPF 50 SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd1bc29960-5e73-e8ab-e063-6294a90a3f802026-01-06WarningsExact identifier
application number: M020
ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREENSPF50Wild Child Laboratories PTY Ltd2767ba3e-7434-d474-e063-6294a90aa4ff2026-01-06WarningsExact identifier
application number: M020
ULTRA VIOLETTE SPF ON THE GLOW Duo Pack KitSPF 50Grace And Fire USA Inc.47b7da8a-ea89-1402-e063-6294a90a23f92026-01-06WarningsExact identifier
application number: M020
Hawaiian Blend Essential Zinc SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group5a6e622f-2c00-406a-8860-d7081656f5972026-01-06WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Neutral 5OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION66c22f17-5418-42ff-97b2-33fa10f5eac32026-01-06WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51514-0366-1515140366014 g in 1 TUBE (51514-0366-1) 4 g2024-01-22NoNoCurrent