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
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal 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
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 210 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naturium Phyto-Glow Lip Balm SPF 45-GetawayAVOBENZONE, HOMOSALATE, OCTISALATEe.l.f. Cosmetics, Inc.3808613f-88d6-6c1a-e063-6294a90a5bb22025-06-09WarningsExact identifier
application number: M020
1000 Roses Daily Shade Facial SPF 18OCTISALATE, OCTOCRYLENE, AND AVOBENZONEAndalou naturals0923e090-6834-4373-80fe-21f00b8c1c172025-06-09WarningsExact identifier
application number: M020
dAlba Vegan Fresh Sun CushionZINC OXIDE, HOMOSALATE, OCTOCRYLENEADMTMAX LLC20afcbab-a2f4-7965-e063-6294a90a83d12025-06-08WarningsExact identifier
application number: M020
dAlba Vegan Mild SunscreenZINC OXIDEADMTMAX LLC20ab5698-cd9f-0821-e063-6394a90a60d72025-06-08WarningsExact identifier
application number: M020
dAlba Vegan Fresh Sun StickHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATEADMTMAX LLC20ae82ae-bc8f-89d1-e063-6394a90afff22025-06-08WarningsExact identifier
application number: M020
dAlba Vegan Essence SunscreenHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATEADMTMAX LLC1ccfa213-2f83-ad50-e063-6294a90a38bf2025-06-08WarningsExact identifier
application number: M020
Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/MediumZINC OXIDEPacifica Beauty, LLC36ec6c9d-f7dc-0419-e063-6294a90a55e62025-06-06WarningsExact identifier
application number: M020
Pacifica Ultra CC Cream Radiant Foundation SPF 30 Neutral/FairZINC OXIDEPacifica Beauty, LLC36ed9101-249a-922c-e063-6394a90a26082025-06-06WarningsExact identifier
application number: M020
Rodan and Fields Reverse Brightening Defense Broad Spectrum SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERodan & Fields Beauty, LLCafa2d42e-b54d-4843-b313-0c44fe5c5d522025-06-06WarningsExact identifier
application number: M020
1000 Roses CC Color Plus Correct Sheer Tan SPF 30ZINC OXIDEAndalou naturals9314e4fc-ba3e-480e-a005-b8928130ed702025-06-06WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Face Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC3169bf3b-a5a8-4c3e-a182-9f24f8ade3ac2025-06-05WarningsExact identifier
application number: M020
Body Glove Sunscreen SPF 30ZINC OXIDE, TITANIUM DIOXIDESCUBASCREEN LLC1d7a960c-4387-44dc-8d4e-881e21a8ae2e2025-06-05WarningsExact identifier
application number: M020
Vacation Classic Mini Whip SPF 30 Broad Spectrum SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.36d65cb2-c2e7-06d7-e063-6394a90a38222025-06-05WarningsExact identifier
application number: M020
Vacation Classic Whip SPF 50 Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.36d747fb-b973-5611-e063-6394a90ac6612025-06-05WarningsExact identifier
application number: M020
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d7c8b3-554f-78d9-e063-6394a90a80f32025-06-05Exact identifier
application number: M020
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d80422-943f-3aba-e063-6294a90afb592025-06-05Exact identifier
application number: M020
Mineral Creme SPF 50 Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesf8e178d6-058c-462a-8e59-6721f28ad0402025-06-05WarningsExact identifier
application number: M020
Mineral Tinted SPF 30 Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesadcd6881-fa25-4312-95e5-5b47102aa6b92025-06-05WarningsExact identifier
application number: M020
Mineral Moisture Defense SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences05ad73f3-a4e8-4f78-8212-3e8e3bda988c2025-06-05WarningsExact identifier
application number: M020
Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences6ce602bb-c1f4-43c1-ae61-0f05d7952db32025-06-05WarningsExact 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