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
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal 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 20 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kiss My Face Purely Mineral Face Factor 50 Sunscreen SPF 50ZINC OXIDEWindmill Health Products, LLC9771aa6d-a797-42d5-919b-3bf67ef5e0402026-06-15WarningsExact identifier
application number: M020
Cellular Swiss UV Protection Veil SPF30OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONELa Prairie, Inc.dd946a3b-74b9-4ebd-b82f-0350f8f728342026-06-15WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET SPORT MINERAL SPF 30ZINC OXIDEWhole Foods Market, Inc.6caf656c-246f-469e-84f8-98f80b84c65e2026-06-15WarningsExact identifier
application number: M020
EVIL GOODS TALLOW SUNSCREEN SPF50ZINC OXIDEMoes Group LLC543058d4-f375-d702-e063-6394a90a26402026-06-14WarningsExact identifier
application number: M020
LASSO TALLOW SUNSCREEN SPF 50ZINC OXIDEMoes Group LLC54312883-1d40-121e-e063-6294a90a247d2026-06-14WarningsExact identifier
application number: M020
SFL SUNSCREEN - SOL DEFENSE SPF 30TITANIUM DIOXIDE, ZINC OXIDELifeline Medical, Inc5438c185-31c9-c51e-e063-6394a90ae9ef2026-06-14WarningsExact identifier
application number: M020
Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC54106748-9810-d3ff-e063-6394a90a5b7a2026-06-12WarningsExact identifier
application number: M020
Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC5410e0ed-aed5-3279-e063-6294a90a0c3e2026-06-12WarningsExact identifier
application number: M020
Target Up and Up Ultra Light Dry-Touch SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION5411f284-f4ed-4e0e-e063-6294a90af1f62026-06-12WarningsExact identifier
application number: M020
Target Up and Up Oil Control SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION54141120-7682-9c05-e063-6394a90a877e2026-06-12WarningsExact identifier
application number: M020
Rejuvaskin Mineral Facial Sunscreen SPF 32 SheerREJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEERAtlantic Medical Products , LLC1a2ab632-6443-1aa9-e063-6394a90a0c052026-06-11WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Natural Matte Color Correcting Pore Refining Full Coverage Skin Balancing Serum Broad Spectrum SPF 40 SunscreenENSULIZOLE, OCTISALATE AND TITANIUM DIOXIDEIT COSMETICS, LLCf2990320-b61d-40b8-ba79-18d6b37e7f522026-06-11WarningsExact identifier
application number: M020
Lancome Paris UV Expert Supra Screen Invisible Sunscreen Serum Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc6c1c9ae3-650f-4cf6-bf21-d3d5229ec2fa2026-06-11WarningsExact identifier
application number: M020
Lancome Paris UV Expert Supra Screen Invisible Sunscreen Serum Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENESICOS ET CIE3c196ac0-dc07-40ad-865c-8177c75c935a2026-06-11WarningsExact identifier
application number: M020
BelleJoss BROAD SPECTRUM SPF 50BROAD SPECTRUM SPF 50Guangzhou Liyan Cosmetics Technology Co., Ltd.53e1b5ba-45fc-e811-e063-6394a90a65ac2026-06-10WarningsExact identifier
application number: M020
MilaMiAmor SPF50 Sunscreen Lotion50mLOCTINOXATE 7.5%, ZINC OXIDE 5%Foshan Sugar Max Cosmetics CO.,Ltd5379c00f-8222-6d12-e063-6294a90a8fad2026-06-10WarningsExact identifier
application number: M020
HEY HOTTIE Shimmer dry oil mist sunscreen spf30OCTOCRYLENE,OCTINOXATEGuangdong Aimu Biological Technology Co., Ltd53f19c01-0011-bc70-e063-6294a90ab8792026-06-10WarningsExact identifier
application number: M020
SUNPLUS Solar Sheer SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONESUNPLUS SKIN CARE LLC86bffd22-dded-404e-8d8e-4c54082ce50f2026-06-09WarningsExact identifier
application number: M020
Acewink SunscreenSUNSCREEN SPRAYShenzhen Qiming Biotechnology Co., Ltd.53d19fa8-6f0e-2c11-e063-6294a90abb032026-06-09WarningsExact identifier
application number: M020
RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d76b02-442e-7a5d-e063-6394a90ae1b32026-06-09WarningsExact 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