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
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal 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 11 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MEDICUBE PDRN SILKY SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAPR US INC57154bec-6714-0314-e063-6294a90a4bd02026-07-20WarningsExact identifier
application number: M020
TOCOBO Double UV Defense SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON Co., Ltd.56aff65a-aa08-dc3f-e063-6294a90acac32026-07-19WarningsExact identifier
application number: M020
THE SPORTO Invisible Sport for BodyAVOBENZONE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.46564a09-909d-bcc7-e063-6294a90a627b2026-07-17WarningsExact identifier
application number: M020
RR Sun CremeHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEUndefined Incdc60b685-a7fc-47bb-ade9-44a8e3b548122026-07-17WarningsExact identifier
application number: M020
Cetaphil Tinted Daily Facial Moisturizer SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEGalderma Laboratories, L.P.0ef2ebae-7198-47f4-8891-d1ca3cf54d4b2026-07-16WarningsExact identifier
application number: M020
Mederma Scar CreamAVOBENZONE, OCTOCRYLENE, AND OXYBENZONEPMI Branded Pharmaceuticals, Inc.f9be5adb-dce3-4b17-939f-d80d486f2cb02026-07-16WarningsExact identifier
application number: M020
BaseLife Pure Mineral Shield SunscreenZINC OXIDEWintech America, Inc.7f741a91-6ed8-4d08-9196-d15527d044d52026-07-15WarningsExact identifier
application number: M020
BaseLife Clear UV Defense SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWintech America, Inc.128db446-93ba-4347-bd39-66177572c6592026-07-15WarningsExact identifier
application number: M020
Biore Aqua Rich Facial Mist SPF 50OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKao USA Inc.56a80a0d-b0b5-1098-e063-6294a90a52702026-07-15WarningsExact identifier
application number: M020
Anti Aging Lip Balm Pot SPF 15LIP BALMEpicuren Disocovery4097e28a-ed11-e16a-e063-6294a90a5e9b2026-07-14WarningsExact identifier
application number: M020
HolyCow Mineral Tallow Sunscreen Face and Body SPF 50ZINC OXIDECALM ENTERPRISE LLC722462d8-d2ab-44ce-9065-673ab20762692026-07-14WarningsExact identifier
application number: M020
X-Treme Cream Propolis Sunscreen SPF 45X-TREME CREAMEpicuren Discovery3b29976e-eee0-b978-e063-6294a90accd62026-07-14WarningsExact identifier
application number: M020
Anti-Aging Lip Balm SPF 15LIP BALMEpicuren Discovery3cbd0550-b6e5-3e86-e063-6394a90ac07f2026-07-14WarningsExact identifier
application number: M020
Zinc Oxide Perfecting SunscreenZINC OXIDEEpicuren Discovery1a0228f9-bf3f-a1fe-e063-6294a90a3fb52026-07-14WarningsExact identifier
application number: M020
Vacation FaceAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.14b8a3cf-031c-4c52-ba81-e683e69d0f372026-07-14WarningsExact identifier
application number: M020
Mederma Scar CreamAVOBENZONE, OCTOCRYLENE, AND OXYBENZONEL. Perrigo Companybd5c9df7-8dfb-4d20-9966-e148c5667b222026-07-14WarningsExact identifier
application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Watermelon Sugar PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC4081a4ad-b738-5fb6-e063-6394a90a91712026-07-13WarningsExact identifier
application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Coconut Cream PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC3cc5c1d8-91f8-8ad2-e063-6294a90a92292026-07-13WarningsExact identifier
application number: M020
Olay Super Serum Body Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company5513c5e2-3baf-2f09-e063-6394a90a495a2026-07-13WarningsExact identifier
application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Peach Sky PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC3cc48592-f70d-664e-e063-6294a90ac6e82026-07-13WarningsExact 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