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 297 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RMS SUNCOVERUP SUPER TINT SPF 50 MAHOGANYZINC OXIDERms organics LLC1a1aebea-ed0c-ac92-e063-6294a90aeae62024-06-04WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Translucent Zinc OnlyZINC OXIDESPF Ventures, LLC1a1bf910-f1bc-bd75-e063-6294a90a663f2024-06-04WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD0b62062d-b77e-4e6c-b3ab-b35ab24db7cb2024-06-04WarningsExact identifier
application number: M020
Protectif Deep TintZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.19b19023-1340-6609-e063-6394a90a6eaf2024-05-30WarningsExact identifier
application number: M020
EltaMD UV Sport SPF50ZINC OXIDE, OCTINOXATE AND OCTISALATE SUNSCREENCP Skin Health Group, Inc.dffc3fde-5b6e-4a62-8289-9733be43455b2024-05-30WarningsExact identifier
application number: M020
Vacation by Vacation Scent and Shimmer DuoAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.aef8388f-84bb-4e2b-8ae2-aa64f415a6322024-05-28WarningsExact identifier
application number: M020
SPF50 Sunscreen CariposaZINC OXIDETalent Brands Company LLC1938fa13-875a-140e-e063-6294a90a55142024-05-24WarningsExact identifier
application number: M020
Derma E Vitamin C Weightless Moisturizer SPF 45ZINC OXIDEderma ea3b404a6-e4b1-4c08-a8ef-77446dd2e4112024-05-24WarningsExact identifier
application number: M020
COOLA Classic Liplux Lip Balm SPF 30 OriginalAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCeeb420f0-c92f-0d96-e053-2a95a90afe362024-05-22WarningsExact identifier
application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Nude BeachTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee2842c3-65e0-3904-e053-2a95a90aabff2024-05-22WarningsExact identifier
application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 FirecrackerTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee026a1c-885b-256f-e053-2a95a90af5642024-05-22WarningsExact identifier
application number: M020
Bare Republic SPF 50 Mineral Sunscreen Vanilla CocoTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCec96dee8-85e8-3147-e053-2995a90aaf532024-05-22WarningsExact identifier
application number: M020
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Bronze GoddessTITANIUM DIOXIDECOOLA, LLCeeb406c6-a543-379a-e053-2995a90a49982024-05-22WarningsExact identifier
application number: M020
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh RoseTITANIUM DIOXIDECOOLA, LLCee01642f-478e-b307-e053-2a95a90a7d812024-05-22WarningsExact identifier
application number: M020
Bare Republic SPF 30 Mineral Sunscreen Coco MangoZINC OXIDECOOLA, LLCeca9ae89-19dc-516d-e053-2995a90a46982024-05-22WarningsExact identifier
application number: M020
Bare Republic Mineral Matte Untinted Face SPF 30TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCecabcc89-fb09-41a9-e053-2995a90a8b312024-05-22WarningsExact identifier
application number: M020
Bare Republic Mineral Matte Tinted Face SPF 30TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee018c21-dca7-28aa-e053-2a95a90a3bdb2024-05-22WarningsExact identifier
application number: M020
Bare Republic SPF 30 Mineral Sunscreen Citrus CoolerZINC OXIDECOOLA, LLCecaad342-1873-60bc-e053-2995a90a59522024-05-22WarningsExact identifier
application number: M020
Bare Republic Mineral Shimmer SPF 30 Golden DazeTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCeeb70034-0f8d-a46d-e053-2a95a90a81302024-05-22WarningsExact identifier
application number: M020
Bare Republic Mineral Shimmer SPF 30 Diamond DustTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCeec83ecb-d0ab-7857-e053-2995a90a40ed2024-05-22WarningsExact 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