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 89 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVERYRAY SUNCARE SUNSHINE SERUMEVERYRAY SUNCARE SUNSHINE SERUMGuangzhou Fantesy Biotechnology Co.,Ltd062be336-2af4-10e2-e063-6294a90a480a2026-01-05WarningsExact identifier
application number: M020
sunscreen powderSUNSCREEN POWDERGuangzhou Fantesy Biotechnology Co.,Ltdfae8ecaf-7a9c-902b-e053-6394a90a5f312026-01-05WarningsExact identifier
application number: M020
ORLASKIN HYDRATING SUNSCREENORLASKIN HYDRATING SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd0808b0cd-2cfb-8554-e063-6294a90ad6c42026-01-05WarningsExact identifier
application number: M020
DALLAS JAMES SKINCARE CO. SPF 50 SunscreenDALLAS JAMES SKINCARE CO. SPF 50 SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd225faeec-4f96-e082-e063-6394a90a9a312026-01-05WarningsExact identifier
application number: M020
LING NEW YORK Save Face Broad Spectrum SPF 30LING NEW YORK SAVE FACE BROAD SPECTRUM SPF 30Guangzhou Fantesy Biotechnology Co.,Ltd1dfa80bd-495a-18fb-e063-6394a90a4d0d2026-01-05WarningsExact identifier
application number: M020
Sky and Sol Sunscreen SPF30SKY AND SOL SUNSCREEN SPF30Guangzhou Fantesy Biotechnology Co.,Ltd1d917329-dea2-e792-e063-6294a90a0a0d2026-01-05WarningsExact identifier
application number: M020
Sky and Sol Sunscreen SPF50SKY AND SOL SUNSCREEN SPF50Guangzhou Fantesy Biotechnology Co.,Ltd1c699b06-c156-b0da-e063-6294a90a947d2026-01-05WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC228fab45-e0d2-f219-e063-6294a90a1ef62026-01-05WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC228055ec-ff59-4412-e063-6394a90abe142026-01-05WarningsExact identifier
application number: M020
SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION236bdb53-d7a5-43a2-8a0c-bce4a5522e262026-01-05WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAYAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION4bd99626-690b-49e8-8c42-a2e2dbca09bf2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE LONG-LASTING HYDRATING VEILAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf04ece6c-66b6-48e9-8f6b-e898a538ba002026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FOUNDATION N I10OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION05ffb157-5e28-4e94-866d-9e3371480d842026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE CONCEALER N 1TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONeedf8065-8897-4773-9cbb-bab57d2dd04f2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE BRIGHTENING ENHANCER VEILOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbb00d6d7-cc51-4fee-a0df-68bbd5bc50d62026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbeefe840-6f32-483b-8a37-2696adb8eea12026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE PROTECTIVE LIP TREATMENT SPF 25AVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONaddd9885-362c-4ce0-9a6e-759e71d8756c2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION65ca1240-6ee8-40c0-b62f-3597e0872c6e2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE CORRECTING VEIL n MENSULIZOLE, OCTINOXATE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION15a258a0-61c3-4419-bcdb-a8197d5ae46f2026-01-05WarningsExact identifier
application number: M020
Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.098c0a9b-2b96-6be3-e063-6294a90a959a2026-01-05WarningsExact 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