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 335 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Broad Spectrum SPF 30 Sun StickBROAD SPECTRUM SPF 30 SUN STICKRaining Rose, Inca35a7973-443b-5247-e053-2a95a90a44592023-10-23WarningsExact identifier
application number: M020
Cranberry Orange SPF 15 Broad Spectrum Lip BalmCRANBERRY ORANGE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca8c3aa41-c9a0-4f64-e053-2995a90a005e2023-10-23WarningsExact identifier
application number: M020
Super Mint SPF 15 Broad Spectrum Lip BalmSUPER MINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9626a2f-9931-78d2-e053-2995a90ac40f2023-10-23WarningsExact identifier
application number: M020
Spearmint SPF 30 Broad Spectrum Lip BalmSPEARMINT SPF 30 BROAD SPECTRUM LIP BALMRaining Rose, Incb7b520dc-bae6-614f-e053-2995a90ae6772023-10-23WarningsExact identifier
application number: M020
Citrus SPF 15 Broad Spectrum Lip BalmCITRUS SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75d0651-6001-29ce-e053-2a95a90a967f2023-10-23WarningsExact identifier
application number: M020
Coconut Mineral SPF 15 Broad Spectrum Lip BalmCOCONUT MINERAL SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incb7b542fa-b0d2-7b33-e053-2995a90a71192023-10-23WarningsExact identifier
application number: M020
Vanilla SPF 30 Broad Spectrum Lip BalmVANILLA SPF 30 BROAD SPECTRUM LIP BALMRaining Rose, Incb7b542fa-b0c2-7b33-e053-2995a90a71192023-10-23WarningsExact identifier
application number: M020
Pineapple Mineral SPF 15 Broad Spectrum Lip BalmPINEAPPLE MINERAL SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incb7c6684f-1122-20c1-e053-2995a90ae6cf2023-10-23WarningsExact identifier
application number: M020
Farmasi CC Cream LIGHT to MEDIUM 02TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI28b3fdff-1986-4048-9ed5-a3d784a4014e2023-10-23WarningsExact identifier
application number: M020
Farmasi CC Cream- MEDIUM 03TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI65de3c45-8ec2-4d73-8a29-6203d3b47bd72023-10-23WarningsExact identifier
application number: M020
Farmasi BB Cream- MEDIUM 03TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI9102aa2f-0308-4985-b8a8-8e105047b61f2023-10-23WarningsExact identifier
application number: M020
Caribbean Breeze SPF 15 Broad Spectrum Lip BalmCARIBBEAN BREEZE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75a42f6-27d1-e2cc-e053-2a95a90aa6da2023-10-23WarningsExact identifier
application number: M020
Iced Pear SPF 15 Broad Spectrum Lip BalmICED PEAR SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca8c4a0ec-e07e-1cda-e053-2a95a90a0f3f2023-10-23WarningsExact identifier
application number: M020
Lemonade SPF 15 Broad Spectrum Lip BalmLEMONADE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca8ffc32b-b758-0f8f-e053-2995a90adb622023-10-23WarningsExact identifier
application number: M020
Strawberry SPF 15 Broad Spectrum Lip BalmSTRAWBERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca902d590-0726-ad6f-e053-2995a90a11302023-10-23WarningsExact identifier
application number: M020
Orange Creamsicle SPF 15 Broad Spectrum Lip BalmORANGE CREAMSICLE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9005cb1-ae1a-7736-e053-2995a90a28ea2023-10-23WarningsExact identifier
application number: M020
Neora Age IQ Invisi-Bloc SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeora, LLCf2f3601f-081a-4bae-e053-2a95a90a4fac2023-10-23WarningsExact identifier
application number: M020
Neora Age IQ Invisi-Bloc SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeora, LLC82f48635-1dc4-8c0d-e053-2991aa0a60cc2023-10-23WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Golden L4N1TITANIUM DIOXIDEAmway Corp7494fe09-40e0-4152-9974-a6e8a4d7f4212023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Soleil L3W1TITANIUM DIOXIDEAmway Corpcec51b88-a6b8-4b64-b3aa-830e712a3c8a2023-10-22WarningsExact 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