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 36 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
White Mint SPF 15 Broad Spectrum Lip BalmWHITE MINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc50ff8c38-94f1-f589-e063-6294a90a5ba82026-05-04WarningsExact identifier
application number: M020
Surface Sun SPF 50 MineralZINC OXIDESurface Products Corpcabaf7e1-b940-4d6e-b21b-d99c3a4047a72026-05-04WarningsExact identifier
application number: M020
SPF 50 Dry Touch Continuous No fragranceHOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Surface Products Corp503d6b48-3516-4264-9fe8-71a9939669fe2026-05-04WarningsExact identifier
application number: M020
Surface SPF 50 3oz Tinted mineral sunscreen with Water ResistanceZINC OXIDESurface Products Corp02b770cf-7351-444b-b2c8-ad112e9bea3e2026-05-04WarningsExact identifier
application number: M020
SPF 30 Dry Touch Continuous No fragranceHOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Surface Products Corpd13c9e6e-a5da-4691-8792-9d6025e166d72026-05-04WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUMTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC0206c676-c24d-470e-adb2-7cb3173f37272026-05-04WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - TANTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC5c5aad09-9f93-4634-8db1-c67570b38b2b2026-05-04WarningsExact identifier
application number: M020
OBGE PORE-ZERO Oil CONTROL SUN StickHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAdapt Inc.67209e46-1b7a-42df-b31f-fcb3cefbd7e12026-05-03WarningsExact identifier
application number: M020
EquateOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEWALMART INC2617e5bc-27a2-f187-e063-6394a90a69802026-05-03WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Rice Tinted Mineral Sun CreamZINC OXIDETHANK YOU FARMER CO., LTD20a44597-3d44-f0ea-e063-6294a90a903d2026-05-03WarningsExact identifier
application number: M020
Ultra Violette Sheen Screen Hydrating Lip Balm Last Bite Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEGrace and Fire USA Inc.4df3e90e-98a0-edbf-e063-6394a90ae3c92026-05-01WarningsExact identifier
application number: M020
Ultra Violette Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum SPF 50AVOBENZONE, OCTINOXATE, OCTOCRYLENEGrace and Fire USA Inc.4df6d28b-64ce-59b3-e063-6394a90a63602026-05-01WarningsExact identifier
application number: M020
EXTREME PROTECT SPF 30OCTINOXATE, ZINC OXIDESCIENCE OF SKINCARE LLCecc4d304-e7e2-45b6-b9b2-2c64d36308602026-05-01WarningsExact identifier
application number: M020
Blue Lizard Sport SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories4955fa1c-789d-4f42-af75-70223310644a2026-05-01WarningsExact identifier
application number: M020
Blue Lizard Kids SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesba4ae906-48c0-8384-e053-2995a90afb912026-05-01WarningsExact identifier
application number: M020
Sun Shield Mineral UV Barrier Protect Broad Spectrum SPF 40 SunscreenZINC OXIDEObagi Cosmeceuticals LLC54a3f855-48de-4ae0-b1f0-e957398530652026-05-01WarningsExact identifier
application number: M020
MEDICUBE PDRN HYDRATING UV SERUMHOMOSALATE, OCTOCRYLENE, OCTISALATE, ENSULIZOLEAPR US INC50a73981-985a-0a70-e063-6394a90a89cf2026-04-30WarningsExact identifier
application number: M020
Sky and Sol Body SunscreenNON- NANO ZINC OXIDEDelta Ecommerce LLC2ddaa628-0e81-c8a7-e063-6394a90a84f42026-04-30WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6831832a-e52e-43ea-899f-f5d44bea5a942026-04-30WarningsExact identifier
application number: M020
Carmex 10 count variety pack Lip BalmOCTINOXATE, OXYBENZONE, CAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.9c5168d5-31ed-4ce1-b16a-5f51f7e44ed22026-04-30WarningsExact 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