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 313 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coola Bare Republic Mineral Body Gel-Lotion SPF 30ZINC OXIDE 18.2%COOLA LLCd745d12e-8741-4bf2-89ec-c6f72a8d548b2023-12-20WarningsExact identifier
application number: M020
COOLA Classic Body Sunscreen SPF 70 - Peach BlossomAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC6efa0d9f-0ff3-4b2f-9587-9630261bcbd12023-12-20WarningsExact identifier
application number: M020
sugar rush skin treat poreless tinted moisturizer Broad Spectrum SPF 20 Sunscreen lightTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.b49d5dc5-8d9b-49e4-8d07-d0d6af3fbbdc2023-12-20WarningsExact identifier
application number: M020
Coola Bare Republic Mineral Face Gel-Lotion SPF 30ZINC OXIDE 18.2%COOLA LLCad1614d4-5421-473d-a1e8-0ff18491df772023-12-20WarningsExact identifier
application number: M020
COOLA CLASSIC FACE SUNSCREEN White Tea Broad Spectrum SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEBentley Laboratories, LLC4e0e426d-f037-428f-98f2-2d3e945bd0402023-12-19WarningsExact identifier
application number: M020
COOLA Classic Body Sunscreen Fragrance-Free SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEBentley Laboratories, LLC57f2fdeb-2abc-4ad3-bb89-5faee883c0e52023-12-19WarningsExact identifier
application number: M020
Baby Bare Republic Mineral Sunscreen SoftStick SPF 50ZINC OXIDECOOLA LLC1a603f62-86ec-4e66-a73f-718c5d0126762023-12-19WarningsExact identifier
application number: M020
COOLA Classic Body Sunscreen Pina Colada SPF 30AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEBentley Laboratories, LLCd508cef6-977f-4231-8c19-491569e999212023-12-19WarningsExact identifier
application number: M020
Nudestix Daily Mineral Veil SPF 30 Tint - HotZINC OXIDE 15%Bentley Laboratories, LLCa9e7a203-52f0-4a67-b3ea-65ff0968ec182023-12-19WarningsExact identifier
application number: M020
COOLA Refreshing Water Mist SPF 18AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBentley Laboratories, LLC658bf3fe-2246-40b6-8cb1-969bfdaffd1b2023-12-19WarningsExact identifier
application number: M020
Nudestix Daily Mineral Veil SPF 30 Tint Free - CoolZINC OXIDE 15%Bentley Laboratories, LLCcd80661f-348c-4bfd-a85c-041db1a1d0f42023-12-19WarningsExact identifier
application number: M020
Nudestix Daily Mineral Veil SPF 30 Tint - WarmZINC OXIDE 15%Bentley Laboratories, LLCd5fd3fea-5dcf-42ef-927a-3b4a3e1ccff82023-12-19WarningsExact identifier
application number: M020
foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 13N fair neutralTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.f5d54e9d-4963-419a-a091-bdbd1decd2b82023-12-19WarningsExact identifier
application number: M020
CHEVOURI Brightening Serum Broad Spectrum SPF-40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECHE'VOURI LLC5a93d5f9-9313-4194-8c39-c513f5a858532023-12-18WarningsExact identifier
application number: M020
Valentino Very Valentino Light Lasting Perfecting Foundation Broad Spectrum SPF 26 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE9598949a-0dd6-4932-9dc8-354f9e10b6012023-12-18WarningsExact identifier
application number: M020
BB blur tinted moisturizer Broad Spectrum SPF 30 lightTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.207aaa0c-777f-4abd-96b7-64666eb87f532023-12-18WarningsExact identifier
application number: M020
Valentino Very Valentino Light Lasting Perfecting Foundation Broad Spectrum SPF 26 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc69e0d803-be76-4cc3-bdeb-b50401d5d6d42023-12-18WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 DeepTITANIUM DIOXIDE AND ZINC OXIDECosmetique Active Production8bdd63f7-2f67-4280-9484-d6c8e80ad9b92023-12-16WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium DeepTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8ab49def-c9cd-489e-a936-467067a889402023-12-16WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium DeepTITANIUM DIOXIDE AND ZINC OXIDECosmetique Active Production0cb8f22d-2343-415e-9f16-1791567864a12023-12-16WarningsExact 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