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 83 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunscreen Lotion118mLZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46355437-4068-9d03-e063-6394a90ae52c2026-01-09WarningsExact identifier
application number: M020
ST MORIZ SUNCARE FACE SUNSCREEN SPF30SUNCARE FACE SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.47f26af6-4d02-3506-e063-6294a90a0fe62026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sun 6 SPF Tan and Care CarrotOCTINOXATEFarmasi US LLC67de9257-70f3-4444-a4a2-a8d7425fcc0e2026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sunscreen SPF30 Broad SpectrumAVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATEFarmasi US LLCd9197dce-20a3-4d10-807c-ec84ab9021652026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Lumi Radiance BrighteningOCTOCRYLENE, OCTINOXATE, AVOBENZONEFarmasi US LLCadf5621b-7cf0-53b3-e053-2a95a90a80582026-01-09WarningsExact identifier
application number: M020
Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15HOMOSALATE, OCTINOXATEFARMASI US LLC1dbd5e83-2248-4751-88d9-b446ccc3c61e2026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sunscreen 50 SPF UVA UVB Protection Face and Body SunAVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATEFarmasi US LLC27fdbd2b-60de-4906-a176-5c5198d9925b2026-01-09WarningsExact identifier
application number: M020
Skin Metal StealthZINC OXIDESkin Metal47f5d7de-5d32-041a-e063-6394a90ab6f92026-01-09WarningsExact identifier
application number: M020
Salt and Blue Body Sunscreen SPF 30ZINC OXIDE 20%Salt + Blue LLC47f764a0-e9ad-ef66-e063-6394a90a8de52026-01-09WarningsExact identifier
application number: M020
City Sunscreen serum Broad Spectrum SPF 30 SupergoopHOMOSALATE, OCTISALATE, AVOBENZENE, OCTOCRYLENESupergoop, LLC61766f7b-512d-45b5-b652-e09975a3d3fc2026-01-09WarningsExact identifier
application number: M020
Defense Refresh (Re)Setting Mist SPF 40AVOBENZONE, HOMOSALATE , OCTISALATE, OCTOCRYLENESupergoop LLCb95ad8e3-978b-b721-e053-2a95a90a1e542026-01-09WarningsExact identifier
application number: M020
Daily Dose Vitamin C and Broad Spectrum SPF 40 SerumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop LLCaed0dd03-1695-a5a9-e053-2995a90acfdc2026-01-09WarningsExact identifier
application number: M020
Hand Screen Broad Spectrum Sunscreen SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENESupergoop, LLC972ebab9-3f2f-6716-e053-2a95a90a5c752026-01-09WarningsExact identifier
application number: M020
Glow Oil Broad Spectrum Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC972c68e7-b137-34c6-e053-2a95a90a77d62026-01-09WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Coconut SPF 15 Scented Lip GlossHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCee045b64-7a95-4378-8183-e6e556f3b1842026-01-09WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Papaya SPF 15 Scented Lip GlossHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC967d0657-18fc-4e4a-b52d-442df43329f12026-01-09WarningsExact identifier
application number: M020
PLAY SPF 30 Lip Shield CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCb0b8b850-bdfe-5563-e053-2995a90a51a72026-01-09WarningsExact identifier
application number: M020
Play SPF 30 Lip Shield StrawberryAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCb0a49142-53c3-5b7a-e053-2995a90a581d2026-01-09WarningsExact identifier
application number: M020
Glow Stick Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENESupergoop, LLC61e543e3-9ace-6440-e053-2991aa0a96472026-01-09WarningsExact identifier
application number: M020
(RE) Setting 100% Mineral Powder Translucent Broad Spectrum Sunscreen SPF 35ZINC OXIDESupergoop, LLCaf5c9801-26ce-5c60-e053-2995a90ab4572026-01-09WarningsExact 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