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 300 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF30 Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC37d696d9-f89d-498e-8fe9-1f08d05d7b612024-04-18WarningsExact identifier
application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 50OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDEGalderma Laboratories, L.P.6650d137-e69e-4ec2-8311-3de74bf213152024-04-17WarningsExact identifier
application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Berry SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEco Lips. Inc.e5e84e60-4339-460d-e053-2a95a90ad1522024-04-17WarningsExact identifier
application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Mint SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEco Lips. Inc.e64c4a2d-134e-999a-e053-2a95a90a64ee2024-04-17WarningsExact identifier
application number: M020
SPF 30 Mineral Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC0bc21573-d302-4d85-8d8f-dca9a48e1f352024-04-17WarningsExact identifier
application number: M020
Differin Oil Absorbing Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.4d5978c7-3575-4b5b-97bd-5f3c89412baf2024-04-17WarningsExact identifier
application number: M020
Cancer Council Everyday Active SPF50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.16381c8f-f954-f0be-e063-6394a90ae4012024-04-16WarningsExact identifier
application number: M020
The Nethercutt Collection Sunscreen Stick SPF 30 Broad Spectrum Sunscreen SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEEco Lips. Inc.163a2994-d95a-5752-e063-6394a90aec5d2024-04-16WarningsExact identifier
application number: M020
The Nethercutt Collection Hemp Vanilla SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEEco Lips. Inc.163ac1c1-7403-9d60-e063-6294a90a1cc02024-04-16WarningsExact identifier
application number: M020
CetaphilOCTOCRYLENE, AVOBENZONEGalderma Laboratories, L.P.2a6bc3f2-4e52-252b-d051-94be1ee0cc002024-04-16WarningsExact identifier
application number: M020
Cetaphil Oil Absorbing SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.73ed545b-460f-4287-8643-a02b0641fd452024-04-16WarningsExact identifier
application number: M020
SUN CONTROL BROAD SPECTRUM SPF 30HOMOSALATE, OCTISALATE, ZINC OXIDESKINPLAN.US LLC8e34a343-7253-469f-9973-076a7ae26cbc2024-04-15WarningsExact identifier
application number: M020
Cancer Council Protect and Hydrate Radiance SPF50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.1622c351-6e69-eeaf-e063-6294a90acd252024-04-15WarningsExact identifier
application number: M020
Hydrating Mineral Sunscreen BS SPF30ZINC OXIDEAllure Labs16268c31-2151-20e0-e063-6294a90a79652024-04-15WarningsExact identifier
application number: M020
Cancer Council Daily Body Moisturizer SPF50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.16296d3e-286a-e015-e063-6394a90a41892024-04-15WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Productionf9645435-e138-45df-a5ec-6dc7b3ff792d2024-04-08WarningsExact identifier
application number: M020
Degil Sun SPF 50 SunscreenHOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENEDegil Safety Products (1989) Inc155aa0c5-6403-ee86-e063-6294a90a1c4d2024-04-05WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip SPF 15 AssortedHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECarma Laboratories, Inc.ff9eae5b-4963-429d-bb73-8e3b5402f0842024-04-05WarningsExact identifier
application number: M020
Lemongrass Spa Products SPF 45 Mineral SunscreenZINC OXIDELemongrass Spa Products15469260-d4e5-8423-e063-6394a90aafae2024-04-04WarningsExact identifier
application number: M020
Clearly Zinq Tinted Hydrating Facial SPF Growth Factor 35ZINC OXIDEAllure Labs1548faf9-8623-f871-e063-6394a90a931f2024-04-04WarningsExact 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