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 49 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sunscreen CreamAVOBENZONE, OCTISALATE, OCTOCRYLENEJiangsu Senwo Medical Technology Co., Ltd.4e615757-76b1-8f34-e063-6394a90a280a2026-04-01WarningsExact identifier
application number: M020
All Good Mineral Sport Sunscreen Sunstick SPF 30ZINC OXIDEElemental Herbs, Inc.4e67b76e-b791-4e26-e063-6294a90aa9912026-04-01WarningsExact identifier
application number: M020
All Good Coconut Mineral Sunscreen Sunstick SPF 30ZINC OXIDEElemental Herbs, Inc.4e67e89b-a7be-a540-e063-6294a90a6d8f2026-04-01WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAYAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEShiseido Americas Corporationcad3a446-36a8-4146-81b5-1cc8d65abf142026-04-01WarningsExact identifier
application number: M020
MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN BRIGHTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEForest Avenue Co., Ltd.8de4ec46-f60a-4c51-a16e-9140150e21622026-04-01WarningsExact identifier
application number: M020
ChapStick Moisturizer Cool Mint SPF 15SPF 15 LIP PROTECTANTSuave Brands Co., LLC42f50497-ded1-6863-e063-6294a90a39c82026-03-31WarningsExact identifier
application number: M020
Purito Sunday Adventure Sunscreen SPF 50, 50 mLAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHinaturebf16f535-97fc-4fd8-9310-8b6bbc82baae2026-03-31WarningsExact identifier
application number: M020
spf 50 mineral powder sunscreenTITANIUM DIOXIDE, ZINC OXIDESmalls Brand LLC DBA Roe Wellnessf8762dd1-0484-74ea-e053-6294a90ac1122026-03-31WarningsExact identifier
application number: M020
Badger SPF 30 Face Mineral SunscreenZINC OXIDEW.S. Badger Company, Inc.14a9b605-f1f0-00e5-e063-6394a90a5a512026-03-31WarningsExact identifier
application number: M020
Covergirl cgsmoothers BB Tinted Moisturizer Broad Spectrum SPF 21 (all shades)OCTINOXATE AND ZINC OXIDENoxell Corporation38bba282-b4f7-4374-8732-419400b1cc502026-03-31WarningsExact identifier
application number: M020
SeranovaTM ULTRALIGHT SPF50 SERUMSERANOVATM ULTRALIGHT SPF50 SERUMGuangzhou Ariel Biotech Co., Ltd.4e5d716d-2b2d-d42f-e063-6294a90a1e522026-03-31WarningsExact identifier
application number: M020
ageLOC Tru Face Radiant DayAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENENSE Products, Inc.3e9a0b39-4351-41df-81b2-88c1c15c0db22026-03-31WarningsExact identifier
application number: M020
Sunright Solar Screen Mineral Face SunscreenZINC OXIDENSE Products, Inc.93a32040-3a47-4d6f-baa1-5a4595bef4102026-03-31WarningsExact identifier
application number: M020
Lancome Paris Renergie HPN 300 Peptide Sunscreen Broad Spectrum SPF 25 High-Performance DayAVOBENZONE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc28f500e2-41d1-4747-8f26-3f6f8cc1b5832026-03-30WarningsExact identifier
application number: M020
Lancome Paris Renergie HPN 300 Peptide Sunscreen Broad Spectrum SPF 25 High-Performance DayAVOBENZONE, OCTISALATE, AND OCTOCRYLENESICOS ET CIEdd448b7a-2554-4dfc-9eb3-ec3486ec61972026-03-30WarningsExact identifier
application number: M020
ANUA MINERAL WEIGHTLESS FINISH SUNSCREENZINC OXIDEThefounders4e37d291-84fb-252a-e063-6294a90acd1f2026-03-30WarningsExact identifier
application number: M020
Beyond Glow Tinted Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDETHE AVON COMPANY4e43bea2-247d-fe11-e063-6294a90a33a32026-03-30WarningsExact identifier
application number: M020
Abib Quick sunstick Protection barHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONEFOURCOMPANY CO., LTD.1a2ab632-643f-1aa9-e063-6394a90a0c052026-03-30WarningsExact identifier
application number: M020
ChapStick Classic Original MilitarySKIN PROTECTANT LIP BALMSuave Brands Co., LLC4514490b-f348-4526-e063-6294a90ad5052026-03-30WarningsExact identifier
application number: M020
ChapStick Moisturizer Black Cherry SPF 15SPF 15 SKIN PROTECTANTSuave Brands Co., LLC42f40978-51ca-f448-e063-6294a90acf312026-03-30WarningsExact 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