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 318 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDEThe Honest Company, Inc.c172d584-7cb6-a078-e053-2995a90ac78f2023-12-05WarningsExact identifier
application number: M020
EltaMD UV SheerZINC OXIDE AND OCTOCRYLENE SUNSCREENCP Skin Health Group, Inc.2564e811-70f5-4d00-be8e-686b55e316302023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c1720cff-a897-68cb-e053-2995a90a30b62023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c12272c3-d4ed-2212-e053-2995a90add372023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c12272c3-d4f0-2212-e053-2995a90add372023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c1228ca6-8fb4-5964-e053-2a95a90a30ca2023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c12292a8-c98f-eb27-e053-2a95a90a9bbc2023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDEThe Honest Company, Inc.c172d22a-0315-8e84-e053-2995a90a30b52023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDEThe Honest Company, Inc.c172cabe-faab-6458-e053-2995a90aef662023-12-05WarningsExact identifier
application number: M020
Sea Clearly Translucent Gel Sunscreen BS SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAllure Labs0bb4ec66-64ba-9583-e063-6394a90ac5122023-12-04WarningsExact identifier
application number: M020
Clearly Zinq Mineral Gel Sunscreen BS SPF 60ZINC OXIDEAllure Labs0bb7f0a4-13df-7734-e063-6294a90a242b2023-12-04WarningsExact identifier
application number: M020
RECHARGE Regimen for Balancing, Boosting and Defending Healthy-Looking skinTITANIUM DIOXIDE, ZINC OXIDERodan & Fieldsb7401ff8-ca47-4c74-813c-99c5f28c0b6d2023-12-04WarningsExact identifier
application number: M020
Eminence Bright Skin Moisturizer SPF 40 SunscreenZINC OXIDEEminence Organic Skin Care4f2ba93d-ec19-40c1-b4ca-53898841f55b2023-12-02WarningsExact identifier
application number: M020
Lilikoi Mineral Defense Sport Sunscreen SPF 30ZINC OXIDEEminence Organic Skin Care Ltd.5375522a-17e3-48a1-8248-dd811c3823bf2023-12-02WarningsExact identifier
application number: M020
Eminence Lilikoi Daily Defense Moisturizer SPF 40 SunscreenZINC OXIDEEminence Organic Skin Careedc9972a-affd-4099-aec1-3549a07fa83c2023-12-02WarningsExact identifier
application number: M020
Perbelle CC SPF43 UVA UVB Broad SpectrumTITANIUM DIOXIDEPerbelle Cosmetics Global Ltd.b5e2724e-9806-5bcc-e053-2a95a90a05082023-12-01WarningsExact identifier
application number: M020
A PERFECT WORLD SPF 40 AGE DEFENSE BROAD SPECTRUM MOISTURIZER WITH WHITE TEAAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.abd8b302-a01c-478d-919a-22e686cb88da2023-12-01WarningsExact identifier
application number: M020
SHADE and ILLUMINATE SOFT RAD PRMR SPFOCTINOXATE,OCTISALATE,ZINC OXIDETOM FORD BEAUTY DISTeac7d416-c243-4647-e053-2a95a90abcb72023-12-01WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c1228d15-a157-6989-e053-2995a90a44ea2023-12-01WarningsExact identifier
application number: M020
CAO Cosmetic Lip Sunscreen SPF 30AVOBENZONE, OCTOCRYLENES & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITEDd912b9e9-f351-e2b0-e053-2a95a90a9ca22023-11-30WarningsExact 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