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 326 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3WOCTISALATE, TITANIUM DIOXIDEGuerlain15fe0429-720c-4975-953d-285aa7ee12ce2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4WOCTISALATE, TITANIUM DIOXIDEGuerlain1a733548-75a4-41ec-8d8d-3e6e9aad52e02023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 8NOCTISALATE, TITANIUM DIOXIDEGuerlainf43c867a-161f-47b7-b3d8-7f7e6c6728042023-11-08WarningsExact identifier
application number: M020
Aruba Sun SPF 70 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCd96b4233-6d52-7621-e053-2a95a90a1b602023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0COCTISALATE, TITANIUM DIOXIDEGuerlain0d75be99-7607-4964-bb6e-3c731644ab4e2023-11-08WarningsExact identifier
application number: M020
Dead Sea Natural Face Moisturizer Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA Dead Sea Laboratories Ltddee4bdb8-5c6f-42f6-b15c-d109cd2d31402023-11-08WarningsExact identifier
application number: M020
Mineral Radiance Energizing Day BS SPF 15AVOBENZONE, HOMOSALATE, AND OCTISALATEAHAVA Dead Sea Laboratories Ltd4cb8b21c-7727-441a-9d61-c90d79ac45dc2023-11-08WarningsExact identifier
application number: M020
Jack Black Intense Therapy Lip Balm Passion FruitAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLCf34beb68-e5dc-45c4-a6d1-e9a0310162282023-11-08WarningsExact identifier
application number: M020
Private Label SPF45 Water Resistant Paraben Free SunscreenOCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLCf997f4fc-7da5-433c-9a53-2030b489b4f62023-11-07WarningsExact identifier
application number: M020
Private Label Moisturizing Oil Free Paraben Free SPF43SUNSCREENSwiss-American CDMO, LLC003e4221-f9d9-47c4-b10b-9876046b931a2023-11-07WarningsExact identifier
application number: M020
AHAVA ACTIVE DEADSEA MINERALS TIME TO ENERGIZE AGE CONTROL MOISTURIZING BROAD SPECTRUM SPF15AVOBENZONE, OCTISALATE, AND OCTOCRYLENEAHAVA Dead Sea Laboratories Ltd5a9ec221-a9ec-4473-8fb0-83f10ae775e22023-11-07WarningsExact identifier
application number: M020
Private Label Super Light Oil-Free SPF452.75% OCTINSALATE, 7.50% OCTINOXATE, 8.00% ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC6a08448a-46bc-4330-ae2d-f716bb4edfa72023-11-07WarningsExact identifier
application number: M020
GOLD MOUNTAIN BEAUTY Collagen Broad Spectrum SPF 30OCTINOXATE, OCTISALATE, ZINC OXIDETT Fitness, Inc617ef3af-4203-4664-b714-1b5fab2e0ee62023-11-06WarningsExact identifier
application number: M020
SEAWEED BATH CO. Clear Moisture Mineral SPF-30ZINC OXIDEThe Seaweed Bath Co.c241261c-d887-4ac2-89ce-93dcc0fce2672023-11-06WarningsExact identifier
application number: M020
JESS BEAUTY Let It Sun Sunscreen SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJESS BEAUTY PRODUCTS LLC88628c11-dbc7-4404-9701-7944a685a13d2023-11-06WarningsExact identifier
application number: M020
SEAWEED BATH CO. Sheer Mineral Sensitive SPF-50ZINC OXIDEThe Seaweed Bath Co.fdcfc7eb-da33-4461-a4f9-fe97ea6b873f2023-11-06WarningsExact identifier
application number: M020
SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-42TITANIUM DIOXIDE, ZINC OXIDESANTO REMEDIO LLC82d210bc-b7ca-4d74-be58-85f175a750582023-11-06WarningsExact identifier
application number: M020
CALIFORNIA MANGO SPF-50 SUNSCREENAVOBENZONE, OCTISALATE, OCTOCRYLENECALMANGO, INC183e523a-93ee-47ec-8bd4-5557af449ea52023-11-06WarningsExact identifier
application number: M020
Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDENEWCO LLCfa3c73a3-0dfb-4673-822a-45d946dee2602023-11-06WarningsExact identifier
application number: M020
JESS BEAUTY Sun Drops Sunscreen Oil SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJESS BEAUTY PRODUCTS LLC4e05e9d6-5127-44ca-a331-3004b2ddb5342023-11-06WarningsExact 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