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
G63QQF2NOXInternal UNII lookup
4X49Y0596WInternal 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 222 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Halo Glow Skin Tint SPF 50 84507ZINC OXIDEe.l.f. Cosmetics, Inc.31314118-0fd6-5549-e063-6394a90a9d1f2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84506ZINC OXIDEe.l.f. Cosmetics, Inc.313119be-c1f2-4cb0-e063-6294a90a03ca2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84516ZINC OXIDEe.l.f. Cosmetics, Inc.312dd439-5cc8-e034-e063-6394a90a5c762025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84504ZINC OXIDEe.l.f. Cosmetics, Inc.223efabb-d018-c337-e063-6394a90a56052025-03-25WarningsExact identifier
application number: M020
IT Cosmetics Your Skin But Better CC Plus Color Correcting Full Coverage Antiaging Hydrating Serum Broad Spectrum SPF 50 Plus Clear SunscreenHOMOSALATE, OCTISALATE AND OCTOCRYLENEIT COSMETICS, LLC9f8786cc-bef6-4449-8f31-dfc08de777342025-03-25WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Oil Free Matte Poreless Finish Full Coverage Broad Spectrum SPF 40 Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb7d184fb-4a9a-4720-9b00-bf0caa257a8c2025-03-25WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30cce5b1-ed41-5bf2-e063-6394a90aaf1d2025-03-24WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30df95da-4868-1414-e063-6294a90acdac2025-03-24WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30e1bd3c-6a0b-a8f8-e063-6394a90acfb72025-03-24WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30e1b4c9-0d77-b08a-e063-6394a90af6832025-03-24WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30e1ff3f-0fd0-2880-e063-6294a90a462f2025-03-24WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30e25241-0d2b-8c04-e063-6294a90a44b92025-03-24WarningsExact identifier
application number: M020
Walgreens SPF 50 Clear Complexion Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY311ae6d6-d466-3f1d-e063-6294a90ab3dd2025-03-24WarningsExact identifier
application number: M020
DOMINAS DARK SPOT TINTED SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H CO., LTD.2b6140cf-7e34-1658-e063-6394a90a32712025-03-24WarningsExact identifier
application number: M020
CVS Health SPF 70 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacy311de9db-941c-5af9-e063-6294a90a3a132025-03-24WarningsExact identifier
application number: M020
CVS Health SPF 70 Beach Guard ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacy311e6378-5afa-d7eb-e063-6394a90a77282025-03-24WarningsExact identifier
application number: M020
Naked Sundays Golden Glow Body Sunscreen SPF50 100mlNAKED SUNDAYS GOLDEN GLOW BODY SUNSCREEN SPF50 100MLNAKED SUNDAYS PTY LTDe182a39b-89b1-7756-e053-2a95a90ab6192025-03-23WarningsExact identifier
application number: M020
ANTIOXIDANT BODY SUNSCREEN CREME SPF50 BROAD SPECTRUMAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDeb7a84a8-3e25-9988-e053-2a95a90a58a92025-03-23WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01273e8c-aef0-d800-e063-6294a90abd492025-03-23WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01221d57-9eec-7e77-e063-6394a90a60422025-03-23WarningsExact 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