FDA.reportPublic FDA data

Burts Bees SPF 30 Untinted Lip Balm Beaches and Cream

Product NDC
51514-0369
11-digit product format
515140369
Labeler code
51514
Product ID
51514-0369_1ac89261-eeaf-567c-e063-6294a90ad45f
Type
HUMAN OTC DRUG
Nonproprietary name
Burts Bees SPF 30 Untinted Lip Balm Beaches and Cream
Dosage form
STICK
Route
TOPICAL
Labeler
Autumn Harp
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-01
Substance
ZINC OXIDE
Active strength
11.99 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
Burts Bees SPF 30 Untinted Lip Balm Beaches and Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE11.99 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ac89261-eeae-567c-e063-6294a90ad45fAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51514-0369-1Burts Bees SPF 30 Untinted Lip Balm Beaches and Cream4.25 g in 1 TUBESTICK4.251
51514-0369-2Burts Bees SPF 30 Untinted Lip Balm Beaches and Cream1 in 1 CARTONSTICK11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51514-0369BURTS BEES SPF 30 UNTINTED LIP BALM BEACHES AND CREAM STICK BURTS BEES SPF 30 UNTINTED LIP BALM TROPIC LIKE ITS HOT STICK BURTS BEES SPF 30 UNTINTED LIP BALM COCO LOCO STICK [AUTUMN HARP]1Current NDC, 2 package rows20240615_1ac89261-eeae-567c-e063-6294a90ad45f.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 19 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Sunscreen SPF 50MINERAL SUNSCREENALAINA HEALTHCARE PRIVATE LIMITED7e036f9f-b26d-4f11-911c-c1fa854edb0f2026-06-17WarningsExact identifier
application number: M020
Not there spf broad spectrum spf40 moisturizerAVOBENZONE 3% ,HOMOSALATE 10% ,OCTISALATE 5% ,OCTOCRYLENE 8% ,ZINC OXIDE 4%Foshan Sugar Max Cosmetics CO.,Ltd546f0474-4102-26d0-e063-6394a90a388b2026-06-17WarningsExact identifier
application number: M020
Ultra Violette Velvet Screen Blurring Mineral Skinscreen Broad Spectrum SPF 40ZINC OXIDEGrace and Fire USA Inc.52d4b1c1-7431-4f8c-e063-6294a90ad4822026-06-17WarningsExact identifier
application number: M020
EVIL GOODS TALLOW SUNSCREEN SPF30ZINC OXIDEMoes Group LLC54751f23-5723-0407-e063-6294a90a4a962026-06-17WarningsExact identifier
application number: M020
Amber Sunglaze Sheer Body Mist Sunscreen SPF30AVOBENZONE, OCTISALATE, OCTOCRYLENEKoco Life LLC5478fb36-e972-f824-e063-6294a90a567f2026-06-17WarningsExact identifier
application number: M020
Elaine Sterling Hydrating SunscreenZINC OXIDEElaine Sterling Enterprises5479e862-aca5-7541-e063-6394a90ad0c52026-06-17WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS545aa56a-ed07-acd6-e063-6394a90ae0c72026-06-16WarningsExact identifier
application number: M020
MAYBELLINE NEW YORK FIT ME DEWY PLUS SMOOTH FOUNDATION SPF 18 SUNSCREENOCTISALATELOreal USA Products Inc3b99ab06-ba4c-4ddd-a057-60028eedd67d2026-06-16WarningsExact identifier
application number: M020
TERRA LOTUS SPF 50 ORGANIC TALLOW SUNSCREENZINCOXIDEMoes Group LLC54617bf2-1d8d-531e-e063-6294a90a70802026-06-16WarningsExact identifier
application number: M020
Daily Defence Mineral Sunscreen SPF 50 Fragrance FreeZINC OXIDEUltraceuticals Pty Ltd5461ee82-0297-ce22-e063-6294a90a729b2026-06-16WarningsExact identifier
application number: M020
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
application number: M020
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
application number: M020
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
application number: M020
TITAN TALLOW SPF 50 ORGANIC TALLOW SUNSCREENZINC OXIDEMoes Group LLC546b0702-a3cc-fd6f-e063-6394a90af8492026-06-16WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET MINERAL SPF 30ZINC OXIDEWhole Foods Market, Inc.5ce712d6-cafd-4a80-9f8c-2149fdebff542026-06-16WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET MINERAL SPF 50ZINC OXIDEWhole Foods Market, Inc.1f8387be-d871-435b-baef-e537c67a510a2026-06-15WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 50OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND HOMOSALATEWhole Foods Market, Inc.82771f22-0197-40ba-97d2-2386152790ed2026-06-15WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWhole Foods Market, Inc.1c31f466-6a0d-46ce-9346-d2a0eb46c8d02026-06-15WarningsExact identifier
application number: M020
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
application number: M020
Solvyn Mineral Sunscreen SPF 50ZINC OXIDESolvyn Skin LLCb0a8d028-87d2-4339-8879-c62cbf8415f22026-06-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51514-0369-1515140369014.25 g in 1 TUBE4.25 gHistorical
51514-0369-2515140369021 TUBE in 1 CARTON (51514-0369-2) / 4.25 g in 1 TUBE (51514-0369-1) 1 tube2024-06-01NoNoCurrent