FDA.reportPublic FDA data

Intense Therapy Lip Balm Mango and Mandarin

Product NDC
66738-034
11-digit product format
667380034
Labeler code
66738
Product ID
66738-034_5aff7be2-1747-989c-e063-6394a90a1bb4
Type
HUMAN OTC DRUG
Nonproprietary name
Sunscreen Skin Protectant Lip Balm
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Jack Black, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-03
Substance
OCTINOXATE; AVOBENZONE; PETROLATUM
Active strength
75; 30; 402 g/1000g; g/1000g; g/1000g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Intense Therapy Lip Balm Mango and Mandarin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE75 g/1000g
AVOBENZONE30 g/1000g
PETROLATUM402 g/1000g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
G63QQF2NOXInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8c55d1cd-cdd6-468b-8a17-b940c6210116Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66738-034-25Intense Therapy Lip Balm Mango and Mandarin7 g in 1 TUBEOINTMENT75

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66738-034INTENSE THERAPY LIP BALM MANGO AND MANDARIN (SUNSCREEN SKIN PROTECTANT LIP BALM) OINTMENT [JACK BLACK, LLC]5Current NDC, Legacy NDC, 1 package rows20231110_8c55d1cd-cdd6-468b-8a17-b940c6210116.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 259 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zoey naturals Broad Spectrum SPF 50 Fragrance Free SunscreenZINC OXIDEAbsolutely Natural6e05e060-a531-4c4a-b273-889407ec57042024-12-11WarningsExact identifier
application number: M020
Peptide Lip Shine SPF30 SunscreenZINC OXIDEColorescience, Inc.98cdf19d-8b8a-4051-88bb-79160b2af39e2024-12-11WarningsExact identifier
application number: M020
Zoey naturals Broad Spectrum SPF 50Plus Fragrance Free SunscreenZINC OXIDEAbsolutely Natural082983a4-7b98-489d-8ac2-a185923b86ba2024-12-11WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 50 SunscreenZINC OXIDEAbsolutely Natural89657538-904d-4908-ba7b-6f84706a80012024-12-11WarningsExact identifier
application number: M020
SISLEYA Global Anti-Age Hand care SPF 15AVOBENZONE, OCTINOXATE, OCTISALATEC.F.E.B. Sisleycddf11b1-a89b-4b54-b228-55ba8147f0222024-12-10WarningsExact identifier
application number: M020
SUNLEYA Age minimizing sun care SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEC.F.E.B. Sisley67498d45-0871-4806-8854-81d3e50c4b902024-12-10WarningsExact identifier
application number: M020
SUPER CREME SOLAIRE CORPS Body sun care SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEC.F.E.B. Sisley1c774aa7-8963-4221-b4b0-b894bd1b941f2024-12-10WarningsExact identifier
application number: M020
Tinted Sunscreen Cream SPF 30 4-Deep AmberTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley5599922a-b020-477c-a44c-1db42ec5756a2024-12-10WarningsExact identifier
application number: M020
SUNLEYA Age minimizing sun care SPF 50 plusAVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENEC.F.E.B. Sisley7c9fadaf-b961-4df0-89ae-87141b50b2c12024-12-10WarningsExact identifier
application number: M020
Tinted Sunscreen SPF 30 1-NaturalTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisleyb3d53a10-2647-492a-a05f-b97c3f716aa82024-12-10WarningsExact identifier
application number: M020
Tinted Sunscreen SPF 30 2-GoldenTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley389cbce6-552c-4633-babd-7b672632f0b92024-12-10WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC28f08236-1f01-d759-e063-6294a90adcfa2024-12-10WarningsExact identifier
application number: M020
Blistex Five Star Lip Protection Broad SpectrumHOMOSALATE, OCTISALATE, AVOBENZONE, AND DIMETHICONEBlistex Inc.47b57317-7df5-442e-a3a4-1d44fe278ac62024-12-10WarningsExact identifier
application number: M020
AHAVA Brightening Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltd724bbb91-e273-4926-9ad6-a1657ffe4cd82024-12-10WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d83c576-5dfb-583a-e063-6294a90a2a282024-12-09WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d833e3b-5330-3c5b-e063-6394a90a2ed22024-12-09WarningsExact identifier
application number: M020
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d9533ba-5606-4116-e063-6294a90ad3b12024-12-09WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d82121d-1dc2-cd99-e063-6394a90aa7662024-12-09WarningsExact identifier
application number: M020
Attitude Kids Oatmeal sensitive mineral sunscreen unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude310e66a2-8714-4016-87f4-81c1fef19ec92024-12-09WarningsExact identifier
application number: M020
Attitude Oatmeal sensitive mineral sunscreen unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitudeb6b8733d-6431-4ed2-9350-c63bb901c8042024-12-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66738-034-25667380034257 g in 1 TUBE (66738-034-25) 7 g2011-08-030000-00-00NoNoCurrent