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 117 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Total Eye 3-In-1 Renewal Therapy SPF 35TITANIUM DIOXIDE AND ZINC OXIDEColorescience4b116cc4-94d2-4bfc-b7f9-5f486a194c6c2025-12-16WarningsExact identifier
application number: M020
Daily SPF Facial SunscreenLotion Broad Spectrum SPF 32ZINC OXIDEOnekind.25c11197f4-cee0-04b3-e053-2995a90a1ba82025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Medium DeepZINC OXIDECrunchi, LLC.69618265-2ebb-4cdc-a28f-e36c07fe5b8f2025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 MediumZINC OXIDECrunchi, LLC.23248bc3-1b82-443a-b38a-df7f0efb5d2a2025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 LightZINC OXIDECrunchi, LLC.cf4039f5-00ee-4227-a3dc-61995c8001352025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Body Sunscreen SPF 30ZINC OXIDECrunchi, LLC.227f5a41-8c3c-492d-947f-e2b046208bca2025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Light MediumZINC OXIDECrunchi, LLC.5b3f2766-065b-4817-a5ff-bd1c7882bfc92025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Daily Facial Sunscreen SPF 30ZINC OXIDECruchi, LLC.4f3bcfa0-e43e-4284-afaa-6488ddd749f02025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3543a22c-34d5-e572-e063-6394a90ad5792025-12-15Exact identifier
application number: M020
Stellar Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bb6488c-d216-8742-e063-6394a90a16e22025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bb8ee19-81b2-daed-e063-6394a90a0fb32025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bb6cfd4-fa4a-d1d9-e063-6394a90a8e432025-12-15WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC35442ac0-c361-e08f-e063-6294a90a5cb22025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3543e85d-9bc7-b8ed-e063-6294a90ae7d32025-12-15Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bc8593d-fc6c-04aa-e063-6394a90a6d562025-12-15WarningsExact identifier
application number: M020
Mineral Sunscreen 20percent Zinc OxideZINC OXIDEMANTRA WELLNESS SPA338855fd-3008-44d9-e063-6294a90a5e072025-12-15Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDEMANTRA WELLNESS SPA33898415-4ee6-a384-e063-6394a90ae8e12025-12-15Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMantra Wellness Spa3389b0a3-40f9-b411-e063-6394a90a99592025-12-15Exact identifier
application number: M020
Mineral Sunscreen 20percent Zinc OxideZINC OXIDEMantra Wellness Spa338a11fb-24c6-8a0b-e063-6294a90a761e2025-12-15Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDEMantra Wellness Spa338aa5a2-29e3-fe0e-e063-6294a90a18fd2025-12-15Exact 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