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 324 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Personalized Day Moisturizer with SPFTITANIUM DIOXIDE, ZINC OXIDEProven Skincare3b6546ed-22ee-48e6-83cc-5cbadf5674992023-11-10WarningsExact identifier
application number: M020
Proven Personalized Day Moisturizer With SPF 50ZINC OXIDEProven Skincareba9b3cdc-c237-7ce2-e053-2995a90ac1752023-11-10WarningsExact identifier
application number: M020
MIAMI BEACH BUM Save Face SPF-30 SunscreenZINC OXIDEMIAMI BEACH BUM538742bc-d8f3-47d9-a85f-f2b1314f55072023-11-10WarningsExact identifier
application number: M020
Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut)TITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.4935f888-cd92-61d1-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M020
Coral Safe SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.4925a507-863f-1088-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M020
CoralSafe Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDEElements Brandse6e00896-b7e5-41c6-a72b-08e600758cf52023-11-10WarningsExact identifier
application number: M020
Coral Safe SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.4925a3ad-6379-108a-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M020
BELASOL Sun Cream Non-Tinted Moisturizing SPF 50TITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasolfb677ad0-2791-44ec-9720-951471ec009a2023-11-09WarningsExact identifier
application number: M020
Shaklee Youth Age Defense Mineral Moisturizer SPF 30TITANIUM DIOXIDEShaklee Corporationf4888fdc-09f9-43de-8c81-5a0f5e767d4e2023-11-09WarningsExact identifier
application number: M020
Raw Elements Eco 30 Broad Spectrum SPF 30ZINC OXIDERaw Elements LLCbcce6d5b-d641-4484-a4dd-06b81170f8632023-11-09WarningsExact identifier
application number: M020
Spit and Polish Mineral Face SPF 30ZINC OXIDENaturally Uncommon, LLCaf86fca8-571c-0cac-e053-2a95a90ae4022023-11-09WarningsExact identifier
application number: M020
Raw Elements Tint 30 Broad Spectrum SPF 30ZINC OXIDERaw Elements LLC801a616a-5007-4951-8bc5-b8ffe9f0bb192023-11-09WarningsExact identifier
application number: M020
Raw Elements Baby Kids Broad Spectrum SPF30ZINC OXIDERaw Elements LLCfda8fce8-a164-45b5-b6ca-b1efce4740892023-11-09WarningsExact identifier
application number: M020
Raw Elements Lip Rescue 30 Broad Spectrum SPF 30ZINC OXIDERaw Elements LLC74b8eac3-4bc6-430b-b4b9-eabe3280d7af2023-11-09WarningsExact identifier
application number: M020
Raw Elements Baby Kids Broad Spectrum SPF30 SunscreenZINC OXIDERaw Elements LLCa6e5f808-65c7-4810-a15c-413111216dae2023-11-09WarningsExact identifier
application number: M020
Raw Elements Eco Formula 30 Broad Spectrum SPF 30ZINC OXIDERaw Elements LLC1d130543-9e12-42f4-80b4-915dbe0f85d42023-11-09WarningsExact identifier
application number: M020
Raw Elements Facial Moisturizer Tint Formula 30 SPF 30 Broad SpectrumZINC OXIDERaw Elements LLC8aff5517-8b3d-490e-b821-973baea2d0792023-11-09WarningsExact identifier
application number: M020
Raw Elements Daily Moisturizer Broad Spectrum SPF30ZINC OXIDERaw Elements LLC92c5f11b-5585-4479-8ee3-315c7e72574f2023-11-09WarningsExact identifier
application number: M020
Big Mood SPF 30 Milky Lip BalmZINC OXIDEEveryday Group Limitedc83098af-3cf9-78f6-e053-2995a90a0d012023-11-09WarningsExact identifier
application number: M020
Spit and Polish Sun Smart SunscreenTITANIUM DIOXIDE, ZINC OXIDENaturally Uncommon, LLCaf879a05-1483-5c11-e053-2995a90af45d2023-11-09WarningsExact 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