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 330 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 2NENSULIZOLE, OCTISALATEParfums Christian Diorc790b9e4-6925-4796-9945-1c5484116a232023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 2WENSULIZOLE, OCTISALATEParfums Christian Diorf551db8d-7447-41b9-9249-5ee8f76be98a2023-11-03WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior775f4009-9fc2-475b-a141-b4b5e55421802023-11-03WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 030OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior189f8767-f463-4c83-8a38-975ce8672b2a2023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 1,5NENSULIZOLE, OCTISALATEParfums Christian Diord9c6e0e0-f88e-48ba-94db-0cb198f8dbbe2023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 3NENSULIZOLE, OCTISALATEParfums Christian Diora1e5e9cf-3f59-4e1d-98d6-f17ed1ad8e512023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 2CRENSULIZOLE, OCTISALATEParfums Christian Dior2345d277-3d46-4dfc-9c5d-db7887165ea62023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 5NENSULIZOLE, OCTISALATEParfums Christian Diorcfd207af-d650-4333-a79a-c8f4878e8f9a2023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 7NENSULIZOLE, OCTISALATEParfums Christian Dior5f5e61e3-ea93-401b-b55c-1eb0a711e7382023-11-03WarningsExact identifier
application number: M020
FOREVER SKIN VEIL Extreme Wear and Moisturizing Primer Correction, Protection, Illumination With Sunscreen Floral Extract-Enriched Broad Spectrum SPF20OCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc59b4ece-0534-4072-afe8-2142a43c6bb22023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 4NENSULIZOLE, OCTISALATEParfums Christian Diorcfeb19b9-6597-4bd7-a635-d4024e291c5c2023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 6NENSULIZOLE, OCTISALATEParfums Christian Diorc044849f-94ab-4d91-aac5-e3e9631bc8b12023-11-03WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 030OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Diorcdc2a156-5ccd-4d40-98af-c529f0911a9e2023-11-03WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h Wear Radiant Perfection Skin Caring Foundation With Sunscreen BROAD SPECTRUM SPF 35 Lasting Hydration 2WPOCTINOXATE, TITANIUM DIOXIDEPARFUMS CHRISTIAN DIOR6ee0284e-739d-4aad-9352-9ea9c106efa42023-11-03WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Coconut Lip BalmZINC OXIDERaining Rose, Inc.2a03abc4-824b-438d-acc5-4698530576792023-11-03WarningsExact identifier
application number: M020
BEAUTY BEFORE AGE AHAVA UPLIFT DAY broad spectrum SPF 20HOMOSALATE, OCTISALATE, AND AVOBENZONEAHAVA Dead Sea Laboratories Ltdbf872bbe-a2d1-4188-b331-e62e339b13e72023-11-03WarningsExact identifier
application number: M020
All Good Broad Spectrum SPF 15 Spearmint Lip BalmBROAD SPECTRUM SPF 15 SPEARMINT LIP BALMRaining Rose, Inc.77370d4e-6888-4cb7-b6b9-1011a71dbf7a2023-11-03WarningsExact identifier
application number: M020
365 Everyday ValueSPORT LOTION MINERAL SUNSCREEN SPF 30Whole Foods Market, Inc.8f15b988-c009-4ca7-bb46-c0fb0aa626432023-11-03WarningsExact identifier
application number: M020
365 Everyday ValueSPORT LOTION MINERAL SUNSCREEN SPF 30Whole Foods Market, Inc.706ed90d-fd98-44bf-99b8-f8c12eec68572023-11-03WarningsExact identifier
application number: M020
THE SOF FLUID LONG WEAR FOUNDATION BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INC97787725-9175-46a7-8e3a-af5d06e21d7f2023-10-30WarningsExact 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