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 312 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATETekweld Solutions, Inc.ea9f4d57-b00c-48ce-b833-9690be98bffd2023-12-26WarningsExact identifier
application number: M020
Best Skin Days BS SPF 30ZINC OXIDEAllure Labs0d7072f8-e808-5270-e063-6294a90a1ffa2023-12-26WarningsExact identifier
application number: M020
Lancome Paris Bienfait MultiVital Broad Spectrum SPF 30 SunscreenAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incf0d6518b-d795-4740-a301-1804a932ec452023-12-23WarningsExact identifier
application number: M020
Lancome Paris Skin Feels Good Broad Spectrum SPF 23 Sunscreen Hydrating Skin Tint Healthy GlowOCTINOXATEL'Oreal USA Products Inc4f4a8c37-af08-4bf7-89bc-1e487417c1462023-12-23WarningsExact identifier
application number: M020
Lancome Paris Skin Feels Good Broad Spectrum SPF 23 Sunscreen Hydrating Skin Tint Healthy GlowOCTINOXATESICOS ET CIE7051f505-f874-4214-ad4f-55a956cc35a72023-12-23WarningsExact identifier
application number: M020
Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating DayAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc08645f1d-7ba7-4410-8600-3d3f79d713852023-12-23WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Lift and Firming Face and Neck All Skin TypesAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incfc847725-b7a9-41f1-a605-d1d892fed06f2023-12-23WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Lift Firming Face Neck For All Skin TypesAVOBENZONE, OCTISALATE AND OCTOCRYLENESICOS ET CIEdf67b49c-f8b6-4c0a-9e8d-c94dee3635ff2023-12-23WarningsExact identifier
application number: M020
Lancome Paris Absolue Premium Bx Replenishing Rejuvenating Broad Spectrum SPF 15 DayAVOBENZONE, OCTISALATE AND OCTOCRYLENESICOS ET CIEa9b7e52c-8799-49ba-8b05-7559fe6668fe2023-12-23WarningsExact identifier
application number: M020
sugar rush skin treat poreless tinted moisturizer Broad Spectrum SPF 20 Sunscreen fairTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.32569352-c51e-4f05-a8b0-749ef916a5af2023-12-22WarningsExact identifier
application number: M020
Circadia Circa-Shield Mineral Sunscreen SPF 30ZINC OXIDECircadia by Dr Pugliese, Inc.2959aa56-be7f-4721-9701-e6d6e12cc8502023-12-22WarningsExact identifier
application number: M020
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen IvoryTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc0adb52f5-4e1f-4570-9b6f-584e4da61d9f2023-12-22WarningsExact identifier
application number: M020
ESTEE LAUDER DOUBLE WEAR SOFT GLOW MATTE CUSHION MAKEUP BROAD SPECTRUM SPF 36OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDEESTEE LAUDER INCc670635a-63d8-4b0b-afd7-b26e969f93a12023-12-21WarningsExact identifier
application number: M020
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 16N fair-light neutralTITANIUM DIOXIDETarte, Inc.62fffef6-29ae-4137-b0b9-fb93d61679332023-12-21WarningsExact identifier
application number: M020
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 12N fair neutralTITANIUM DIOXIDETarte, Inc.889860fc-7fce-47e9-af28-a3b2aec04a0e2023-12-21WarningsExact identifier
application number: M020
JLo Beauty That Big Screen Broad Spectrum SPF 30 MoisturizerHOMOSALATE, OCTISALATE, AND ZINC OXIDEAscendant Beauty LLCcba4e886-c4c6-4377-8f4c-250aef4b95fb2023-12-21WarningsExact identifier
application number: M020
COOLA Full Spectrum 360 Refreshing Water Cream SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLCd12e30bd-88ee-4e34-ae63-c34766aed3a82023-12-20WarningsExact identifier
application number: M020
COOLA Liplux Hydrating Oil SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC2d2ad94c-ea13-43c0-ab7f-acecf4d2309f2023-12-20WarningsExact identifier
application number: M020
Coola Bare Republic Mineral Face-Lotion SPF 70TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%COOLA LLCa334a61d-5c5a-4f45-b202-6dd7bb3d250b2023-12-20WarningsExact identifier
application number: M020
Bare Republic Big Adventure Stick SPF 70TITANIUM DIOXIDE 3.5% ZINC OXIDE 16.9%COOLAe800f72f-8c8b-4a12-843f-1ee404055cf02023-12-20WarningsExact 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