FDA.reportPublic FDA data

TriLipiderm

Product NDC
60892-602
11-digit product format
608920602
Labeler code
60892
Product ID
60892-602_43466aba-a567-fa52-e063-6394a90a41a9
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Ethylhexyl methoxycinnamate,Butyl Methoxydibenzoylmethane, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
TriLipid Research Institute, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-12
Substance
OCTINOXATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE
Active strength
7.5; 3; 10; 2.7 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage60892-602-77fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage60892-602-16fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage60892-602-33fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage60892-602-7786f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage60892-602-1686f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage60892-602-3386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage60892-602-77bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage60892-602-16bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage60892-602-33bd6a592717d7…303034d00443…

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
TriLipiderm
Brand name suffix
Protective Day
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 g/100mL
AVOBENZONE3 g/100mL
HOMOSALATE10 g/100mL
OCTOCRYLENE2.7 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
66726c2b-27e9-5dd1-e053-2991aa0a1ba7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
60892-602-162023-10-09TriLipiderm Protective Day Creme
60892-602-162023-10-09TriLipiderm Protective Day Creme
60892-602-332023-10-09TriLipiderm Protective Day Creme
60892-602-332023-10-09TriLipiderm Protective Day Creme
60892-602-772023-10-09TriLipiderm Protective Day Creme
60892-602-772023-10-09TriLipiderm Protective Day Creme
60892-602-162022-01-28TriLipiderm Protective Day Creme
60892-602-162022-01-28TriLipiderm Protective Day Creme
60892-602-332022-01-28TriLipiderm Protective Day Creme
60892-602-332022-01-28TriLipiderm Protective Day Creme
60892-602-772022-01-28TriLipiderm Protective Day Creme
60892-602-772022-01-28TriLipiderm Protective Day Creme

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60892-602-15TriLipidermProtective Day15 mL in 1 BOTTLECREAM157
60892-602-16TriLipidermProtective Day1 in 1 BOXCREAM17
60892-602-32TriLipidermProtective Day50 mL in 1 BOTTLE, PUMPCREAM507
60892-602-33TriLipidermProtective Day1 in 1 BOXCREAM17
60892-602-77TriLipidermProtective Day4 mL in 1 PACKETCREAM47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60892-602TRILIPIDERM PROTECTIVE DAY (HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE,BUTYL METHOXYDIBENZOYLMETHANE, OCTOCRYLENE) CREAM [TRILIPID RESEARCH INSTITUTE, LLC]6Current NDC, Legacy NDC, 5 package rows20241115_66726c2b-27e9-5dd1-e053-2991aa0a1ba7.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 258 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Lip Balm SPF-15ZINC OXIDETUBBY TODD4d938672-5302-4e47-a582-c3e6467008cb2024-12-18WarningsExact identifier
application number: M020
SaltyFace Daily Sun Shield Mineral Sunscreen For Face SPF 30ZINC OXIDESaltyface Natural Incf0cc7ce9-81b3-439f-b5ee-96138de54e782024-12-18WarningsExact identifier
application number: M020
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50 JasmineTITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasole999d752-6c00-459e-b6c3-d264c330597d2024-12-18WarningsExact identifier
application number: M020
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasolf22626c1-0996-41d8-a2ec-3bf7491df6572024-12-18WarningsExact identifier
application number: M020
Costa Sea Mineral Sunscreen SPF 50ZINC OXIDECOSTA SEA INC841e1b3d-dbbc-4bb0-886a-fb2d077ae7392024-12-18WarningsExact identifier
application number: M020
SPF 50 plus Sunscreen All Mineral Active IngredientsTITANIUM DIOXIDE AND ZINC OXIDEKAS Direct LLC dba BabyGanics247aae3d-1845-4dd8-b774-b9e8214809a22024-12-18WarningsExact identifier
application number: M020
Softlips Vanilla, Watermelon, CherryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company2235d029-157e-4a30-be90-605e6bc143fd2024-12-17WarningsExact identifier
application number: M020
Softlips Salted Caramel, Candy Apple, Marshmallow GhostDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company42cf4623-0eb8-455a-b374-8e17e9336b922024-12-17WarningsExact identifier
application number: M020
Softlips Peppermint Mocha, Apple Chai Cider, Orange CranberryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company0338c078-695d-4d4e-9e90-5a8a98d495242024-12-17WarningsExact identifier
application number: M020
Softlips Pearl Plus VanillaDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company107bcaa9-4347-4979-be44-35183a9ee67e2024-12-17WarningsExact identifier
application number: M020
Softlips RaspberryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companyd18b4c19-0365-44ec-bea8-4328e537e0d82024-12-17WarningsExact identifier
application number: M020
Softlips WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company03062f13-270d-49cf-8939-2349f12e9cba2024-12-17WarningsExact identifier
application number: M020
Softlips Vanilla WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companyf733747a-ad1a-4222-baf1-69dcd90a33502024-12-17WarningsExact identifier
application number: M020
Softlips Vanilla WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company1fbe85a2-4cd7-45bd-85a2-83bbf75c5f972024-12-17WarningsExact identifier
application number: M020
Softlips Marshmallow GhostDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company8d55141d-5d6f-4eec-87dc-d3c808cf7a6a2024-12-17WarningsExact identifier
application number: M020
Softlips PearlOCTINOXATE, OCTISALATEThe Mentholatum Company43e175b4-7a48-431e-bf27-9ce7dee53f5e2024-12-17WarningsExact identifier
application number: M020
Softlips Oasis Watermelon BlackberryDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Companye1213808-4dad-4fd0-871a-04bba094a3cc2024-12-17WarningsExact identifier
application number: M020
Softlips PeppermintDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb272024-12-17WarningsExact identifier
application number: M020
Softlips Oasis Pineapple Coconut, Peach Mango, Strawberry KiwiDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Company7c8a4921-ae45-47fb-a64e-c72b1a386d0d2024-12-17WarningsExact identifier
application number: M020
Mentholatum Medicated Lip Balm CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company6edb132d-bb67-4e6c-8e18-db0305073a712024-12-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60892-602-156089206021515 mL in 1 BOTTLE15 mlHistorical
60892-602-16608920602161 BOTTLE in 1 BOX (60892-602-16) / 15 mL in 1 BOTTLE (60892-602-15) 1 bottle2018-12-230000-00-00NoNoCurrent
60892-602-326089206023250 mL in 1 BOTTLE, PUMP50 mlHistorical
60892-602-33608920602331 BOTTLE, PUMP in 1 BOX (60892-602-33) / 50 mL in 1 BOTTLE, PUMP (60892-602-32) 2018-12-120000-00-00NoNoCurrent
60892-602-77608920602774 mL in 1 PACKET (60892-602-77) 4 ml2018-12-120000-00-00YesNoCurrent