FDA.reportPublic FDA data

TriLipiderm

Manufacturer
TriLipid Research Institute, LLC
Effective date
2025-11-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:43:09

Label at a glance#

ProductTriLipiderm Protective Day
Active ingredientOCTINOXATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure12 sections

Indications and uses

Helps Prevent Sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months: ask a doctor Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures includ...

Storage and handling

Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10%, Ethylhexyl Methoxycinnamate 7.5%, Butyl Methoxydibenzoylmethane 3%, Octocrylene 2.7%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps Prevent Sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

When using this product

OTC - WHEN USING SECTION

Keep out of eyes. Rinse with water to remove

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10:00 AM – 2:00 PM
  • Wear long sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua (Deionized Water), I-Arginine, Ascorbic Acid (Vitamin C), Benzoic Acid, Cetearyl Alcohol, Chamomilla Matricaria (Chamomile) Extract, Cholecalciferol (Vitamin D3), Crambe Abyssinica (Abyssinian) 0il, Ethylhexylglycerin, Gluconolactone, Glycerin, Glyceryl Stearate, Limnanthes Alba (Meadowfoam) Seed Oil, Olea Europaea (Olive) Fruit Unsaponifiables, Phenoxyethanol, Polysorbate-20, Polysorbate-60, Retinyl Palmitate (Vitamin A), Sodium Hyaluronate, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hydroxide, Squalane, Tocopheryl Acetate (Vitamin E)

Other Information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun

TriLipiderm Protective Day Creme

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sample ImageSample Image

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60892-602-162023-10-09C16284748780-1d6a99b39-b5a4-a426-e053-dadaa90af4c2TriLipiderm Protective Day Creme
60892-602-162023-10-09C16284748780-1d6a99b39-b5a4-a426-e053-dadaa90af4c2TriLipiderm Protective Day Creme
60892-602-332023-10-09C16284748780-1d6a99b39-b5a4-a426-e053-dadaa90af4c2TriLipiderm Protective Day Creme
60892-602-332023-10-09C16284748780-1d6a99b39-b5a4-a426-e053-dadaa90af4c2TriLipiderm Protective Day Creme
60892-602-772023-10-09C16284748780-1d6a99b39-b5a4-a426-e053-dadaa90af4c2TriLipiderm Protective Day Creme
60892-602-772023-10-09C16284748780-1d6a99b39-b5a4-a426-e053-dadaa90af4c2TriLipiderm Protective Day Creme
60892-602-162022-01-28C16284748780-1d6a99b39-b5a4-a426-e053-dadaa90af4c2TriLipiderm Protective Day Creme
60892-602-162022-01-28C16284748780-1d6a99b39-b5a4-a426-e053-dadaa90af4c2TriLipiderm Protective Day Creme
60892-602-332022-01-28C16284748780-1d6a99b39-b5a4-a426-e053-dadaa90af4c2TriLipiderm Protective Day Creme
60892-602-332022-01-28C16284748780-1d6a99b39-b5a4-a426-e053-dadaa90af4c2TriLipiderm Protective Day Creme
60892-602-772022-01-28C16284748780-1d6a99b39-b5a4-a426-e053-dadaa90af4c2TriLipiderm Protective Day Creme
60892-602-772022-01-28C16284748780-1d6a99b39-b5a4-a426-e053-dadaa90af4c2TriLipiderm 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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60892-60260892-602-32, 60892-602-33, 60892-602-77, 60892-602-15, 60892-602-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
CRAMBE HISPANICA SUBSP. ABYSSINICA WHOLE3885PD1IZ8IACT
GLUCONOLACTONEWQ29KQ9POTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SQUALANEGW89575KF9IACT
SODIUM HYDROXIDE55X04QC32IIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
OCTINOXATE4Y5P7MUD51ACTIB
CHOLECALCIFEROL1C6V77QF41IACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLESXO45V955LTIACT
POLYSORBATE 60CAL22UVI4MIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
BENZOIC ACID8SKN0B0MIMIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 207T1F30V5YHIACT
CHAMOMILEFGL3685T2XIACT
VITAMIN A81G40H8B0TIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
WATER059QF0KO0RIACT
ARGININE94ZLA3W45FIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-11-12full-release2026-06-01 00:37:09

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TriLipiderm Protective DayHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE,BUTYL METHOXYDIBENZOYLMETHANE, OCTOCRYLENETriLipid Research Institute, LLC66726c2b-27e9-5dd1-e053-2991aa0a1ba72025-11-10WarningsExact identifier
ndc (package): 60892-602-16
ndc (package): 60892-602-33
ndc (package): 60892-602-77
ndc (package): 60892-602-32
ndc (package): 60892-602-15
ndc (product): 60892-602
ndc11 (package): 60892060216
ndc11 (package): 60892060215
ndc11 (package): 60892060232
ndc11 (package): 60892060277
ndc11 (package): 60892060233
spl id: 43466aba-a567-fa52-e063-6394a90a41a9
spl set id: 66726c2b-27e9-5dd1-e053-2991aa0a1ba7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.