FDA.reportPublic FDA data

Total Eye Care

Manufacturer
Dermalogica, Inc. | Thibiant | Diamond Wipes
Effective date
2017-12-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:46

Label at a glance#

ProductTotal Eye Care SPF 15
Active ingredientTitanium Dioxide
Label structure10 sections

Dosage and administration

Apply evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and take other sun protection measures including: - Limit time in the sun, espec...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide (5.0%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), helps decrease 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.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash occurs.

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 evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Sun Protection Measures.
    Spending time in the sun increases your risk of skin cancer and early skin aging. To help decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and take other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m. – 2 p.m.
    • Wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months: ask a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, C12-15 Alkyl Ethylhexanoate, Glycerin, Butylene Glycol, Silica, Thermus Thermophillus Ferment, Lactic Acid, Potassium Cetyl Phosphate, Cetearyl Alcohol, Betaine, Glyceryl Stearate SE, Magnesium Aluminum Silicate, PEG-100 Stearate, Saccharomyces Cerevisiae Extract, Rhodiola Rosea Root Extract, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Bisabolol, Allantoin, Sodium PCA, Tocopheryl Acetate, Xanthan Gum, Dimethicone, Triethoxycaprylylsilane, Tocopherol, Ceteareth-20, Sodium Hydroxide, Silica Dimethyl Silylate, Tetrasodium Glutamate Diacetate, Salicylic Acid, Potassium Sorbate, Ethylhexylglycerin, Benzyl Alcohol, Linalool, Limonene, Mica, Phenoxyethanol, Iron Oxides (CI 77492, CI 77491).

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-831-5150 in the US

PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

total
eye
care

spf
15
broad
spectrum

dermalogica®

0.5 US FL OZ
15 mL e

PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68479-608-002022-07-29C16284748780-1e4f33bdf-a00c-d8a0-e053-dadaa90a6e4eTotal Eye Care
68479-608-012022-07-29C16284748780-1e4f33bdf-a00c-d8a0-e053-dadaa90a6e4eTotal Eye Care
68479-608-022022-07-29C16284748780-1e4f33bdf-a00c-d8a0-e053-dadaa90a6e4eTotal Eye Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68479-608-00Total Eye CareSPF 152 mL in 1 POUCHLOTION21
68479-608-01Total Eye CareSPF 154 mL in 1 TUBELOTION41
68479-608-02Total Eye CareSPF 1515 mL in 1 TUBELOTION151
68479-608-02Total Eye CareSPF 151 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68479-608TOTAL EYE CARE SPF 15 (TITANIUM DIOXIDE) LOTION [DERMALOGICA, INC.]1Legacy NDC, 4 package rows20180301_8de23745-a2c5-4e82-a73a-dd3fcc1799bd.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68479-60868479-608-02, 68479-608-01, 68479-608-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Water059QF0KO0RIACT
C12-15 Alkyl EthylhexanoateGQJ580CH83IACT
GlycerinPDC6A3C0OXIACT
Butylene Glycol3XUS85K0RAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
THERMUS THERMOPHILUS LYSATE775R692494IACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
Potassium Cetyl Phosphate03KCY6P7UTIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
Betaine3SCV180C9WIACT
Glyceryl Stearate SEFCZ5MH785IIACT
Magnesium Aluminum Silicate6M3P64V0NCIACT
PEG-100 StearateYD01N1999RIACT
SACCHAROMYCES CEREVISIAE978D8U419HIACT
SEDUM ROSEUM ROOT3S5ITS5ULNIACT
LEVOMENOL24WE03BX2TIACT
Allantoin344S277G0ZIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
Xanthan GumTTV12P4NEEIACT
Dimethicone92RU3N3Y1OIACT
TriethoxycaprylylsilaneLDC331P08EIACT
TocopherolR0ZB2556P8IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
Sodium Hydroxide55X04QC32IIACT
Silica Dimethyl SilylateEU2PSP0G0WIACT
Tetrasodium Glutamate Diacetate5EHL50I4MYIACT
Salicylic AcidO414PZ4LPZIACT
Potassium Sorbate1VPU26JZZ4IACT
Ethylhexylglycerin147D247K3PIACT
LINALOOL, (+/-)-D81QY6I88EIACT
LIMONENE, (+)-GFD7C86Q1WIACT
MicaV8A1AW0880IACT
PhenoxyethanolHIE492ZZ3TIACT
FERROUS OXIDEG7036X8B5HIACT

Source Document#

Source XML · Source PDF

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
d67c5464-4878-40f1-af9a-2eb39649fc848de23745-a2c5-4e82-a73a-dd3fcc1799bd2017-12-29WarningsExact identifier
spl id: d67c5464-4878-40f1-af9a-2eb39649fc84
spl set id: 8de23745-a2c5-4e82-a73a-dd3fcc1799bd

Reported adverse events (FAERS/openFDA)#

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