Total Eye Care

Manufacturer
Dermalogica | PakLab | Diamond Wipes
Effective date
2013-12-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:37:56

Label at a glance#

ProductTotal Eye Care SPF 15
Active ingredientTitanium Dioxide
Label structure9 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), may decrease the risk of skin cancer and early skin aging caused by the sun.

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 After cleansing in the morning, gently pat around the entire eye area, blending inward from the outer corner.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide (4.5%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), may decrease the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on broken or damaged skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

If irritation develops, discontinue use.

OTC - DO NOT USE SECTION

Do not use on infants under 6 months old.

OTC - STOP USE SECTION

Stop use and ask a physician if too much skin irritation or sensitivity develops or increases.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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
  • After cleansing in the morning, gently pat around the entire eye area, blending inward from the outer corner.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), C12-15 Alkyl Ethylhexanoate, Butylene Glycol, Glycerin, Silica, Lactic Acid, Cetearyl Alcohol, Potassium Cetyl Phosphate, Magnesium Aluminum Silicate, Glyceryl Stearate, PEG-100 Stearate, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Spiraea Ulmaria Flower Extract, Centella Asiatica Extract, Taurine, Leucine, Valine, Tyrosine, Arginine, Lysine, Sodium PCA, Tocopheryl Acetate, Bisabolol, Lauric Acid, Aluminum Hydroxide, Allantoin, Ceteareth-20, Xanthan Gum, Sodium Hydroxide, Propylene Glycol, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Talc, Iron Oxides (CI 77492, CI 77491), Mica (CI 77019).

Questions?

OTC - QUESTIONS SECTION

1-800-831-5150 in USA

PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

total
eye
care

spf
15
broad
spectrum

NPN #80011194
0.5 US Fl. Oz.
15 mL e

dermalogica®

Principal Display Panel - 15 mL Tube Carton
Principal Display Panel - 15 mL Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68479-360-002020-01-31C16284748780-19d75b9d0-1db3-f424-e053-dadaa90a57ceTotal Eye Care SPF 15
68479-360-012020-01-31C16284748780-19d75b9d0-1db3-f424-e053-dadaa90a57ceTotal Eye Care SPF 15
68479-360-022020-01-31C16284748780-19d75b9d0-1db3-f424-e053-dadaa90a57ceTotal Eye Care SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68479-360-00Total Eye Care SPF 152 mL in 1 POUCHLOTION21
68479-360-01Total Eye Care SPF 154 mL in 1 TUBELOTION41
68479-360-02Total Eye Care SPF 151 in 1 CARTONLOTION11
68479-360-02Total Eye Care SPF 1515 mL in 1 TUBELOTION151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68479-360TOTAL EYE CARE SPF 15 (TITANIUM DIOXIDE) LOTION [DERMALOGICA]1Legacy NDC, 4 package rows20131230_66f53ef8-03e7-48da-9365-02832e08b08f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
Titanium DioxideACTIVE MOIETY15FIX9V2JP1
.Alpha.-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L01
AllantoinINACTIVE INGREDIENT344S277G0Z1
Aluminum HydroxideINACTIVE INGREDIENT5QB0T2IUN01
ArginineINACTIVE INGREDIENT94ZLA3W45F1
BARIUM CARBONATEINACTIVE INGREDIENT6P669D8HQ81
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA1
Centella AsiaticaINACTIVE INGREDIENT7M867G6T1U1
Cetostearyl AlcoholINACTIVE INGREDIENT2DMT128M1S1
Citrus Aurantium FlowerINACTIVE INGREDIENTO730ZX2Z831
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K1
EthylhexylglycerinINACTIVE INGREDIENT147D247K3P1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
Filipendula Ulmaria FlowerINACTIVE INGREDIENT06L18L32G61
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE41
Lactic AcidINACTIVE INGREDIENT33X04XA5AT1
Lauric AcidINACTIVE INGREDIENT1160N9NU9U1
LeucineINACTIVE INGREDIENTGMW67QNF9C1
LevomenolINACTIVE INGREDIENT24WE03BX2T1
LysineINACTIVE INGREDIENTK3Z4F929H61
Magnesium Aluminum SilicateINACTIVE INGREDIENT6M3P64V0NC1
PEG-100 StearateINACTIVE INGREDIENTYD01N1999R1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Polyoxyl 20 Cetostearyl EtherINACTIVE INGREDIENTYRC528SWUY1
Potassium Cetyl PhosphateINACTIVE INGREDIENT03KCY6P7UT1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU41
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I1
Sodium Pyrrolidone CarboxylateINACTIVE INGREDIENT469OTG57A21
TalcINACTIVE INGREDIENT7SEV7J4R1U1
TaurineINACTIVE INGREDIENT1EQV5MLY3D1
TyrosineINACTIVE INGREDIENT42HK56048U1
ValineINACTIVE INGREDIENTHG18B9YRS71
WaterINACTIVE INGREDIENT059QF0KO0R1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68479-36068479-360-02, 68479-360-01, 68479-360-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 12 · 673 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii candidate
21 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KDROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / RECTALNAExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVENOUS456 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED / ORAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR0.35 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTFILM / BUCCAL0.27 mgExact identifier — unii candidate
20 equally ranked IID candidates
LeucineLEUCINEGMW67QNF9CINJECTION, SOLUTION / INTRAVENOUS0.27 %w/vExact identifier — unii candidate
4 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / DENTALNAExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Polyoxyl 20 Cetostearyl EtherPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYGEL / TOPICAL2 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IPOWDER, FOR SUSPENSION / ORAL9 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISPRAY, METERED / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / URETHRALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / RECTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / SOFT TISSUEADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ArginineARGININE94ZLA3W45FPOWDER, FOR SOLUTION / INTRAVENOUS7.07 %w/vExact identifier — unii candidate
11 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE, DELAYED RELEASE / ORAL3.2 mgExact identifier — unii candidate
49 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TalcTALC7SEV7J4R1UPOWDER, FOR SUSPENSION / ORAL735 mgExact identifier — unii candidate
35 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRASPINALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IOINTMENT / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Magnesium Aluminum SilicateMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCREAM / TOPICAL3 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Polyoxyl 20 Cetostearyl EtherPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYAEROSOL, FOAM / TOPICAL374 mgExact identifier — unii candidate
7 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATAEROSOL, FOAM / TOPICAL11 mgExact identifier — unii candidate
18 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-AMNIOTICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / OPHTHALMIC6 mgExact identifier — unii candidate
174 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
Magnesium Aluminum SilicateMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSYRUP / ORAL100 mg/1mlExact identifier — unii candidate
17 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSHAMPOO / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISWAB / TOPICAL0.01 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARYADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
Magnesium Aluminum SilicateMAGNESIUM ALUMINUM SILICATE6M3P64V0NCLOTION / TOPICAL1.5 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET / SUBLINGUAL1.23 mgExact identifier — unii candidate
21 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCAPSULE / ORAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KENEMA / RECTAL60 mgExact identifier — unii candidate
77 equally ranked IID candidates

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
8296bbf4-b9ea-4037-ab3c-9a945857518866f53ef8-03e7-48da-9365-02832e08b08f2013-12-23WarningsExact identifier
spl id: 8296bbf4-b9ea-4037-ab3c-9a9458575188
spl set id: 66f53ef8-03e7-48da-9365-02832e08b08f

Reported adverse events (FAERS/openFDA)#

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