FDA.reportPublic FDA data

Total Eye 3-In-1 Renewal Therapy SPF 35 (Deep)

Manufacturer
Colorescience
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:26:24

Label at a glance#

ProductTotal Eye 3-In-1 Renewal Therapy SPF 35
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure13 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. Works best on moisturized skin. Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Children under 6 months: ask a doctor. 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 measure...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Titanium Dioxide 7.9%Sunscreen
Zinc Oxide 6.7%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 on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.

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 liberally 15 minutes before sun exposure. Works best on moisturized skin.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Children under 6 months: ask a doctor.

Sun Protection Measures

SPL UNCLASSIFIED SECTION

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 a.m.– 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water, Hydrogenated Polyisobutene, Cyclopentasiloxane, Caprylic/Capric Triglyceride, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Glycerin, Panthenol, Mica, Dimethicone Crosspolymer, Albizia Julibrissin Bark Extract, Sea Water, Sorbitol, Jojoba Esters, Sodium Hyaluronate, Palmitoyl Tripeptide-5, Tremella Fuciformis Sporocarp Extract, Hydrolyzed Algin, Ascophyllum Nodosum Extract, Betaine, Dunaliella Salina Extract, Asparagopsis Armata Extract, Sucrose, Darutoside, Pantolactone, Tocopherol, Sodium Chloride, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Polyhydroxystearic Acid, Glyceryl Behenate/Eicosadioate, Dimethicone, Lauroyl Lysine, Dimethiconol, Ethylhexylglycerin, Triethoxycaprylylsilane, Alumina, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Citric Acid, Iron Oxides (CI 77491, CI 77492, CI 77499)

Other Information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 866.426.5673

SPL UNCLASSIFIED SECTION

Dist. in USA by colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

colorescience®

TOTAL
EYE®

3-IN-1 RENEWAL
THERAPY

  • Improves the
    appearance of:
    dark circles, fine
    lines & wrinkles
  • Brightens &
    depuffs

35
Broad Spectrum
SPF 35 Sunscreen
PA+++

ALL-MINERAL ACTIVES

0.23 fl. oz. / 7 mL

PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton

PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton - Fair

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

colorescience®

TOTAL
EYE®

3-IN-1 RENEWAL
THERAPY

  • Improves the
    appearance of:
    dark circles, fine
    lines & wrinkles
  • Brightens &
    depuffs

35
Broad Spectrum
SPF 35 Sunscreen
PA+++

ALL-MINERAL ACTIVES

0.23 fl. oz. / 7 mL

PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton - Fair
PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton - Fair

PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton - Tan

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

colorescience®

TOTAL
EYE®

3-IN-1 RENEWAL
THERAPY

  • Improves the
    appearance of:
    dark circles, fine
    lines & wrinkles
  • Brightens &
    depuffs

35
Broad Spectrum
SPF 35 Sunscreen
PA+++

ALL-MINERAL ACTIVES

0.23 fl. oz. / 7 mL

PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton - Tan
PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton - Tan

PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton - Deep

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

colorescience®

TOTAL
EYE®

3-IN-1 RENEWAL
THERAPY

  • Improves the
    appearance of:
    dark circles, fine
    lines & wrinkles
  • Brightens &
    depuffs

35
Broad Spectrum
SPF 35 Sunscreen
PA+++

ALL-MINERAL ACTIVES

0.23 fl. oz. / 7 mL

PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton - Deep
PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton - Deep

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
68078-024-012021-12-20C16284748780-1ba0f9c33-3813-a910-e053-dadaa90a0b85Total Eye™ 3-In-1 Renewal Therapy SPF 35
68078-024-022021-12-20C16284748780-1ba0f9c33-3813-a910-e053-dadaa90a0b85Total Eye™ 3-In-1 Renewal Therapy SPF 35
68078-024-012021-01-29C16284748780-1ba0f9c33-3813-a910-e053-dadaa90a0b85Total Eye™ 3-In-1 Renewal Therapy SPF 35
68078-024-022021-01-29C16284748780-1ba0f9c33-3813-a910-e053-dadaa90a0b85Total Eye™ 3-In-1 Renewal Therapy SPF 35

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68078-024-01Total Eye 3-In-1 Renewal Therapy SPF 357 mL in 1 TUBELIQUID76
68078-024-01Total Eye 3-In-1 Renewal Therapy SPF 351 in 1 CARTONLIQUID16
68078-024-02Total Eye 3-In-1 Renewal Therapy SPF 350.5 mL in 1 PACKETLIQUID0.56
68078-046-01Total Eye 3-In-1 Renewal Therapy SPF 35 (Fair)1 in 1 CARTONLIQUID16
68078-046-01Total Eye 3-In-1 Renewal Therapy SPF 35 (Fair)7 mL in 1 TUBELIQUID76
68078-047-01Total Eye 3-In-1 Renewal Therapy SPF 35 (Tan)7 mL in 1 TUBELIQUID76
68078-047-01Total Eye 3-In-1 Renewal Therapy SPF 35 (Tan)1 in 1 CARTONLIQUID16
68078-048-01Total Eye 3-In-1 Renewal Therapy SPF 35 (Deep)7 mL in 1 TUBELIQUID76
68078-048-01Total Eye 3-In-1 Renewal Therapy SPF 35 (Deep)1 in 1 CARTONLIQUID16

Products#

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

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68078-02468078-024-01, 68078-024-02
68078-04668078-046-01
68078-04768078-047-01
68078-04868078-048-01

Ingredients#

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

DailyMed ingredient rows page 1 of 5 · 169 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
HYDROGENATED POLYISOBUTENE (1300 MW)7D1YQ9Y5EZIACT
CYCLOMETHICONE 50THT5PCI0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
PANTHENOLWV9CM0O67ZIACT
MICAV8A1AW0880IACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
ALBIZIA JULIBRISSIN BARK0J9G6W44DVIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PALMITOYL TRIPEPTIDE-52A3916MQHOIACT
ASCOPHYLLUM NODOSUM168S4EO8YJIACT
BETAINE3SCV180C9WIACT
DUNALIELLA SALINAF4O1DKI9A6IACT
ASPARAGOPSIS ARMATA2936KN6I1GIACT
SUCROSEC151H8M554IACT
DARUTOSIDEEG8ODI0780IACT
TOCOPHEROLR0ZB2556P8IACT
SODIUM CHLORIDE451W47IQ8XIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
GLYCERYL BEHENATE/EICOSADIOATE73CJJ317SRIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
LAUROYL LYSINE113171Q70BIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ALUMINUM OXIDELMI26O6933IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PENTYLENE GLYCOL50C1307PZGIACT
HYDROGENATED STARCH HYDROLYSATE27F77DSJ5VIACT
LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)H49Q67JS3BIACT
TREMELLA FUCIFORMIS FRUITING BODYGG8N28393GIACT
FERRIC OXIDE RED1K09F3G675IACT

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
Total Eye 3-In-1 Renewal Therapy SPF 35TITANIUM DIOXIDE AND ZINC OXIDEColorescience4b116cc4-94d2-4bfc-b7f9-5f486a194c6c2025-12-16WarningsExact identifier
ndc (package): 68078-047-01
ndc (package): 68078-024-02
ndc (package): 68078-024-01
ndc (package): 68078-046-01
ndc (package): 68078-048-01
ndc (product): 68078-046
ndc (product): 68078-047
ndc (product): 68078-024
ndc (product): 68078-048
ndc11 (package): 68078002402
ndc11 (package): 68078002401
ndc11 (package): 68078004801
ndc11 (package): 68078004601
ndc11 (package): 68078004701
spl id: 9f51cd1f-3c72-44f7-aea4-61bdf449737b
spl set id: 4b116cc4-94d2-4bfc-b7f9-5f486a194c6c

Reported adverse events (FAERS/openFDA)#

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