FDA.reportPublic FDA data

Total Eye 3-In-1 Renewal Therapy SPF 35

Product NDC
68078-024
11-digit product format
680780024
Labeler code
68078
Product ID
68078-024_9f51cd1f-3c72-44f7-aea4-61bdf449737b
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc Oxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
Colorescience
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-19
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
79; 67 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Total Eye 3-In-1 Renewal Therapy SPF 35
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE79 mg/mL
ZINC OXIDE67 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b116cc4-94d2-4bfc-b7f9-5f486a194c6cAvailable on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68078-024-012021-12-20Total Eye™ 3-In-1 Renewal Therapy SPF 35
68078-024-022021-12-20Total Eye™ 3-In-1 Renewal Therapy SPF 35
68078-024-012021-01-29Total Eye™ 3-In-1 Renewal Therapy SPF 35
68078-024-022021-01-29Total 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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68078-024TOTAL EYE 3-IN-1 RENEWAL THERAPY SPF 35 (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID TOTAL EYE 3-IN-1 RENEWAL THERAPY SPF 35 (FAIR) (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID TOTAL EYE 3-IN-1 RENEWAL THERAPY SPF 35 (TAN) (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID TOTAL EYE 3-IN-1 RENEWAL THERAPY SPF 35 (DEEP) (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID [COLORESCIENCE]4Current NDC, Legacy NDC, 3 package rows20231216_4b116cc4-94d2-4bfc-b7f9-5f486a194c6c.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 85 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
100% Mineral Broad Spectrum Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDESupergoop LLCd6fcc065-cbcd-0b81-e053-2a95a90ab1f92026-01-09WarningsExact identifier
application number: M020
Glow Screen Body Broad Spectrum Sunscreen SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCb9590938-417d-617a-e053-2995a90a74962026-01-09WarningsExact identifier
application number: M020
100% Mineral Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDESupergoop LLCd7758651-c152-5868-e053-2a95a90ab6732026-01-09WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 30ZINC OXIDESupergoop, LLC4cf243b4-d794-401a-b209-18c7e550ef4f2026-01-09WarningsExact identifier
application number: M020
Daily Dose Bioretinol Mineral SPF 40ZINC OXIDESupergoop, LLCeb5bbc70-dbdf-06a8-e053-2995a90a66c12026-01-09WarningsExact identifier
application number: M020
Unseen Sunscreen Body SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCec1c30bd-76e1-9d00-e053-2a95a90a17592026-01-09WarningsExact identifier
application number: M020
Glow Screen SPF 40AVOBENZONE, OCTISALATE, OCTOCYLENESupergoop, LLC21569637-332a-461b-bf6c-33af6a83a1552026-01-09WarningsExact identifier
application number: M020
Glowscreen SPF 40 - DawnAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCf07145d5-b74d-7757-e053-2a95a90ac4c02026-01-09WarningsExact identifier
application number: M020
Glowscreen SPF 40 -SunsetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCf7e493da-8fc6-191d-e053-6294a90aa4832026-01-09WarningsExact identifier
application number: M020
Supergoop Glow Screen SPF 40 Shade 2 Golden HourBROAD SPECTRUM SUNSCREENSupergoop LLCd2928dd7-a813-4929-e053-2a95a90aaeb42026-01-09WarningsExact identifier
application number: M020
Superscreen Hydrating Daily Cream SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCff0e4e97-8f01-bd36-e053-6394a90a47ae2026-01-09WarningsExact identifier
application number: M020
Lipshade SPF 30 Hey YallZINC OXIDESupergoop, LLCf93dfa13-ff18-ee38-e053-6394a90aea462026-01-09WarningsExact identifier
application number: M020
Triple Prep SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATESupergoop, LLC004df4e5-dba9-6030-e063-6394a90a76d32026-01-09WarningsExact identifier
application number: M020
Unseen Sunscreen Lip Protector SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC12605fb4-0de6-94f3-e063-6294a90a3a6f2026-01-09WarningsExact identifier
application number: M020
Unseen Sunscreen Stick SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC2735c5c7-a4ef-33c3-e063-6294a90abf972026-01-09WarningsExact identifier
application number: M020
PLAY Sunscreen SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONESupergoop LLC2860d42c-d644-8b5a-e063-6394a90aec102026-01-09WarningsExact identifier
application number: M020
PLAY Mineral SPF 30 with Green AlgaeZINC OXIDESupergoop LLC29a1ff4b-3875-5275-e063-6394a90a53fd2026-01-09WarningsExact identifier
application number: M020
Every. Single. Face. Watery SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCd086a9b8-19e5-f713-e053-2995a90aa9762026-01-09WarningsExact identifier
application number: M020
3D Tinted Moisturizing BS SPF 30ZINC OXIDEAllure Labs47fd415f-819e-bbb8-e063-6394a90a2c6a2026-01-09WarningsExact identifier
application number: M020
ST MORIZ SUNCARE BODY SUNSCREEN SPF50SUNCARE BODY SUNSCREEN SPF50Aopline Biotechnology (Guangzhou) Co., Ltd.4801cfd2-1fe2-d118-e063-6294a90a6c8b2026-01-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68078-024-01680780024011 TUBE in 1 CARTON (68078-024-01) / 7 mL in 1 TUBE1 tube2018-01-190000-00-00NoNoCurrent
68078-024-0268078002402.5 mL in 1 PACKET (68078-024-02) 2018-01-190000-00-00NoNoCurrent