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 266 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arbonne AgeWell Moisture Restoring Broad Spectrum SPF 15 SunscreenZINC OXIDEArbonne International, LLCc172f793-3f7a-47b3-9db1-58487b8ad66c2024-11-12WarningsExact identifier
application number: M020
Hello Sunday The Everyday One Face Moisturiser SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c7e1aa2-7054-435d-e063-6394a90a2d082024-11-12WarningsExact identifier
application number: M020
ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45ZINC OXIDEZO Skin Health, Inc.be3c7ef2-dd08-0f1a-e053-2995a90ae14c2024-11-12WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish - TintedZINC OXIDEFallien Cosmeceuticals, LTDfbafa468-fce0-4597-bcb0-a816dc71ec7c2024-11-12WarningsExact identifier
application number: M020
Sunscreen Plus Powder Broad-Spectrum SPF 45ZINC OXIDEZO Skin Health, Inc.beb0b43b-a90d-05ae-e053-2995a90a1d8e2024-11-12WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Anti-Aging Perfector Sunscreen Broad Spectrum SPF 20 Ivory to Fair 10OCTINOXATE AND OCTISALATEKenvue Brands LLC0e489dec-9c7e-48c1-98cb-1aec91884a162024-11-11WarningsExact identifier
application number: M020
Neutrogena Revitalizing Lip Balm SPF 20 - Sheeer Shimmer 10OCTINOXATE AND OXYBENZONEKenvue Brands LLCe77c07d4-4e64-4000-9e7a-963aa6c6448c2024-11-11WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc DRY-TOUCH Sunscreen Broad Spectrum SPF50ZINC OXIDEKenvue Brands LLC54a3b677-4510-4191-8386-ccdd10ccfcaa2024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior504d8118-f84d-4f3f-abd1-463f3780a2cb2024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior0d4e667a-cf93-4f6d-8565-ecfa9a18cfbf2024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorcb1d643e-34dc-48f2-aecd-ba2a35dc34032024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior097b3d7b-5dff-4206-99f1-6573902232e92024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4WOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora621a610-7dd2-4ccd-bc48-8671e4f4a8872024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior43296d42-7bc2-4073-8231-4a7921f9ebe32024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5ee35643-bd86-4d55-914a-96f4670bfd072024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf519aa3f-11a1-4941-bf31-47ac11f5a7032024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior03f0ad8b-25b1-4b01-abad-d1b0851e15c52024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3CROCTISALATE, TITANIUM DIOXIDEParfums Christian Diora6363bc5-6a99-4412-ba62-ec66054e2c712024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior9b2133dd-5dd0-476d-98c7-7f2e72024de72024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5b74e312-39b1-4b11-a678-b4fccea845812024-11-11WarningsExact 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