Total Eye 3-In-1 Renewal Therapy SPF 35

Product NDC: 68078-024
Requested package NDC: 68078-024-01
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
Ingredient	Strength
TITANIUM DIOXIDE	79 mg/mL
ZINC OXIDE	67 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
15FIX9V2JP	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
4b116cc4-94d2-4bfc-b7f9-5f486a194c6c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1c9d1af-bddd-448d-86f7-69052b7d5b47	Product name	1	20220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68078-024-01	2021-12-20	Total Eye™ 3-In-1 Renewal Therapy SPF 35
68078-024-02	2021-12-20	Total Eye™ 3-In-1 Renewal Therapy SPF 35
68078-024-01	2021-01-29	Total Eye™ 3-In-1 Renewal Therapy SPF 35
68078-024-02	2021-01-29	Total Eye™ 3-In-1 Renewal Therapy SPF 35

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68078-024-01	Total Eye 3-In-1 Renewal Therapy SPF 35	7 mL in 1 TUBE	LIQUID	7	6
68078-024-01	Total Eye 3-In-1 Renewal Therapy SPF 35	1 in 1 CARTON	LIQUID	1	6
68078-024-02	Total Eye 3-In-1 Renewal Therapy SPF 35	0.5 mL in 1 PACKET	LIQUID	0.5	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68078-024	TOTAL 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]	4	Current NDC, Legacy NDC, 3 package rows	20231216_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 113 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
UV Defense Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC	365e09a8-308b-b753-e063-6394a90ae9e5	2025-12-16		Exact identifier application number: M020
UV Defense Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	CCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC	365e2498-7df2-f22c-e063-6294a90ac6ab	2025-12-16		Exact identifier application number: M020
UV Protection Veil Mineral Sunscreen non tinted	TITANIUM DIOXIDE, ZINC OXIDE	ATHENA PLASTIC SURGERY	3b3bf5a6-33ec-0255-e063-6294a90ac96a	2025-12-16	Warnings	Exact identifier application number: M020
UV Protection Veil Mineral Sunscreen, tinted	TITANIUM DIOXIDE, ZINC OXIDE	ATHENA PLASTIC SURGERY	3b3cba2e-acc6-a2df-e063-6294a90abf71	2025-12-16	Warnings	Exact identifier application number: M020
Color Smart Tinted Mineral	ZINC OXIDE	MEGAN YORK INC.	365c4623-94d5-e8b6-e063-6394a90a966a	2025-12-16		Exact identifier application number: M020
Anti-Aging Tinted Sunscreen	ZINC OXIDE	KARINA SALDIVAR	3bca508e-7bd0-d45d-e063-6394a90a1730	2025-12-16	Warnings	Exact identifier application number: M020
UV Protection Veil Mineral Sunscreen, tinted	TITANIUM DIOXIDE, ZINC OXIDE	ATHENA PLASTIC SURGERY	3b3c757f-6581-4978-e063-6294a90a6173	2025-12-16	Warnings	Exact identifier application number: M020
Kind Restore Tinted Mineral Sunscreen	ZINC OXIDE	POLISH BEAUTY	3980810f-58b5-3a60-e063-6294a90a9c07	2025-12-16		Exact identifier application number: M020
Daydream Beyond Screen	ZINC OXIDE	ULTRAVIOLET SKINCARE LLC	36bfd963-d123-0d25-e063-6294a90aa827	2025-12-16		Exact identifier application number: M020
Virgo SOL Primer Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ULTRAVIOLET SKINCARE LLC	369d4f43-8c57-9fcf-e063-6294a90aa916	2025-12-16		Exact identifier application number: M020
Virgo SOL Non Tinted Mousse	TITANIUM DIOXIDE, ZINC OXIDE	ULTRAVIOLET SKINCARE LLC	369d63a9-b9ab-9530-e063-6394a90ac8ef	2025-12-16		Exact identifier application number: M020
Kind Restore Tinted Mineral Sunscreen	ZINC OXIDE	POLISH BEAUTY	3980d278-c0f4-2c59-e063-6394a90aac37	2025-12-16		Exact identifier application number: M020
Solar Eclipse Extreme Sunscreen	ZINC OXIDE	ULTRAVIOLET SKINCARE LLC	36bfa691-48c0-8033-e063-6294a90ad899	2025-12-16		Exact identifier application number: M020
Kind Restore Moisturizing Lip Balm	TITANIUM DIOXIDE, ZINC OXIDE	POLISH BEAUTY	39814e27-4f3f-5ee6-e063-6394a90a941b	2025-12-16		Exact identifier application number: M020
Yoali SPF 40	ZINC OXIDE	YOALI STUDIO LLC	390b7f9c-bc04-80ec-e063-6294a90a4092	2025-12-16		Exact identifier application number: M020
Skin Defense Matte Tinted Sunscreen	ZINC OXIDE	Gentlehomme LLC	365eb727-3e7f-f1dd-e063-6394a90aa469	2025-12-16		Exact identifier application number: M020
Dr B Clinical Skin Care Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	NAIRA BABAIAN, M.D., P.A.	365da1f8-5250-7589-e063-6294a90a3e68	2025-12-16		Exact identifier application number: M020
Dr B Clinical Skin Care Non Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	NAIRA BABAIAN, M.D., P.A.	365d7564-3025-257b-e063-6294a90ad170	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	ZINC OXIDE	Gentlehomme LLC	365e7d8e-e3e0-4c08-e063-6294a90af415	2025-12-16		Exact identifier application number: M020
Daily Replenish mineral sunscreen	ZINC OXIDE	PURE VITALITY SKIN AND BODY, INC	369896b1-f4b4-6201-e063-6394a90a5bca	2025-12-16		Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68078-024-01	68078002401	1 TUBE in 1 CARTON (68078-024-01) / 7 mL in 1 TUBE	1 tube	2018-01-19	0000-00-00	No	No	Current