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
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 239 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	PURA VIDA BODY & MIND SPA, INC.	04b38e97-c4b3-df23-e063-6394a90ae6b7	2025-01-08	Warnings	Exact identifier application number: M020
EVEN DEFENSE Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Premier Plastic Surgery	bc9221fe-89b4-4ad8-e053-2995a90aa041	2025-01-08	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Emerald Aesthetics LLC	f80f439d-f4f0-fbf3-e053-6294a90ae0ef	2025-01-08	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Suzanne's Skin2soul LLC	fea667a1-6bec-9819-e053-6394a90a9b96	2025-01-08	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	BEAUTY SENSE MEDSPA INC	fe93a337-8d2f-35d3-e053-6294a90acb3c	2025-01-08	Warnings	Exact identifier application number: M020
Sunscreen Emulsion SPF50plus	OCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATE	Guangzhou Senmai Biotechnology Co.	1d560670-026b-bd34-e063-6394a90a9af4	2025-01-08	Warnings	Exact identifier application number: M020
Allies of Skin Sunless Tan SPF 50 Daily Self Tanner	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	ALLIES GROUP PTE. LTD.	4d58de8e-875b-4b77-b0ef-b9d760aaced8	2025-01-07	Warnings	Exact identifier application number: M020
Pop Zinc Sunscreen	ZINC OXIDE	Guangzhou Haishi Biological Technology Co., Ltd	2b29ddb2-5730-8a67-e063-6394a90ae416	2025-01-07	Warnings	Exact identifier application number: M020
COOLA Anti-Aging Sun Silk Drops Sunscreen SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUM	COOLA LLC	bbb29d0c-ae1f-409e-8fd6-ff3ea34dc9c2	2025-01-07	Warnings	Exact identifier application number: M020
Advanced Day Ultimate Protect Sunscreen SPF 50	BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE	Medik8 Limited	29071920-ba90-871a-e063-6294a90aee27	2025-01-06	Warnings	Exact identifier application number: M020
Dimples Bath Co - Sunstick New Kid On The Block	ZINC OXIDE	Dimples Bath Co. LLC	26f682f4-2440-f111-e063-6294a90ab4b7	2025-01-06	Warnings	Exact identifier application number: M020
Diaper Rash Cream Happy Cheeks	DIAPER RASH HAPPY CHEEKS	Dimples Bath Co. LLC	26cef2eb-a133-11ec-e063-6394a90a0f08	2025-01-06	Warnings	Exact identifier application number: M020
New Kid on the Block	ZINC OXIDE	Dimples Bath Co. LLC	26fec959-c234-6692-e063-6394a90a6600	2025-01-06	Warnings	Exact identifier application number: M020
New Kid on the Block	ZINC OXIDE	Dimples Bath Co. LLC	26f85758-820f-3f73-e063-6294a90a289d	2025-01-06	Warnings	Exact identifier application number: M020
Bondi Sands SPF 60 Sunny Spritz Face Mist	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	BONDI SANDS (USA) INC.	2b0f0b56-233f-4c6a-e063-6394a90aea6f	2025-01-06	Warnings	Exact identifier application number: M020
Bondi Sands SPF 60 Sunny Spritz Body Mist	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	BONDI SANDS (USA) INC.	2b0fe721-b92a-4181-e063-6394a90a846a	2025-01-06	Warnings	Exact identifier application number: M020
sunbetter Broad Spectrum SPF 56 Sunscreen Stick Sheer	ZINC OXIDE, TITANIUM DIOXIDE	SKINBETTER SCIENCE LLC	92c4e4cb-aadc-26f4-e053-2995a90a03d5	2025-01-06	Warnings	Exact identifier application number: M020
sunbetter Broad Spectrum SPF 56 Sunscreen Compact Sheer	ZINC OXIDE, TITANIUM DIOXIDE	SKINBETTER SCIENCE LLC	b8a4986d-c28f-c4f4-e053-2a95a90a7167	2025-01-06	Warnings	Exact identifier application number: M020
sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone Smart	ZINC OXIDE, TITANIUM DIOXIDE	SKINBETTER SCIENCE LLC	8f119447-045b-43f3-e053-2995a90aea77	2025-01-06	Warnings	Exact identifier application number: M020
sunbetter Broad Spectrum SPF 75 Sunscreen Tone Smart	ZINC OXIDE, TITANIUM DIOXIDE	SKINBETTER SCIENCE LLC	b878ee3b-6897-3c4a-e053-2995a90afed7	2025-01-06	Warnings	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
68078-024-02	68078002402	.5 mL in 1 PACKET (68078-024-02)		2018-01-19	0000-00-00	No	No	Current