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
15FIX9V2JP	Internal UNII lookup
SOI2LOH54Z	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 210 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rodan and Fields Reverse Brightening Defense Broad Spectrum SPF 50 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields Beauty, LLC	afa2d42e-b54d-4843-b313-0c44fe5c5d52	2025-06-06	Warnings	Exact identifier application number: M020
1000 Roses CC Color Plus Correct Sheer Tan SPF 30	ZINC OXIDE	Andalou naturals	9314e4fc-ba3e-480e-a005-b8928130ed70	2025-06-06	Warnings	Exact identifier application number: M020
Neutrogena Sheer Zinc Face Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	3169bf3b-a5a8-4c3e-a182-9f24f8ade3ac	2025-06-05	Warnings	Exact identifier application number: M020
Body Glove Sunscreen SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	SCUBASCREEN LLC	1d7a960c-4387-44dc-8d4e-881e21a8ae2e	2025-06-05	Warnings	Exact identifier application number: M020
Vacation Classic Mini Whip SPF 30 Broad Spectrum SPF 30	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Vacation Inc.	36d65cb2-c2e7-06d7-e063-6394a90a3822	2025-06-05	Warnings	Exact identifier application number: M020
Vacation Classic Whip SPF 50 Broad Spectrum SPF 50	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Vacation Inc.	36d747fb-b973-5611-e063-6394a90ac661	2025-06-05	Warnings	Exact identifier application number: M020
Non Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	BABYFACE LLC	36d7c8b3-554f-78d9-e063-6394a90a80f3	2025-06-05		Exact identifier application number: M020
Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	BABYFACE LLC	36d80422-943f-3aba-e063-6294a90afb59	2025-06-05		Exact identifier application number: M020
Mineral Creme SPF 50 Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	f8e178d6-058c-462a-8e59-6721f28ad040	2025-06-05	Warnings	Exact identifier application number: M020
Mineral Tinted SPF 30 Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	adcd6881-fa25-4312-95e5-5b47102aa6b9	2025-06-05	Warnings	Exact identifier application number: M020
Mineral Moisture Defense SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	05ad73f3-a4e8-4f78-8212-3e8e3bda988c	2025-06-05	Warnings	Exact identifier application number: M020
Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	6ce602bb-c1f4-43c1-ae61-0f05d7952db3	2025-06-05	Warnings	Exact identifier application number: M020
Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	b8f08778-7e5e-4341-9a24-1ce57c6525c7	2025-06-05	Warnings	Exact identifier application number: M020
Quick Dry Body Broad Spectrum SPF40 Sunscreen UVA-UVB Sunscreen with SolSci-X	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	MDSolarSciences	812caa99-1e1e-4ab8-9f9a-fb3384c684dd	2025-06-05	Warnings	Exact identifier application number: M020
MD Daily Perfecting Moisturizer SPF 30. SPF 30 Broad Spectrum Sunscreen UVA-UVB	AVOBENZONE, OCTOCRYLENE, AND OCTISALATE	MDSolarSciences	ba918886-d277-487a-be3b-bbe3e24343ad	2025-06-05	Warnings	Exact identifier application number: M020
Gleam plus Glow SPF 50. SPF 50 Broad Spectrum Sunscreen UVA-UVB Sheer Glow Tint	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	MDSolarSciences	3e392af6-1401-4a2f-9ba4-e43f0fd0fca1	2025-06-05	Warnings	Exact identifier application number: M020
Tint plus Tone SPF 50. SPF 50 Broad Spectrum Sunscreen Sheer Tinted Moisturizer	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	MDSolarSciences	51bd8962-e85a-4964-9337-2ded6b7d8ac8	2025-06-05	Warnings	Exact identifier application number: M020
Hydrating Sheer Lip Balm SPF 30 -Crystal Broad Spectrum SPF 30 UVA-UVB Sunscreen	AVOBENZONE, OCTISALATE, AND HOMOSALATE	MDSolarSciences	0f23441c-2399-4a72-9f0a-420d25db78af	2025-06-05	Warnings	Exact identifier application number: M020
Vacation Classic Whip SPF 30 Broad Spectrum SPF 30	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Vacation Inc.	36da165b-bc68-24ff-e063-6294a90a304f	2025-06-05	Warnings	Exact identifier application number: M020
Nemah SPF 30 Mineral C/S Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Nemah, Inc.	36da2d94-fa90-b145-e063-6394a90a5854	2025-06-05	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