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 99 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FUTURIST SKIN TINT SERUM	OCTINOXATE,OCTISALATE,ZINC OXIDE	ESTEE LAUDER INC	ea21e5a5-69d6-2de4-e053-2995a90a93b4	2025-12-31	Warnings	Exact identifier application number: M020
Dr.Jart Cicapair Tiger Grass Color Correcting Treatment	ZINC OXIDE, TITANIUM DIOXIDE	Have & Be Co., Ltd.	40f96baf-0359-4d68-801f-68562c909446	2025-12-31	Warnings	Exact identifier application number: M020
Dr.Jart Premium Beauty Balm Fair-Light	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	b38b1b64-b433-4e11-9cf6-2108a552d139	2025-12-31	Warnings	Exact identifier application number: M020
Dr.Jart Premium Beauty Balm Light Medium-Medium	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	45b1c2c6-a45b-4a45-bec9-e5341079c0a1	2025-12-31	Warnings	Exact identifier application number: M020
Dr.Jart Premium Beauty Balm Medium-Tan	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	28a2ba45-1eff-488c-aae4-362b9f78b8df	2025-12-31	Warnings	Exact identifier application number: M020
Dr.Jart Premium Beauty Balm Deep Tan-Deep	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	3c346960-b76b-4241-a188-8ee694853078	2025-12-31	Warnings	Exact identifier application number: M020
DR.JART CICAPAIR TIGER GRASS CAMO DROPS	ZINC OXIDE, TITANIUM DIOXIDE	Have & Be Co., Ltd.	f06348f5-4ebc-325b-e053-2a95a90ada52	2025-12-31	Warnings	Exact identifier application number: M020
DR.JART EVERY SUN DAY MINERAL SUN SCREEN	TITANIUM DIOXIDE, ZINC OXIDE	Have & Be Co., Ltd.	f06c31b4-da5f-6495-e053-2995a90ae67c	2025-12-31	Warnings	Exact identifier application number: M020
ALMOST powder MAKEUP BROAD SPECTRUM SPF 18	OCTINOXATE AND TITANIUM DIOXIDE	CLINIQUE LABORATORIES LLC	402add6d-a81e-4c9e-aee1-4abeb480894f	2025-12-31	Warnings	Exact identifier application number: M020
RED GECKO BROAD SPECTRUM SPF 30 SUNSCREEN	ZINC OXIDE	Formula 7venz L.L.C.	e8e350e7-9225-4802-89a6-66e45ebc442d	2025-12-31	Warnings	Exact identifier application number: M020
Kinfield Daily Dew Sea Kelp Moisturizer Sunscreen Broad Spectrum SPF 35	KINFIELD DAILY DEW SEA KELP MOISTURIZER SUNSCREEN LOTION BROAD SPECTRUM SPF 35	Kinfield, Inc.	0710db9f-fe91-4b98-a337-5fde33d98a9d	2025-12-30	Warnings	Exact identifier application number: M020
Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35	KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35	Kinfield, Inc.	1030c5a4-3067-48e6-a21c-0d327ef434d0	2025-12-30	Warnings	Exact identifier application number: M020
Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35	KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35	Kinfield, Inc.	612c5730-c3b4-486e-8ce9-8a861f676fa8	2025-12-30	Warnings	Exact identifier application number: M020
Kinfield Liplock SPF 15 Lip Balm Broad Spectrum Sunscreen	KINFIELD LIPLOCK SUNSCREEN	Kinfield, Inc.	477aa1a2-c893-4750-84da-e5afe7ccd45b	2025-12-30	Warnings	Exact identifier application number: M020
Kinfield Sunglow Luminizing Facial Sunscreen Broad Spectrum SPF 35	KINFIELD SUNGLOW LUMINIZING FACIAL SUNSCREEN BROAD SPECTRUM SPF 35	Kinfield, Inc.	cbdfd0ae-514b-4b53-98ad-4270163bd0df	2025-12-30	Warnings	Exact identifier application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Fair	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	472f4f34-99bc-2ff6-e063-6294a90a33c9	2025-12-30	Warnings	Exact identifier application number: M020
EVEN BETTER CLINICAL VITAMIN MAKEUP BROAD SPECTRUM SPF 45	ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	2397aca5-bf0a-619d-e063-6394a90a7ab9	2025-12-30	Warnings	Exact identifier application number: M020
Resource Essentials Sun Protection Mineral SPF 30	14% ZINC OXIDE	Skinresource.md, L.L.C.	45b486cf-28ee-6392-e063-6394a90affb0	2025-12-30	Warnings	Exact identifier application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Light Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47313277-8884-70b5-e063-6394a90a5fca	2025-12-30	Warnings	Exact identifier application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47320858-0aea-6ee9-e063-6294a90a9fa9	2025-12-30	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