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 69 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALOE KOTE SPF 25	OCTINOXATE, OXYBENZONE, HOMOSALATE	Aloe Care International, LLC	12e78c53-ba19-4c8e-bd2f-8c85fccbc179	2026-01-26	Warnings	Exact identifier application number: M020
ALOE UP KIDS SPORT SUNSCREEN SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Aloe Care International, LLC	62016e94-b5d2-4ba2-ab9c-b0b2c1ead650	2026-01-26	Warnings	Exact identifier application number: M020
Homosalate 10 Avobenzone 3% Octocrylene 6%	SPF 45 FACE	S&C Hampton Sun LLC	e49808c9-5025-4965-8679-7fe824cf6907	2026-01-26	Warnings	Exact identifier application number: M020
ENVIRONMENTAL DEFENSE	ZINC OXIDE	Avasol LLC	1fbddab4-71f7-4167-ad21-30040b7c71bb	2026-01-26	Warnings	Exact identifier application number: M020
Surfers Barrier	ZINC OXIDE	Avasol LLC	d6e2ac0a-3bf6-4d08-8647-6a23de2ac857	2026-01-26	Warnings	Exact identifier application number: M020
SURFERS BARRIER SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	Avasol LLC	ec55eef0-17e6-416d-bd5e-548f2f323cea	2026-01-26	Warnings	Exact identifier application number: M020
Zenskin Watery Dew Nia-Cica Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREEN	Zenskin Co. Ltd.	49584899-d523-9677-e063-6394a90a1403	2026-01-26	Warnings	Exact identifier application number: M020
Caring mill sun serum with Vitamin C Niacinamide	HOMOSALATE OCTOCRYLENE OCTISALATE AVOBENZONE	FSA Store lnc.	4931ee71-1088-1ac1-e063-6294a90ad82b	2026-01-25	Warnings	Exact identifier application number: M020
Caring mill Mineral Eye Cream	ZINC OXIDE	FSA STORE INC.	4932ea19-28cc-b245-e063-6394a90ac7aa	2026-01-25	Warnings	Exact identifier application number: M020
Ceile SPF 30 prime PROTECT Broad Spectrum SPF 30 Sunscreen	SUNSCREEN 30 MINERAL	LE COSMETICS INC	2cee0413-d532-c192-e063-6294a90aa823	2026-01-25	Warnings	Exact identifier application number: M020
BeginS by JUNGSAEMMOOL Blue Chamomile Hyaluronic Acid Aqua Sunscreen Broad Spectrum SPF 50 plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Jungsaemmool Beauty Co., Ltd.	62e23503-7233-434a-91f0-092f10d2717d	2026-01-24	Warnings	Exact identifier application number: M020
BeginS by JUNGSAEMMOOL Blue Chamomile Hyaluronic Acid Airy Sun Stick Broad Spectrum SPF 50 plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Jungsaemmool Beauty Co., Ltd.	030a20fb-4846-4a5c-9808-a399aac2ff0b	2026-01-24	Warnings	Exact identifier application number: M020
Mimosa Lane SPF45	OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREEN	R&G Divergency LLC	40f3b8ea-bfa5-4c66-9c79-c4408bda857a	2026-01-24	Warnings	Exact identifier application number: M020
111 SKIN SUNSCREEN SPF 50	ZINC OXIDE	Bentley Laboratories, LLC	b1265797-71dd-4302-ab26-dbff6ccec856	2026-01-23	Warnings	Exact identifier application number: M020
Mania Holic Sunscreen Pack	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	Firstmarket Co., ltd.	b95a460c-1f7b-4193-b305-466e073af640	2026-01-23	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 320	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	1cdbae71-441b-426d-99ee-c889d76af452	2026-01-23	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 250	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	8f4b5e0a-4578-4af3-b7d9-a19d4eb732e7	2026-01-23	Warnings	Exact identifier application number: M020
ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PA	TITANIUM DIOXIDE	LG Household and Healthcare, Inc.	65e70306-9e79-494d-9217-a43002f16307	2026-01-23	Warnings	Exact identifier application number: M020
O HUI Sun Science Ideal Cover Sunscreen Broad Spectrum	TITANIUM DIOXIDE	LG Household and Healthcare, Inc.	c15ffd23-271d-458d-9048-9bc50331d5d7	2026-01-23	Warnings	Exact identifier application number: M020
Aqua protection Sunscreen Broad Spectrum SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ENGLEWOOD LAB, INC.	627e6ea5-016b-4ab6-a50c-aa9c27e5cca1	2026-01-23	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