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 166 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 450 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	8acb660f-94bd-4c4f-b0c1-3682cf8ed543	2025-11-07	Warnings	Exact identifier application number: M020
e.l.f Camo Semi-Matte CC SPF 30 Fair 150 C	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	fad2bec7-c5f4-45f4-aff4-a5022033cb6a	2025-11-07	Warnings	Exact identifier application number: M020
e.l.f Camo Semi-Matte CC SPF 30 Medium 355 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	39856c69-84fb-4b12-a713-8912263e42b1	2025-11-07	Warnings	Exact identifier application number: M020
Bondi Sands Broad Spectrum SPF 60 Sunny Cream Face	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Baxter Laboratories Pty. Ltd.	287aa255-4601-c5be-e063-6394a90a4d74	2025-11-07	Warnings	Exact identifier application number: M020
e l f Holy Hydration Face SPF 30 Sunscreen,	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	44a8028b-731d-4561-b2e3-ee9738ad8d30	2025-11-07	Warnings	Exact identifier application number: M020
e l f Sun Boss Gloss SPF 25 Sunscreen Its your Mauve	ZINC OXIDE	e.l.f. Cosmetics, Inc.	bce21361-c92c-40ad-a373-db3b83b15b8a	2025-11-07	Warnings	Exact identifier application number: M020
e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Bronze Shimmer Sunburst	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	49d912c7-259a-487d-a523-b14031bfaab6	2025-11-07	Warnings	Exact identifier application number: M020
e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Champagne Shimmer Sunlight	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	1e9bdd41-69c3-4034-bd9e-b4bc5a1bd50d	2025-11-07	Warnings	Exact identifier application number: M020
e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Peach Shimmer Sunbeam	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	f818f524-0263-4f89-b4f3-4dd83d688e7e	2025-11-07	Warnings	Exact identifier application number: M020
e.l.f Invisible Sunscreen SPF 35	AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE	e.l.f. Cosmetics, Inc	c2af5591-04df-4958-901e-dbe11698b844	2025-11-07	Warnings	Exact identifier application number: M020
e.l.f Sun Boss Gloss SPF 25 Sunscreen Blush Much	ZINC OXIDE	e.l.f. Cosmetics, Inc.	53d64042-f9ef-494d-a347-490c6a3c49b8	2025-11-07	Warnings	Exact identifier application number: M020
e.l.f. Suntouchable Invisi SPF 50	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	e.l.f cosmetics,Inc.	547eac8c-492e-4a6b-ac58-4f0d1e0ccb3d	2025-11-07	Warnings	Exact identifier application number: M020
e.l.f Sun Boss Gloss SPF 25 Sunscreen Thats my Jam	ZINC OXIDE	e.l.f. Cosmetics, Inc.	b7d56015-4734-4ce4-b40d-64236df810e3	2025-11-07	Warnings	Exact identifier application number: M020
elf Sun Boss Gloss SPF 25 Sunscreen Peachy Kween	ZINC OXIDE	e.l.f. Cosmetics, Inc.	4d9784b6-c54d-483d-a5ba-c557a05300ec	2025-11-07	Warnings	Exact identifier application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 ON THE GLOW	ZINC OXIDE	In The Pynk LLC	13badac4-e310-9589-e063-6394a90ab06b	2025-11-07	Warnings	Exact identifier application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 GOLDEN HOUR	ZINC OXIDE	In The Pynk LLC	13bb8426-27cd-fbc9-e063-6294a90a8bf8	2025-11-07	Warnings	Exact identifier application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 DEW YOU	ZINC OXIDE	In The Pynk LLC	1365c6d8-64cb-3cb3-e063-6394a90a9d64	2025-11-07	Warnings	Exact identifier application number: M020
Well People Bio Tint SPF 30 Sunscreen 10w	ZINC OXIDE	e.l.f. Cosmetics, Inc	c8a935e6-f7ac-4e3a-e053-2a95a90a877a	2025-11-07	Warnings	Exact identifier application number: M020
Well People Bio Tint SPF 30 Sunscreen 11w	ZINC OXIDE	e.l.f. Cosmetics, Inc	c8a94fb4-8752-587c-e053-2995a90a1e9a	2025-11-07	Warnings	Exact identifier application number: M020
Well People Bio Tint SPF 30 Sunscreen 13w	ZINC OXIDE	e.l.f. Cosmetics, Inc	c8a9bf6c-80cd-5884-e053-2a95a90a4a66	2025-11-07	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