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 9 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Continuous Correction Cream	HOMOSALATE 10% OCTISALATE 4.9% OCTOCRYLENE 4%	Baxter of California, LLC	14b05c8c-0398-2973-e063-6394a90a8a86	2026-07-31	Warnings	Exact identifier application number: M020
Cover Creme	TITANIUM DIOXIDE	Baxter of California	31f5e8c4-523f-4596-e063-6294a90a6a12	2026-07-31	Warnings	Exact identifier application number: M020
MELAO GHK-Cu PEPTIDE SUNSCREEN	BUTYL METHOXYDIBENZOYLMETHANE,ETHYLHEXYL SALICYLATE,HOMOSALATE,OCTOCRYLENE	Guangdong Aimu Biological Technology Co., Ltd	57a8c34a-d6c9-c03e-e063-6394a90a7af1	2026-07-29	Warnings	Exact identifier application number: M020
BelleJoss BROAD SPECTRUM SPF 50	BROAD SPECTRUM SPF 50	Guangzhou Liyan Cosmetics Technology Co., Ltd.	57c07f29-2e23-d18a-e063-6394a90a1020	2026-07-29	Warnings	Exact identifier application number: M020
BemeJolie BROAD SPECTRUM SPF 50	BROAD SPECTRUM SPF 50	Guangzhou Liyan Cosmetics Technology Co., Ltd.	57c27cea-bb0c-5d2d-e063-6394a90a1b48	2026-07-29	Warnings	Exact identifier application number: M020
DeFlame	ALLANTOIN	Noon Aesthetics M.R. Ltd	2628bd73-0ca9-497b-bcd9-088444cd62be	2026-07-28	Warnings	Exact identifier application number: M020
Native Mineral Suncare Broad Spectrum SPF 30 Unscented	ZINC OXIDE	The Procter & Gamble Manufacturing Company	3a89238b-d1ee-d7fa-e063-6294a90ae55f	2026-07-28	Warnings	Exact identifier application number: M020
First Aid Beauty FAB Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	dfb1b42e-c821-1a41-e053-2995a90acf95	2026-07-28	Warnings	Exact identifier application number: M020
HEB 50 Pumpkin Spice Latte Scent Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B.	579f3274-398e-7eab-e063-6394a90afe35	2026-07-27	Warnings	Exact identifier application number: M020
LUXE COLOR FOUNDATION	OCTINOXATE 7% ZINC OXIDE 5%	Guangzhou Huixue Biotechnology Co., Ltd.	576c3496-702f-808c-e063-6394a90a53c3	2026-07-25	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25 Kit	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Xact Packing Limited	5759058d-e683-f3fc-e063-6394a90abc01	2026-07-24	Warnings	Exact identifier application number: M020
No7 Future Renew Defense Shield SPF 50	AVOBENZONE, OCTINOXATE, OCTISALATE	Xact Packing Limited	5758b79f-6386-bbea-e063-6394a90aeb34	2026-07-24	Warnings	Exact identifier application number: M020
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	BEL STAR S.A.	575fb2c3-e332-8a3b-e063-6394a90a9fd9	2026-07-24	Warnings	Exact identifier application number: M020
SERVE AND PRIME SUNSCREEN BROAD SPECTRUM SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	ESTEE LAUDER INC	575fc04a-794a-93e7-e063-6394a90a7e67	2026-07-24	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT	ZINC OXIDE	Younique, LLC	f93d42a9-b655-4b75-a16d-b29f38f04efc	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT MEDIUM	ZINC OXIDE	Younique, LLC	82769819-b229-4864-9b3c-44f49a68a53a	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR	ZINC OXIDE	Younique, LLC	ed700cae-8226-48d9-93ba-03154aa1cae5	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR LIGHT	ZINC OXIDE	Younique, LLC	d728b89c-692f-485b-88c3-929b2f0350d5	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM	ZINC OXIDE	Younique, LLC	a49dfff1-e9ec-4573-90b0-ef6a7226aa56	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM DARK	ZINC OXIDE	Younique, LLC	cc576b63-caf4-491d-8d7f-027b1127133b	2026-07-23	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