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 341 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Fair 04	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	e486915b-8097-451a-a018-3279213239b3	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Deepest Deep 30	ZINC OXIDE	Orveon Global US LLC	4054b48e-d8be-4542-9b43-4437c250579b	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Deep 28	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	5b51df09-40c3-4064-96d3-b7366fc83826	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Medium 05	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	f1714e23-030c-4bd9-b9e7-111c3813ed34	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Dark 23	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	828fe263-f223-45c3-9710-fd8d59ad56b1	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Multi-Tasking SPF 20 Concealer Bisque	TITANIUM DIOXIDE	Orveon Global US LLC	d4c30bea-8c56-4ed8-8ec4-f1b1e0e456dd	2023-10-04	Warnings	Exact identifier application number: M020
BareMinerals Mineral Veil	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	64b163dd-8a86-483f-8dab-80fa8740b12f	2023-10-04	Warnings	Exact identifier application number: M020
Laura Mercier Pure Canvas Primer Protecting Broad Spectrum SPF 30 Sunscreen	OCTINOXATE, OCTOCRYLENE, AVOBENZONE, AND OXYBENZONE	Laura Mercier US Buyer LLC	e7903f3d-9c59-f397-e053-2995a90a7895	2023-10-04	Warnings	Exact identifier application number: M020
Laura Mercier Tinted Moisturizer Light Revealer Natural Skin Illuminator Broad Spectrum SPF 25 Sunscreen 0N1 Petal	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Laura Mercier US Buyer LLC	e78e17bf-5606-1031-e053-2a95a90adb35	2023-10-04	Warnings	Exact identifier application number: M020
Laura Mercier Tinted Moisturizer Natural Skin Perfector Broad Spectrum SPF 30 Sunscreen 0N1 Petal	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	Laura Mercier US Buyer LLC	e78f9689-2f8b-1524-e053-2995a90adc79	2023-10-04	Warnings	Exact identifier application number: M020
Laura Mercier Flawless Skin Repair Day Creme Broad Spectrum SPF 15 Sunscreen	AVOBENZONE, OCTINOXATE, AND OXYBENZONE	Laura Mercier US Buyer LLC	e931d389-6b3d-5a7d-e053-2a95a90a7aa3	2023-10-04	Warnings	Exact identifier application number: M020
BANANA BOAT	ZINC OXIDE	Edgewell Personal Care Brands LLC	05bbe530-df26-e598-e063-6394a90a0c59	2023-10-03	Warnings	Exact identifier application number: M020
Native Facial Care Brightening Facial Moisturizer Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	ded27678-0df8-deda-e053-2a95a90a0658	2023-09-28	Warnings	Exact identifier application number: M020
CLEAR IMPROVEMENT PORE CLEARING MOISTURIZER	SALICYLIC ACID	ORIGINS NATURAL RESOURCES INC.	6f9d87fb-2026-4226-b182-ff2a3c40460d	2023-09-12	Warnings	Exact identifier application number: M020
DR ANDREW WEILS FOR ORIGINS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45	TITANIUM DIOXIDE AND ZINC OXIDE	ORIGINS NATURAL RESOURCES INC.	11248cab-c3a5-4e16-8280-9f70bb863cf7	2023-09-11	Warnings	Exact identifier application number: M020
PLANTSCRIPTION SPF 25 POWER ANTI AGING BROAD SPECTRUM 25	AVOBENZONE, HOMOSALATE, OCTISLATE, AND OCTOCRYLENE	ORIGINS NATURAL RESOURCES INC.	c706fed8-f215-4c53-bfc5-2bd87b8f884e	2023-09-11	Warnings	Exact identifier application number: M020
AnubisMed	SPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSION	ANUBIS COSMETICS SL	e99d92c4-8768-9c0a-e053-2a95a90a609e	2023-09-05	Warnings	Exact identifier application number: M020
Anubis Barcelona Protective Line	ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE	ANUBIS COSMETICS SL	ec83846f-11c0-8f59-e053-2995a90ab9d2	2023-09-01	Warnings	Exact identifier application number: M020
eos Natural SPF 15 Lip Balm Pineapple Coconut	ZINC OXIDE	eos Products LLC	039ca738-c2c1-41c8-e063-6394a90ab4c4	2023-08-23	Warnings	Exact identifier application number: M020
Safeguard SPF 40	ZINC OXIDE	Skinsalvation Skincare, Inc.	4730721b-6148-4a80-a749-13c4febf2e38	2023-07-14	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