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 222 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Halo Glow Skin Tint SPF 50 84507	ZINC OXIDE	e.l.f. Cosmetics, Inc.	31314118-0fd6-5549-e063-6394a90a9d1f	2025-03-25	Warnings	Exact identifier application number: M020
Halo Glow Skin Tint SPF 50 84506	ZINC OXIDE	e.l.f. Cosmetics, Inc.	313119be-c1f2-4cb0-e063-6294a90a03ca	2025-03-25	Warnings	Exact identifier application number: M020
Halo Glow Skin Tint SPF50 -84516	ZINC OXIDE	e.l.f. Cosmetics, Inc.	312dd439-5cc8-e034-e063-6394a90a5c76	2025-03-25	Warnings	Exact identifier application number: M020
Halo Glow Skin Tint SPF 50 84504	ZINC OXIDE	e.l.f. Cosmetics, Inc.	223efabb-d018-c337-e063-6394a90a5605	2025-03-25	Warnings	Exact identifier application number: M020
IT Cosmetics Your Skin But Better CC Plus Color Correcting Full Coverage Antiaging Hydrating Serum Broad Spectrum SPF 50 Plus Clear Sunscreen	HOMOSALATE, OCTISALATE AND OCTOCRYLENE	IT COSMETICS, LLC	9f8786cc-bef6-4449-8f31-dfc08de77734	2025-03-25	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Oil Free Matte Poreless Finish Full Coverage Broad Spectrum SPF 40 Sunscreen All Shades	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	b7d184fb-4a9a-4720-9b00-bf0caa257a8c	2025-03-25	Warnings	Exact identifier application number: M020
KISS New York Tinted Moisturizer	ZINC OXIDE	IVY ENTERPRISES, INC.	30cce5b1-ed41-5bf2-e063-6394a90aaf1d	2025-03-24	Warnings	Exact identifier application number: M020
KISS New York Tinted Moisturizer	ZINC OXIDE	IVY ENTERPRISES, INC.	30df95da-4868-1414-e063-6294a90acdac	2025-03-24	Warnings	Exact identifier application number: M020
KISS New York Tinted Moisturizer	ZINC OXIDE	IVY ENTERPRISES, INC.	30e1bd3c-6a0b-a8f8-e063-6394a90acfb7	2025-03-24	Warnings	Exact identifier application number: M020
KISS New York Tinted Moisturizer	ZINC OXIDE	IVY ENTERPRISES, INC.	30e1b4c9-0d77-b08a-e063-6394a90af683	2025-03-24	Warnings	Exact identifier application number: M020
KISS New York Tinted Moisturizer	ZINC OXIDE	IVY ENTERPRISES, INC.	30e1ff3f-0fd0-2880-e063-6294a90a462f	2025-03-24	Warnings	Exact identifier application number: M020
KISS New York Tinted Moisturizer	ZINC OXIDE	IVY ENTERPRISES, INC.	30e25241-0d2b-8c04-e063-6294a90a44b9	2025-03-24	Warnings	Exact identifier application number: M020
Walgreens SPF 50 Clear Complexion Face Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	311ae6d6-d466-3f1d-e063-6294a90ab3dd	2025-03-24	Warnings	Exact identifier application number: M020
DOMINAS DARK SPOT TINTED SUNSCREEN	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H CO., LTD.	2b6140cf-7e34-1658-e063-6394a90a3271	2025-03-24	Warnings	Exact identifier application number: M020
CVS Health SPF 70 Ultra Sheer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	311de9db-941c-5af9-e063-6294a90a3a13	2025-03-24	Warnings	Exact identifier application number: M020
CVS Health SPF 70 Beach Guard Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	311e6378-5afa-d7eb-e063-6394a90a7728	2025-03-24	Warnings	Exact identifier application number: M020
Naked Sundays Golden Glow Body Sunscreen SPF50 100ml	NAKED SUNDAYS GOLDEN GLOW BODY SUNSCREEN SPF50 100ML	NAKED SUNDAYS PTY LTD	e182a39b-89b1-7756-e053-2a95a90ab619	2025-03-23	Warnings	Exact identifier application number: M020
ANTIOXIDANT BODY SUNSCREEN CREME SPF50 BROAD SPECTRUM	AVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,	NAKED SUNDAY PTY LTD	eb7a84a8-3e25-9988-e053-2a95a90a58a9	2025-03-23	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50	TITANIUM OXIDE, ZINC OXIDE	NAKED SUNDAYS PTY LTD	01273e8c-aef0-d800-e063-6294a90abd49	2025-03-23	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50	TITANIUM OXIDE, ZINC OXIDE	NAKED SUNDAYS PTY LTD	01221d57-9eec-7e77-e063-6394a90a6042	2025-03-23	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