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 36 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
White Mint SPF 15 Broad Spectrum Lip Balm	WHITE MINT SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	50ff8c38-94f1-f589-e063-6294a90a5ba8	2026-05-04	Warnings	Exact identifier application number: M020
Surface Sun SPF 50 Mineral	ZINC OXIDE	Surface Products Corp	cabaf7e1-b940-4d6e-b21b-d99c3a4047a7	2026-05-04	Warnings	Exact identifier application number: M020
SPF 50 Dry Touch Continuous No fragrance	HOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%	Surface Products Corp	503d6b48-3516-4264-9fe8-71a9939669fe	2026-05-04	Warnings	Exact identifier application number: M020
Surface SPF 50 3oz Tinted mineral sunscreen with Water Resistance	ZINC OXIDE	Surface Products Corp	02b770cf-7351-444b-b2c8-ad112e9bea3e	2026-05-04	Warnings	Exact identifier application number: M020
SPF 30 Dry Touch Continuous No fragrance	HOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%	Surface Products Corp	d13c9e6e-a5da-4691-8792-9d6025e166d7	2026-05-04	Warnings	Exact identifier application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUM	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	0206c676-c24d-470e-adb2-7cb3173f3727	2026-05-04	Warnings	Exact identifier application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - TAN	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	5c5aad09-9f93-4634-8db1-c67570b38b2b	2026-05-04	Warnings	Exact identifier application number: M020
OBGE PORE-ZERO Oil CONTROL SUN Stick	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Adapt Inc.	67209e46-1b7a-42df-b31f-fcb3cefbd7e1	2026-05-03	Warnings	Exact identifier application number: M020
Equate	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	WALMART INC	2617e5bc-27a2-f187-e063-6394a90a6980	2026-05-03	Warnings	Exact identifier application number: M020
THANK YOU FARMER Sun Project Rice Tinted Mineral Sun Cream	ZINC OXIDE	THANK YOU FARMER CO., LTD	20a44597-3d44-f0ea-e063-6294a90a903d	2026-05-03	Warnings	Exact identifier application number: M020
Ultra Violette Sheen Screen Hydrating Lip Balm Last Bite Broad Spectrum SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Grace and Fire USA Inc.	4df3e90e-98a0-edbf-e063-6394a90ae3c9	2026-05-01	Warnings	Exact identifier application number: M020
Ultra Violette Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum SPF 50	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	Grace and Fire USA Inc.	4df6d28b-64ce-59b3-e063-6394a90a6360	2026-05-01	Warnings	Exact identifier application number: M020
EXTREME PROTECT SPF 30	OCTINOXATE, ZINC OXIDE	SCIENCE OF SKINCARE LLC	ecc4d304-e7e2-45b6-b9b2-2c64d3630860	2026-05-01	Warnings	Exact identifier application number: M020
Blue Lizard Sport SPF 50 Sunscreen	OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	4955fa1c-789d-4f42-af75-70223310644a	2026-05-01	Warnings	Exact identifier application number: M020
Blue Lizard Kids SPF 50 Sunscreen	OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	ba4ae906-48c0-8384-e053-2995a90afb91	2026-05-01	Warnings	Exact identifier application number: M020
Sun Shield Mineral UV Barrier Protect Broad Spectrum SPF 40 Sunscreen	ZINC OXIDE	Obagi Cosmeceuticals LLC	54a3f855-48de-4ae0-b1f0-e95739853065	2026-05-01	Warnings	Exact identifier application number: M020
MEDICUBE PDRN HYDRATING UV SERUM	HOMOSALATE, OCTOCRYLENE, OCTISALATE, ENSULIZOLE	APR US INC	50a73981-985a-0a70-e063-6394a90a89cf	2026-04-30	Warnings	Exact identifier application number: M020
Sky and Sol Body Sunscreen	NON- NANO ZINC OXIDE	Delta Ecommerce LLC	2ddaa628-0e81-c8a7-e063-6394a90a84f4	2026-04-30	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool Rosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	6831832a-e52e-43ea-899f-f5d44bea5a94	2026-04-30	Warnings	Exact identifier application number: M020
Carmex 10 count variety pack Lip Balm	OCTINOXATE, OXYBENZONE, CAMPHOR (SYNTHETIC), WHITE PETROLATUM	Carma Laboratories, Inc.	9c5168d5-31ed-4ce1-b16a-5f51f7e44ed2	2026-04-30	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