SkinCeuticals Physical Eye UV Defense Sunscreen

Product NDC: 49967-050
Requested package NDC: 49967-050-02
11-digit product format: 499670050
Labeler code: 49967
Product ID: 49967-050_1eff0fec-e084-440c-9b1b-96bcc8672fc7
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium dioxide and Zinc oxide
Dosage form: LOTION
Route: TOPICAL
Labeler: L'Oreal USA Products Inc
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-04-18
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 90 mg/mL; mg/mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	49967-050	49967-050-02	D	Discontinued by firm		2026-10-05

Adverse event summaries are temporarily unavailable. Other product information remains available.

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49967-050-01	SkinCeuticals Physical Eye UV Defense Sunscreen	10 mL in 1 TUBE	LOTION	10	9
49967-050-01	SkinCeuticals Physical Eye UV Defense Sunscreen	1 in 1 CARTON	LOTION	1	9
49967-050-02	SkinCeuticals Physical Eye UV Defense Sunscreen	0.15 mL in 1 PACKET	LOTION	0.15	9

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	SKINCEUTICALS PHYSICAL EYE UV DEFENSE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]	2
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	SKINCEUTICALS PHYSICAL EYE UV DEFENSE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]	2
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	SKINCEUTICALS PHYSICAL EYE UV DEFENSE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]	2
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	SKINCEUTICALS PHYSICAL EYE UV DEFENSE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49967-050	SKINCEUTICALS PHYSICAL EYE UV DEFENSE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]	9	Legacy NDC, 3 package rows	20241230_5fb2ec75-6d79-4b06-839c-2e0976309942.zip

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

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49967-050-02	49967005002	.15 mL in 1 PACKET (49967-050-02)	2014-04-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	L'Oreal USA Products Inc \| Goodier Cosmetics LP \| Beauty Manufacturing Solutions Corp.	2024-12-28	HUMAN OTC DRUG LABEL	9