iBlanc Restora-Bright Elite Natural Sun Defense

Product NDC: 52960-201
11-digit product format: 529600201
Labeler code: 52960
Product ID: 52960-201_d21fa970-c7f7-4f19-af10-15beec658272
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: LOTION
Route: TOPICAL
Labeler: iBlanc, Inc.
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-09-23
Marketing end: 0000-00-00
Substance: ZINC OXIDE
Active strength: 14 g/100g
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52960-201		I	Inactivated by FDA		2026-10-05
excluded package	package	52960-201	52960-201-12	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52960-201-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52960-201-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52960-201-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52960-201-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52960-201-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52960-201-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52960-201-12	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52960-201-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52960-201-12	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52960-201-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52960-201-12	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52960-201-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52960-201-12	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52960-201-12	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52960-201-12	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52960-201-12	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52960-201-12	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52960-201-12	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52960-201-12	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52960-201-12	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	52960-201-12	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	52960-201-12	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52960-201-12	2019-11-27	C162847	48780-1	9855d018-e741-cd31-e053-dbdaa90ab51a	1d7f1ddb-108f-49f4-baf4-5a457ff5e08e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52960-201-12	iBlanc Restora-Bright Elite Natural Sun DefenseSPF 30	45 g in 1 TUBE	LOTION	45		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
ALEURITES MOLUCCANA SEED	INACTIVE INGREDIENT	J87WJ3E7VW	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
BARLEY	INACTIVE INGREDIENT	5PWM7YLI7R	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES	INACTIVE INGREDIENT	U72Q2I8C85	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
DOCOSANOL	INACTIVE INGREDIENT	9G1OE216XY	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
ERGOTHIONEINE	INACTIVE INGREDIENT	BDZ3DQM98W	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
ETHYL MACADAMIATE	INACTIVE INGREDIENT	ANA2NCS6V1	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
GLYCERYL ISOSTEARATE	INACTIVE INGREDIENT	HYE7O27HAO	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	INACTIVE INGREDIENT	T7S323PKJS	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
HYDROGENATED PALM GLYCERIDES	INACTIVE INGREDIENT	YCZ8EM144Q	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
HYDROLYZED JOJOBA ESTERS (ACID FORM)	INACTIVE INGREDIENT	UDR641JW8W	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN	INACTIVE INGREDIENT	9F8ET54T05	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
ISODECYL NEOPENTANOATE	INACTIVE INGREDIENT	W60VYE24XC	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
LONICERA CAPRIFOLIUM FLOWER	INACTIVE INGREDIENT	5N1WD9784U	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
LONICERA JAPONICA FLOWER	INACTIVE INGREDIENT	4465L2WS4Y	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
MACADAMIA OIL	INACTIVE INGREDIENT	515610SU8C	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
MALIC ACID, L-	INACTIVE INGREDIENT	J3TZF807X5	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
PHELLODENDRON AMURENSE BARK	INACTIVE INGREDIENT	PBG27B754G	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
PHYTIC ACID	INACTIVE INGREDIENT	7IGF0S7R8I	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
POLYGLYCERYL-10 STEARATE	INACTIVE INGREDIENT	90TF85HH91	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
POLYHYDROXYSTEARIC ACID (2300 MW)	INACTIVE INGREDIENT	YXH47AOU0F	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
PORPHYRA UMBILICALIS	INACTIVE INGREDIENT	14AN0J70WO	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
RICE BRAN OIL	INACTIVE INGREDIENT	LZO6K1506A	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
SANDALWOOD	INACTIVE INGREDIENT	3641YW25N2	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
SODIUM LACTATE	INACTIVE INGREDIENT	TU7HW0W0QT	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
SODIUM STEAROYL LACTYLATE	INACTIVE INGREDIENT	IN99IT31LN	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52960-201	IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]	3	Legacy NDC, 1 package rows	20121027_1d7f1ddb-108f-49f4-baf4-5a457ff5e08e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
52960-201-12	52960020112	45 g in 1 TUBE	45 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
iBlanc Restora-Bright Elite Natural Sun Defense SPF 30 - iBlanc, Inc.	iBlanc, Inc.	2012-10-26	HUMAN OTC DRUG LABEL	3