Shimmery Sun

Product NDC: 35192-006
11-digit product format: 351920006
Labeler code: 35192
Product ID: 35192-006_5e651d2d-7b9b-4ef7-864d-a632b06fdd9e
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate Titanium Dioxide
Dosage form: LOTION
Route: TOPICAL
Labeler: CA-BOTANA INTERNATIONAL
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-06-01
Marketing end: 0000-00-00
Substance: OCTINOXATE; TITANIUM DIOXIDE
Active strength: 6 g/113.4g; g/113.4g
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	35192-006		I	Inactivated by FDA		2026-10-12
excluded package	package	35192-006	35192-006-02	I	Inactivated by FDA		2026-10-12

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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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	35192-006-02	`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
e2dae634-14ed-febf-08ee-93196433b5b7	Product name	9	20190614
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
0a5e5249-329b-0cff-e714-77159f193a87	Product name	1	20140508
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8	Product name	1	20140508
d394f843-7479-dc48-dbd3-232266c5548c	Product name	1	20140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
35192-006-02	2019-11-13	C162847	48780-1	97449f38-bf8d-f6ea-e053-dbdaa90aa703	Sunscreen Shimmery Sun

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
35192-006-02	Shimmery Sun	113.4 g in 1 TUBE	LOTION	113.4		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
.ALPHA.-BISABOLOL, (+/-)-	INACTIVE INGREDIENT	36HQN158VC	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
ALANINE	INACTIVE INGREDIENT	OF5P57N2ZX	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
ARGININE	INACTIVE INGREDIENT	94ZLA3W45F	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES	INACTIVE INGREDIENT	U72Q2I8C85	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
CETEARYL ISONONANOATE	INACTIVE INGREDIENT	P5O01U99NI	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
COCONUT	INACTIVE INGREDIENT	3RT3536DHY	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
GRAPE SEED OIL	INACTIVE INGREDIENT	930MLC8XGG	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
MICA	INACTIVE INGREDIENT	V8A1AW0880	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
NIACIN	INACTIVE INGREDIENT	2679MF687A	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
OLEA EUROPAEA LEAF	INACTIVE INGREDIENT	MJ95C3OH47	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
PENTYLENE GLYCOL	INACTIVE INGREDIENT	50C1307PZG	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
PROPANEDIOL	INACTIVE INGREDIENT	5965N8W85T	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
ROSA MOSCHATA OIL	INACTIVE INGREDIENT	J99W255AWF	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
ROSEMARY	INACTIVE INGREDIENT	IJ67X351P9	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
SODIUM PYROPHOSPHATE	INACTIVE INGREDIENT	O352864B8Z	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
SORBITAN	INACTIVE INGREDIENT	6O92ICV9RU	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
UREA	INACTIVE INGREDIENT	8W8T17847W	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35192-006	SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]	7	Legacy NDC, 1 package rows	20120709_345641f0-0148-4e30-843a-6516cf7bad1d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
35192-006-02	35192000602	113.4 g in 1 TUBE	113.4 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sunscreen Shimmery Sun	CA-BOTANA INTERNATIONAL \| RODOLFO UGELSTAD	2012-06-01	HUMAN OTC DRUG LABEL	7