Sunscreen

Product NDC: 35192-008
11-digit product format: 351920008
Labeler code: 35192
Product ID: 35192-008_504333a6-c975-42e9-b6f8-90fcc2788f71
Type: HUMAN OTC DRUG
Nonproprietary name: SPF 40
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: TITANIUM DIOXIDE; OCTINOXATE
Active strength: 7 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	35192-008		I	Inactivated by FDA		2026-10-05
excluded package	package	35192-008	35192-008-02	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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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	35192-008-02	`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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
e2dae634-14ed-febf-08ee-93196433b5b7	Product name	9	20190614
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
0a5e5249-329b-0cff-e714-77159f193a87	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
35192-008-02	2019-11-13	C162847	48780-1	97449f38-bea0-f6ea-e053-dbdaa90aa703	6236 SPF40 Umbrella Sunscreen Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
35192-008-02	Sunscreen	113.4 g in 1 TUBE	LOTION	113.4		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
ALUMINUM STARCH OCTENYLSUCCINATE	INACTIVE INGREDIENT	I9PJ0O6294	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
BORON NITRIDE	INACTIVE INGREDIENT	2U4T60A6YD	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES	INACTIVE INGREDIENT	U72Q2I8C85	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
CETEARYL ISONONANOATE	INACTIVE INGREDIENT	P5O01U99NI	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
GRAPE SEED OIL	INACTIVE INGREDIENT	930MLC8XGG	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
ISOMALT	INACTIVE INGREDIENT	S870P55O2W	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
MACADAMIA OIL	INACTIVE INGREDIENT	515610SU8C	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
NIACIN	INACTIVE INGREDIENT	2679MF687A	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
PROPANEDIOL	INACTIVE INGREDIENT	5965N8W85T	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
ROSA MOSCHATA OIL	INACTIVE INGREDIENT	J99W255AWF	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
ROSEMARY	INACTIVE INGREDIENT	IJ67X351P9	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
TETRASODIUM IMINODISUCCINATE	INACTIVE INGREDIENT	GYS41J2635	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35192-008	SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]	1	Legacy NDC, 1 package rows	20120601_20217be3-4ddb-4d2f-9b77-0afa4c69eeea.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
35192-008-02	35192000802	113.4 g in 1 TUBE	113.4 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
6236 SPF40 Umbrella Sunscreen Lotion	CA-BOTANA INTERNATIONAL \| RODOLFO UGELSTAD	2012-06-01	HUMAN OTC DRUG LABEL	1