ISA KNOX SMART BB SUN

Product NDC: 53208-520
11-digit product format: 532080520
Labeler code: 53208
Product ID: 53208-520_216c9add-5ee7-494d-b2d2-00bf91e66cc5
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL
Dosage form: CREAM
Route: TOPICAL
Labeler: LG Household and Healthcare, Inc.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-04-12
Marketing end: 0000-00-00
Substance: OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE; HYDROXYPROLINE; ATRACTYLODES JAPONICA ROOT OIL
Active strength: 7 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL
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	53208-520		I	Inactivated by FDA		2026-10-05
excluded package	package	53208-520	53208-520-02	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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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	53208-520-02	`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
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
910c1bd7-67d1-44c7-ad4f-9445f827edcc	Product name	1	20230808
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53208-520-02	2019-10-29	C162847	48780-1	960f7f55-cd9d-8e05-e053-dbdaa90a074a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53208-520-01	ISA KNOX SMART BB SUN	60 mL in 1 CONTAINER	CREAM	60		1
53208-520-02	ISA KNOX SMART BB SUN	1 in 1 BOX	CREAM	1		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATRACTYLODES JAPONICA ROOT OIL	ACTIVE INGREDIENT	EC228KGY00	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
HYDROXYPROLINE	ACTIVE INGREDIENT	RMB44WO89X	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
ATRACTYLODES JAPONICA ROOT OIL	ACTIVE MOIETY	EC228KGY00	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
HYDROXYPROLINE	ACTIVE MOIETY	RMB44WO89X	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
ACETATE ION	INACTIVE INGREDIENT	569DQM74SC	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
CANNA INDICA ROOT	INACTIVE INGREDIENT	BZK836AQFQ	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
DISTEARYLDIMONIUM CHLORIDE	INACTIVE INGREDIENT	OM9573ZX3X	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
ENSULIZOLE	INACTIVE INGREDIENT	9YQ9DI1W42	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
HECTORITE	INACTIVE INGREDIENT	08X4KI73EZ	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
IRON	INACTIVE INGREDIENT	E1UOL152H7	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
MAGNESIUM SULFATE, UNSPECIFIED	INACTIVE INGREDIENT	DE08037SAB	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
MARITIME PINE	INACTIVE INGREDIENT	50JZ5Z98QY	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
METHYL TRIMETHICONE	INACTIVE INGREDIENT	S73ZQI0GXM	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
SACCHARIDE ISOMERATE	INACTIVE INGREDIENT	W8K377W98I	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
TRISILOXANE	INACTIVE INGREDIENT	9G1ZW13R0G	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53208-520	ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]	1	Legacy NDC, 2 package rows	20110415_3b4ab30b-920a-4790-8f3b-8c744f2f6a57.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
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
RMB44WO89X	HYDROXYPROLINE	51-35-4	HYDROXYPROLINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53208-520-01	53208052001	60 mL in 1 CONTAINER	60 ml	Historical
53208-520-02	53208052002	1 in 1 BOX		Historical