Sun Protection Creme SPF 30 PLUS

Product NDC: 53863-122
11-digit product format: 538630122
Labeler code: 53863
Product ID: 53863-122_d1c1d16d-df75-4200-bb9c-671c457f5b9d
Type: HUMAN OTC DRUG
Nonproprietary name: Octocrylene, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Exelencia Importers Corp
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-12-09
Marketing end: 0000-00-00
Substance: OCTOCRYLENE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE
Active strength: 5 g/100mL; g/100mL; g/100mL; g/100mL; g/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	53863-122		I	Inactivated by FDA		2026-10-05
excluded package	package	53863-122	53863-122-02	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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53863-122-02	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53863-122-02	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53863-122-02	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53863-122-02	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53863-122-02	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53863-122-02	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53863-122-02	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53863-122-02	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53863-122-02	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53863-122-02	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53863-122-02	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53863-122-02	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53863-122-02	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53863-122-02	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53863-122-02	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53863-122-02	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53863-122-02	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53863-122-02	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53863-122-02	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53863-122-02	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53863-122-02	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53863-122-02	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53863-122-02	2020-01-31	C162847	48780-1	9d75b9cf-e264-f424-e053-dadaa90a57ce	Exel Clarifying SPF 30 Plus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53863-122-01	Sun Protection Creme SPF 30 PLUSExel Clarifying Line	97.5 mL in 1 BOTTLE	CREAM	97.5		2
53863-122-02	Sun Protection Creme SPF 30 PLUSExel Clarifying Line	1 in 1 CARTON	CREAM	1		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
HAMAMELIS VIRGINIANA LEAF	INACTIVE INGREDIENT	T07U1161SV	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53863-122	SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE (OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ EXELENCIA IMPORTERS CORP]	2	Legacy NDC, 2 package rows	20141211_c2dc2f0d-033a-49d2-8dee-86cc71854996.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53863-122-01	53863012201	97.5 mL in 1 BOTTLE	97.5 ml	Historical
53863-122-02	53863012202	1 in 1 CARTON		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Exel Clarifying SPF 30 Plus	Exelencia Importers Corp \| BIOCOSMETICA EXEL ARGENTINA S.R.L.	2014-12-11	HUMAN OTC DRUG LABEL	2