SPA SKILHA

Product NDC: 66854-025
11-digit product format: 668540025
Labeler code: 66854
Product ID: 66854-025_469199f3-6194-4eda-8351-c99130f06299
Type: HUMAN OTC DRUG
Nonproprietary name: BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-06-30
Marketing end: 0000-00-00
Substance: BEMOTRIZINOL; OCTINOXATE; AVOBENZONE; TITANIUM DIOXIDE
Active strength: 2 g/100g; g/100g; g/100g; 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66854-025		I	Inactivated by FDA	2026-10-12
excluded package	package	66854-025	66854-025-01	I	Inactivated by FDA	2026-10-12
excluded package	package	66854-025	66854-025-02	I	Inactivated by FDA	2026-10-12
excluded package	package	66854-025	66854-025-03	I	Inactivated by FDA	2026-10-12
excluded package	package	66854-025	66854-025-05	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 2 · 110 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	66854-025-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66854-025-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66854-025-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66854-025-02	`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	66854-025-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66854-025-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66854-025-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66854-025-02	`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	66854-025-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66854-025-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66854-025-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66854-025-02	`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	66854-025-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66854-025-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66854-025-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66854-025-02	`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	66854-025-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66854-025-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66854-025-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66854-025-02	`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	66854-025-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66854-025-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66854-025-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66854-025-02	`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	66854-025-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66854-025-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66854-025-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66854-025-02	`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	66854-025-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66854-025-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66854-025-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66854-025-02	`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	66854-025-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66854-025-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66854-025-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66854-025-02	`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	66854-025-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66854-025-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66854-025-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66854-025-02	`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	66854-025-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66854-025-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66854-025-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66854-025-02	`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	66854-025-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66854-025-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66854-025-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66854-025-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
66854-025-01	SPA SKILHA HELIOPROT AB SPF 40
66854-025-02	SPA SKILHA HELIOPROT AB SPF 40
66854-025-03	SPA SKILHA HELIOPROT AB SPF 40
66854-025-05	SPA SKILHA HELIOPROT AB SPF 40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66854-025-01	SPA SKILHA HELIOPROT AB SPF 40	9 g in 1 JAR	CREAM	9	1
66854-025-02	SPA SKILHA HELIOPROT AB SPF 40	33 g in 1 JAR	CREAM	33	1
66854-025-03	SPA SKILHA HELIOPROT AB SPF 40	60 g in 1 TUBE	CREAM	60	1
66854-025-04	SPA SKILHA HELIOPROT AB SPF 40	15 g in 1 TUBE	CREAM	15	1
66854-025-05	SPA SKILHA HELIOPROT AB SPF 40	20 in 1 BOX	CREAM	20	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
BEMOTRIZINOL	ACTIVE INGREDIENT	PWZ1720CBH	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
BEMOTRIZINOL	ACTIVE MOIETY	PWZ1720CBH	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
CETEARETH-12	INACTIVE INGREDIENT	7V4MR24V5P	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
DIMETHICONOL (41 MPA.S)	INACTIVE INGREDIENT	343C7U75XW	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW)	INACTIVE INGREDIENT	5WE8P977RQ	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
SODIUM CETOSTEARYL SULFATE	INACTIVE INGREDIENT	7ZBS06BH4B	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
WHEAT GERM OIL	INACTIVE INGREDIENT	14C97E680P	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66854-025	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1	Legacy NDC, 5 package rows	20120630_ff3ef5f7-4846-48c6-aebc-26723f7f2320.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PWZ1720CBH	BEMOTRIZINOL	187393-00-6	BEMOTRIZINOL
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
66854-025-01	66854002501	9 g in 1 JAR	9 g	Historical
66854-025-02	66854002502	33 g in 1 JAR	33 g	Historical
66854-025-03	66854002503	60 g in 1 TUBE	60 g	Historical
66854-025-04	66854002504	15 g in 1 TUBE	15 g	Historical
66854-025-05	66854002505	20 in 1 BOX		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SPA SKILHA HELIOPROT AB SPF 40	SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS	2012-06-07	HUMAN OTC DRUG LABEL	1