DERMAPROT

Product NDC: 66854-026
11-digit product format: 668540026
Labeler code: 66854
Product ID: 66854-026_3aa210bd-65ec-411f-9328-2dc7ae4cd504
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE
Dosage form: LOTION
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: OCTINOXATE; TITANIUM DIOXIDE; AVOBENZONE; OXYBENZONE
Active strength: 8 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66854-026		I	Inactivated by FDA	2026-10-12
excluded package	package	66854-026	66854-026-01	I	Inactivated by FDA	2026-10-12
excluded package	package	66854-026	66854-026-02	I	Inactivated by FDA	2026-10-12
excluded package	package	66854-026	66854-026-03	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 · 88 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	66854-026-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66854-026-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66854-026-01	`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	66854-026-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66854-026-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66854-026-01	`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	66854-026-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66854-026-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66854-026-01	`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	66854-026-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66854-026-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66854-026-01	`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	66854-026-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66854-026-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66854-026-01	`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	66854-026-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66854-026-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66854-026-01	`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	66854-026-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66854-026-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66854-026-01	`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	66854-026-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66854-026-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66854-026-01	`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	66854-026-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66854-026-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66854-026-01	`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	66854-026-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66854-026-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66854-026-01	`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	66854-026-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66854-026-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66854-026-01	`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	66854-026-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66854-026-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66854-026-01	`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	66854-026-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66854-026-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66854-026-01	`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	66854-026-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66854-026-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66854-026-01	`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	66854-026-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66854-026-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66854-026-01	`1332a3947898…`	`d4bfe170f9cd…`

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
66854-026-01	2019-11-13	C162847	48780-1	97449f38-b831-f6ea-e053-dbdaa90aa703	DERMAPROT HELIOPROT LOCION ANTISOLAR SPF 30
66854-026-02	2019-11-13	C162847	48780-1	97449f38-b831-f6ea-e053-dbdaa90aa703	DERMAPROT HELIOPROT LOCION ANTISOLAR SPF 30
66854-026-03	2019-11-13	C162847	48780-1	97449f38-b831-f6ea-e053-dbdaa90aa703	DERMAPROT HELIOPROT LOCION ANTISOLAR SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66854-026-01	DERMAPROTHELIOPROT AB SPF 30	10 mL in 1 BOTTLE	LOTION	10	1
66854-026-02	DERMAPROTHELIOPROT AB SPF 30	45 mL in 1 BOTTLE	LOTION	45	1
66854-026-03	DERMAPROTHELIOPROT AB SPF 30	70 mL in 1 BOTTLE	LOTION	70	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
CHAMOMILE FLOWER OIL	INACTIVE INGREDIENT	60F80Z61A9	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
DICAPRYLYL CARBONATE	INACTIVE INGREDIENT	609A3V1SUA	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
SODIUM CETOSTEARYL SULFATE	INACTIVE INGREDIENT	7ZBS06BH4B	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66854-026	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1	Legacy NDC, 3 package rows	20120809_1121cb01-8d2f-4b80-a86f-0f4b18ff34d6.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
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
66854-026-01	66854002601	10 mL in 1 BOTTLE	10 ml	Historical
66854-026-02	66854002602	45 mL in 1 BOTTLE	45 ml	Historical
66854-026-03	66854002603	70 mL in 1 BOTTLE	70 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DERMAPROT HELIOPROT LOCION ANTISOLAR SPF 30	SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS	2012-06-07	HUMAN OTC DRUG LABEL	1