Sunsect Insect Repellent Sunscreen

Product NDC: 57595-001
11-digit product format: 575950001
Labeler code: 57595
Product ID: 57595-001_bfad4f43-3418-4a2a-9acf-483a688abbb0
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate, oxybenzone, octisalate
Dosage form: LOTION
Route: TOPICAL
Labeler: Iguana LLC
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2015-06-01
Marketing end: 0000-00-00
Substance: OCTISALATE; OCTINOXATE; OXYBENZONE; DIETHYLTOLUAMIDE
Active strength: 5 g/100g; g/100g; g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2020-12-31
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	57595-001		I	Inactivated by FDA	2026-08-17
excluded package	package	57595-001	57595-001-01	I	Inactivated by FDA	2026-08-17
excluded package	package	57595-001	57595-001-02	I	Inactivated by FDA	2026-08-17
excluded package	package	57595-001	57595-001-03	I	Inactivated by FDA	2026-08-17
excluded package	package	57595-001	57595-001-04	I	Inactivated by FDA	2026-08-17

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 · 100 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	57595-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57595-001-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57595-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57595-001-04	`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	57595-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57595-001-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57595-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57595-001-04	`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	57595-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57595-001-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57595-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57595-001-04	`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	57595-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57595-001-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57595-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57595-001-04	`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	57595-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57595-001-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57595-001-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57595-001-04	`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	57595-001-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57595-001-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57595-001-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57595-001-04	`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	57595-001-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57595-001-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57595-001-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57595-001-04	`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	57595-001-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57595-001-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57595-001-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57595-001-04	`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	57595-001-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57595-001-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57595-001-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57595-001-04	`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	57595-001-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57595-001-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57595-001-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57595-001-04	`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	57595-001-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57595-001-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57595-001-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57595-001-04	`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	57595-001-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57595-001-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57595-001-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57595-001-04	`557ba5c1ecfa…`	`9c80585c8c6e…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
57595-001-01	2020-09-27	Drug Facts
57595-001-02	2020-09-27	Drug Facts
57595-001-03	2020-09-27	Drug Facts
57595-001-04	2020-09-27	Drug Facts
57595-001-01	2020-09-25	Drug Facts
57595-001-02	2020-09-25	Drug Facts
57595-001-03	2020-09-25	Drug Facts
57595-001-04	2020-09-25	Drug Facts
57595-001-01	2020-07-22	Drug Facts
57595-001-02	2020-07-22	Drug Facts
57595-001-03	2020-07-22	Drug Facts
57595-001-04	2020-07-22	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57595-001-01	Sunsect Insect Repellent Sunscreen	59 g in 1 BOTTLE, PLASTIC	LOTION	59	2
57595-001-02	Sunsect Insect Repellent Sunscreen	118 g in 1 BOTTLE, PLASTIC	LOTION	118	2
57595-001-03	Sunsect Insect Repellent Sunscreen	3672 g in 1 BOTTLE, PUMP	LOTION	3672	2
57595-001-04	Sunsect Insect Repellent Sunscreen	9 g in 1 PACKET	LOTION	9	2
57595-001-04	Sunsect Insect Repellent Sunscreen	50 in 1 BOX	LOTION	50	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIETHYLTOLUAMIDE	ACTIVE INGREDIENT	FB0C1XZV4Y	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
DIETHYLTOLUAMIDE	ACTIVE MOIETY	FB0C1XZV4Y	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	809Y72KV36	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
Carrageenan	INACTIVE INGREDIENT	5C69YCD2YJ	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
CITRONELLA OIL	INACTIVE INGREDIENT	QYO8Q067D0	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
DIETHANOLAMINE CETYL PHOSPHATE	INACTIVE INGREDIENT	4UG0316V9S	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
TRICONTANYL POVIDONE	INACTIVE INGREDIENT	N0SS3Q238D	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57595-001	SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]	2	Legacy NDC, 5 package rows	20150701_6ccdc093-8af9-4bd8-84b0-f229fccd2f1c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
FB0C1XZV4Y	DIETHYLTOLUAMIDE	134-62-3	DIETHYLTOLUAMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
57595-001-01	57595000101	59 g in 1 BOTTLE, PLASTIC	59 g	Historical
57595-001-02	57595000102	118 g in 1 BOTTLE, PLASTIC	118 g	Historical
57595-001-03	57595000103	3672 g in 1 BOTTLE, PUMP	3672 g	Historical
57595-001-04	57595000104	9 g in 1 PACKET	9 g	Historical