SS-TMPFL

Product NDC: 58418-001
11-digit product format: 584180001
Labeler code: 58418
Product ID: 58418-001_a05e42d9-4842-6b2a-e053-2995a90a7b12
Type: HUMAN OTC DRUG
Nonproprietary name: BS Spf30 spray - DL
Dosage form: SPRAY
Route: TOPICAL
Labeler: Tropical Enterprises International, Inc.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2018-10-01
Marketing end: 0000-00-00
Substance: OCTOCRYLENE; AVOBENZONE
Active strength: 2 g/30mL; g/30mL
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 13 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	58418-001		I	Inactivated by FDA	2026-10-05
excluded package	package	58418-001	58418-001-01	I	Inactivated by FDA	2026-10-05
excluded package	package	58418-001	58418-001-02	I	Inactivated by FDA	2026-10-05
excluded package	package	58418-001	58418-001-04	I	Inactivated by FDA	2026-10-05
excluded package	package	58418-001	58418-001-08	I	Inactivated by FDA	2026-10-05
excluded package	package	58418-001	58418-001-10	I	Inactivated by FDA	2026-10-05
excluded package	package	58418-001	58418-001-12	I	Inactivated by FDA	2026-10-05
excluded package	package	58418-001	58418-001-16	I	Inactivated by FDA	2026-10-05
excluded package	package	58418-001	58418-001-25	I	Inactivated by FDA	2026-10-05
excluded package	package	58418-001	58418-001-28	I	Inactivated by FDA	2026-10-05
excluded package	package	58418-001	58418-001-32	I	Inactivated by FDA	2026-10-05
excluded package	package	58418-001	58418-001-64	I	Inactivated by FDA	2026-10-05
excluded package	package	58418-001	58418-001-70	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 4 · 234 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	58418-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58418-001-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58418-001-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58418-001-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58418-001-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58418-001-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58418-001-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58418-001-64	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58418-001-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58418-001-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58418-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58418-001-28	`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	58418-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58418-001-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58418-001-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58418-001-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58418-001-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58418-001-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58418-001-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58418-001-64	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58418-001-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58418-001-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58418-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58418-001-28	`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	58418-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58418-001-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58418-001-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58418-001-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58418-001-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58418-001-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58418-001-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58418-001-64	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58418-001-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58418-001-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58418-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58418-001-28	`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	58418-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58418-001-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58418-001-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58418-001-70	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58418-001-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58418-001-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58418-001-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58418-001-64	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58418-001-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58418-001-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58418-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58418-001-28	`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	58418-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58418-001-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58418-001-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58418-001-70	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58418-001-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58418-001-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58418-001-12	`cfe11265f3b6…`	`090c488252e2…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
58418-001-01	2022-01-28	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-02	2022-01-28	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-04	2022-01-28	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-08	2022-01-28	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-10	2022-01-28	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-12	2022-01-28	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-16	2022-01-28	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-25	2022-01-28	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-28	2022-01-28	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-32	2022-01-28	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-64	2022-01-28	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-70	2022-01-28	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-01	2020-02-03	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-02	2020-02-03	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-04	2020-02-03	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-08	2020-02-03	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-10	2020-02-03	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-12	2020-02-03	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-16	2020-02-03	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-28	2020-02-03	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-64	2020-02-03	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-01	2020-01-31	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-02	2020-01-31	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-04	2020-01-31	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-08	2020-01-31	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-10	2020-01-31	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-12	2020-01-31	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-16	2020-01-31	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-28	2020-01-31	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-64	2020-01-31	SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58418-001-01	SS-TMPFL	30 mL in 1 BOTTLE, DISPENSING	SPRAY	30	3
58418-001-02	SS-TMPFL	60 mL in 1 BOTTLE, DISPENSING	SPRAY	60	3
58418-001-04	SS-TMPFL	120 mL in 1 BOTTLE, DISPENSING	SPRAY	120	3
58418-001-08	SS-TMPFL	240 mL in 1 BOTTLE, DISPENSING	SPRAY	240	3
58418-001-10	SS-TMPFL	10 mL in 1 BOTTLE, SPRAY	SPRAY	10	3
58418-001-12	SS-TMPFL	360 mL in 1 BOTTLE, PUMP	SPRAY	360	3
58418-001-16	SS-TMPFL	480 mL in 1 BOTTLE, PUMP	SPRAY	480	3
58418-001-25	SS-TMPFL	960000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	SPRAY	960000	3
58418-001-28	SS-TMPFL	3840 mL in 1 BOTTLE, PUMP	SPRAY	3840	3
58418-001-32	SS-TMPFL	1228800 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	SPRAY	1228800	3
58418-001-64	SS-TMPFL	1920 mL in 1 BOTTLE, PUMP	SPRAY	1920	3
58418-001-70	SS-TMPFL	211200 mL in 1 DRUM	SPRAY	211200	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58418-001	SS-TMPFL (BS SPF30 SPRAY - DL) SPRAY [TROPICAL ENTERPRISES INTERNATIONAL, INC.]	3	Legacy NDC, 12 package rows	20200716_70ac6e5f-2fca-733a-e053-2a91aa0aaf5b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58418-001-01	58418000101	30 mL in 1 BOTTLE, DISPENSING (58418-001-01)	30 ml	2018-10-01	0000-00-00	No	No	Current
58418-001-02	58418000102	60 mL in 1 BOTTLE, DISPENSING (58418-001-02)	60 ml	2018-10-01	0000-00-00	No	No	Current
58418-001-04	58418000104	120 mL in 1 BOTTLE, DISPENSING (58418-001-04)	120 ml	2018-10-01	0000-00-00	No	No	Current
58418-001-08	58418000108	240 mL in 1 BOTTLE, DISPENSING (58418-001-08)	240 ml	2018-10-01	0000-00-00	No	No	Current
58418-001-10	58418000110	10 mL in 1 BOTTLE, SPRAY (58418-001-10)	10 ml	2018-10-01	0000-00-00	No	No	Current
58418-001-12	58418000112	360 mL in 1 BOTTLE, PUMP (58418-001-12)	360 ml	2018-10-01	0000-00-00	No	No	Current
58418-001-16	58418000116	480 mL in 1 BOTTLE, PUMP (58418-001-16)	480 ml	2018-10-01	0000-00-00	No	No	Current
58418-001-25	58418000125	960000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (58418-001-25)	960000 ml	2020-04-24	0000-00-00	No	No	Current
58418-001-28	58418000128	3840 mL in 1 BOTTLE, PUMP (58418-001-28)	3840 ml	2018-10-01	0000-00-00	No	No	Current
58418-001-32	58418000132	1228800 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (58418-001-32)	1228800 ml	2018-10-01	0000-00-00	No	No	Current
58418-001-64	58418000164	1920 mL in 1 BOTTLE, PUMP (58418-001-64)	1920 ml	2018-10-01	0000-00-00	No	No	Current
58418-001-70	58418000170	211200 mL in 1 DRUM (58418-001-70)	211200 ml	2018-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL	Tropical Enterprises International, Inc. \| Tropiical Enterprises International, Inc.	2020-03-08	HUMAN OTC DRUG LABEL	3