ACWELL UV CUT Waterproof Sun

Product NDC: 71597-060
Requested package NDC: 71597-060-02
11-digit product format: 715970060
Labeler code: 71597
Product ID: 71597-060_7b0b5f71-f053-4727-97ae-8cb7c69cefe8
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE, HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: BNHCOSMETICS CO.,LTD.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2019-08-01
Marketing end: 0000-00-00
Substance: ZINC OXIDE; HOMOSALATE; OCTISALATE; TITANIUM DIOXIDE
Active strength: 5 g/50g; g/50g; g/50g; g/50g
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71597-060	71597-060-02	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71597-060-02	71597006002	1 CONTAINER in 1 CARTON (71597-060-02) > 50 g in 1 CONTAINER (71597-060-01)	1 container	2019-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZINC OXIDE - BNHCOSMETICS CO.,LTD. \| Kolmar Korea Co.,LTD. Gwanjeong Factory	BNHCOSMETICS CO.,LTD. \| Kolmar Korea Co.,LTD. Gwanjeong Factory	2019-09-02	HUMAN OTC DRUG LABEL	1

ACWELL UV CUT Waterproof Sun

NDC auxiliary status#

Observed NDC auxiliary status history#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#