Hawaiian Tropic Lip Balm Sunscreen SPF 25

Product NDC: 63354-902
11-digit product format: 633540902
Labeler code: 63354
Product ID: 63354-902_b6387d2a-f963-5c1b-e053-2a95a90a83eb
Type: HUMAN OTC DRUG
Nonproprietary name: AVOBENZONE,OCTISALATE,OCTOCRYLENE
Dosage form: STICK
Route: TOPICAL
Labeler: Edgewell Personal Care Brands LLC
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-12-15
Marketing end: 0000-00-00
Substance: AVOBENZONE; OCTOCRYLENE; OCTISALATE
Active strength: 3 g/100g; g/100g; g/100g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63354-902		D	Discontinued by firm		2026-10-15
excluded package	package	63354-902	63354-902-61	D	Discontinued by firm		2026-10-15

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 · 6 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
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63354-902-61	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63354-902-61	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63354-902-61	`bd6a592717d7…`	`303034d00443…`

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
63354-902-61	2023-10-24	C162847	48780-1	d6a99b39-4c57-a426-e053-dadaa90af4c2	b6387d2a-f962-5c1b-e053-2a95a90a83eb
63354-902-61	2022-01-28	C162847	48780-1	d6a99b39-4c57-a426-e053-dadaa90af4c2	b6387d2a-f962-5c1b-e053-2a95a90a83eb

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63354-902	HAWAIIAN TROPIC LIP BALM SUNSCREEN SPF 25 (AVOBENZONE,OCTISALATE,OCTOCRYLENE) STICK [EDGEWELL PERSONAL CARE BRANDS LLC]	2	Legacy NDC	20231025_b6387d2a-f962-5c1b-e053-2a95a90a83eb.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63354-902-61	63354090261	3.97 g in 1 CYLINDER (63354-902-61)	3.97 g	2020-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hawaiian Tropic Lip Balm Sunscreen SPF 25 - Edgewell Personal Care Brands LLC	Edgewell Personal Care Brands LLC	2023-10-24	HUMAN OTC DRUG LABEL	2