BB SPF20

Product NDC: 76354-450
Requested package NDC: 76354-450-28
11-digit product format: 763540450
Labeler code: 76354
Product ID: 76354-450_ed7d1a33-7a1b-8ab1-e053-2a95a90a6813
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE, OCTISALATE, OXYBENZONE
Dosage form: CREAM
Route: TOPICAL
Labeler: J. A. Cosmetics U.S. INC
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2019-10-20
Marketing end: 0000-00-00
Substance: OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength: 60 mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
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	76354-450	76354-450-28	D	Discontinued by firm		2026-10-20

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 · 9 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…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76354-450-28	BB SPF20	1 in 1 BOX	CREAM	1		7
76354-450-28	BB SPF20	28.5 mL in 1 BOTTLE	CREAM	28.5		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76354-450	BB SPF20 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [E.L.F. COSMETICS, INC]	7	Legacy NDC, 2 package rows	20241215_25b6dc60-7480-42cf-acd3-4155d6e57b1f.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76354-450-28	76354045028	1 BOTTLE in 1 BOX (76354-450-28) > 28.5 mL in 1 BOTTLE	1 bottle	2019-10-20	0000-00-00	No	No	Current