Shade Uvaguard

NDA 20045, held by Bayer Healthcare LLC. Avobenzone; Octinoxate; Oxybenzone.

As of Nov 13, 2026, NDA 20045 (Shade Uvaguard), held by Bayer Healthcare LLC, was first approved by FDA on Dec 7, 1992, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 7, 1992
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 7, 1992	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Shade Uvaguard3%;7.5%;3% · lotion;topical	Avobenzone; Octinoxate; Oxybenzone	DiscontinuedReference drug

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 22, 1996	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 1, 1993	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 10, 1993	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 19, 1993	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 7, 1992	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 20045
Drugs@FDA: Overview at FDA
Company: Bayer Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters