SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE plus 1ST SIGNS OF AGE MULTI-CORRECTING

Product NDC: 49527-075
11-digit product format: 495270075
Labeler code: 49527
Product ID: 49527-075_f0d8b591-7ead-7fc7-e053-2a95a90a04e6
Type: HUMAN OTC DRUG
Nonproprietary name: AVOBENZONE and OCTISALATE
Dosage form: CREAM
Route: TOPICAL
Labeler: CLINIQUE LABORATORIES LLC
Application: M020
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2019-11-21
Marketing end: 0000-00-00
Substance: AVOBENZONE; OCTISALATE
Active strength: 0 g/mL; g/mL
NDC exclude flag: No
Listing certified through: 2024-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49527-075		I	Inactivated by FDA	2026-10-20
excluded package	package	49527-075	49527-075-01	I	Inactivated by FDA	2026-10-20
excluded package	package	49527-075	49527-075-02	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 · 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…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49527-075-01	2022-08-15	C162847	48780-1	e4f33bdf-9e69-d8a0-e053-dadaa90a6e4e	SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE + 1ST SIGNS OF AGE MULTI-CORRECTING CREAM
49527-075-01	2022-07-29	C162847	48780-1	e4f33bdf-9e69-d8a0-e053-dadaa90a6e4e	SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE + 1ST SIGNS OF AGE MULTI-CORRECTING CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49527-075-01	SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE plus 1ST SIGNS OF AGE MULTI-CORRECTING	1 in 1 CARTON	CREAM	1	9
49527-075-01	SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE plus 1ST SIGNS OF AGE MULTI-CORRECTING	50 mL in 1 JAR	CREAM	50	9
49527-075-02	SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE plus 1ST SIGNS OF AGE MULTI-CORRECTING	7 mL in 1 TUBE	CREAM	7	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49527-075	SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING (AVOBENZONE AND OCTISALATE) CREAM [CLINIQUE LABORATORIES LLC]	9	Legacy NDC, 3 package rows	20241226_53c03415-5a4c-492a-b632-56699c042bec.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 127 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	BASS & KLASS, INC	36af24e2-015a-a9a7-e063-6294a90a2fce	2025-12-15		Exact identifier application number: M020
Tinted Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BASS & KLASS, INC	36add3a3-f1ff-3986-e063-6394a90ab7fe	2025-12-15		Exact identifier application number: M020
Antioxidant Mineral Sunscreen Plus Primer Lightly Tinted	ZINC OXIDE	True Beauty Brows & Skin Care	37dc70ba-a6bb-fe09-e063-6394a90a5129	2025-12-15		Exact identifier application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	bcbab676-fbe2-f0cc-e053-2a95a90ad4d2	2025-12-15	Warnings	Exact identifier application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF100	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	f14cf2b8-b110-1210-e053-2995a90a0102	2025-12-15	Warnings	Exact identifier application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF100	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	f1504311-4865-5499-e053-2995a90acdcd	2025-12-15	Warnings	Exact identifier application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SUNSCREEN SPF100	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	f14d70f1-440b-900d-e053-2995a90a30a0	2025-12-15	Warnings	Exact identifier application number: M020
REVERSE Brightening Defense Fluid	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Rodan & Fields	dc230e1e-bfb8-4d7c-bad5-bff77d78220e	2025-12-15	Warnings	Exact identifier application number: M020
COOLA BARE REPUBLIC MINERAL SPORT SPF50	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	bbf15e58-c160-d599-e053-2a95a90a0696	2025-12-14	Warnings	Exact identifier application number: M020
Mineral Sunscreen Stick SPF 50 Fragrance-Free	ZINC OXIDE	COOLA LLC	ee8706b0-ad42-403a-be7c-b660f040a244	2025-12-14	Warnings	Exact identifier application number: M020
COOLA CLASSIC SUNSCREEN FRAGRANCE FREE	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	cfc21b1a-4a26-1573-e053-2995a90a2d50	2025-12-14	Warnings	Exact identifier application number: M020
Kopari Sunglaze Sheer Body Mist Sunscreen SPF42	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kopari Beauty	7c96b799-e24d-473f-8f0a-3fad83d5ed48	2025-12-14	Warnings	Exact identifier application number: M020
WOODSLEEP Sunscreen Balm	TITANIUM DIOXIDE	Shantou Woodsleep Biotechnology Co., Ltd.	45cfc7ed-34a6-1f45-e063-6394a90a902b	2025-12-13	Warnings	Exact identifier application number: M020
Universkin by Alma Daily Mineral Serum Broad Spectrum SPF50	ZINC OXIDE 24%	UNIVERSKIN	45d242de-cbd8-e7ea-e063-6394a90aaebf	2025-12-13	Warnings	Exact identifier application number: M020
Mineral Sunscreen	ZINC OXIDE SPF 50	ALAINA HEALTHCARE PRIVATE LIMITED	b7847d4f-2517-4b58-8e31-676c9d6e484d	2025-12-12	Warnings	Exact identifier application number: M020
Lip Protecting	TITANIUM DIOXIDE, ZINC OXIDE	JOHANNA'S SKIN CARE	3544b8f2-2651-4c01-e063-6394a90ae53d	2025-12-12		Exact identifier application number: M020
Tinted SPF40	TITANIUM DIOXIDE, ZINC OXIDE	JOHANNA'S SKIN CARE	3544faa1-ebdf-5dbd-e063-6394a90a7631	2025-12-12		Exact identifier application number: M020
Replenishing Daily Protection Tinted	ZINC OXIDE	SOLUTIONS SKIN CARE LLC	40323dfa-29e4-1464-e063-6294a90aa65c	2025-12-12	Warnings	Exact identifier application number: M020
Zinc 20Percent SPF 40	ZINC OXIDE	JOHANNA'S SKIN CARE	3545ed3e-b42f-d29d-e063-6394a90a8efe	2025-12-12		Exact identifier application number: M020
Replenishing Daily Protection Non-Tinted	ZINC OXIDE	SOLUTIONS SKIN CARE LLC	40332cf3-e4e5-0c00-e063-6394a90a683d	2025-12-12	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
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
49527-075-01	49527007501	1 JAR in 1 CARTON (49527-075-01) > 50 mL in 1 JAR	1 jar	2019-11-21	0000-00-00	No	No	Current
49527-075-02	49527007502	7 mL in 1 TUBE (49527-075-02)	7 ml	2019-11-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE + 1ST SIGNS OF AGE MULTI-CORRECTING CREAM	CLINIQUE LABORATORIES LLC \| Estee Lauder Companies Inc. \| PALC \| The Estee Lauder Inc \| NORTHTEC LLC	2024-12-25	HUMAN OTC DRUG LABEL	9