CLINIQUE SUPERBALANCED SILK MAKEUP BROAD SPECTRUM SPF 15

Product NDC: 49527-052
11-digit product format: 495270052
Labeler code: 49527
Product ID: 49527-052_f0d7103a-e61b-cbf6-e053-2995a90aae58
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, and ZINC OXIDE
Dosage form: LIQUID
Route: TOPICAL
Labeler: CLINIQUE LABORATORIES LLC
Application: M020
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2016-07-15
Marketing end: 2023-11-30
Substance: OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 0 g/mL; g/mL; g/mL; g/mL
NDC exclude flag: No
Listing certified through: 0000-00-00
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	49527-052		D	Discontinued by firm		2026-10-21
excluded package	package	49527-052	49527-052-01	D	Discontinued by firm		2026-10-21

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 · 24 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49527-052-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49527-052-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49527-052-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49527-052-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49527-052-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49527-052-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49527-052-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49527-052-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49527-052-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49527-052-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49527-052-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49527-052-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
49527-052-01	2022-08-04	C162847	48780-1	e4f33bdf-9bd6-d8a0-e053-dadaa90a6e4e	CLINIQUE SUPERBALANCED SILK MAKEUP BROAD SPECTRUM SPF 15
49527-052-01	2022-07-29	C162847	48780-1	e4f33bdf-9bd6-d8a0-e053-dadaa90a6e4e	CLINIQUE SUPERBALANCED SILK MAKEUP BROAD SPECTRUM SPF 15

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 114 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zinc 20 mineral sunscreen face Plus body	ZINC OXIDE	PURE VITALITY SKIN AND BODY, INC	36985373-22dd-2232-e063-6394a90a76fb	2025-12-16		Exact identifier application number: M020
Matte Defense Mineral Sunscreen non tinted	TITANIUM DIOXIDE, ZINC OXIDE	PURE VITALITY SKIN AND BODY, INC	3698090a-1639-00f9-e063-6394a90a7dd1	2025-12-16		Exact identifier application number: M020
Daily Replenish mineral sunscreen	ZINC OXIDE	PURE VITALITY SKIN AND BODY, INC	3698d309-b9bf-e197-e063-6294a90af5a1	2025-12-16		Exact identifier application number: M020
Zinc 20 mineral sunscreen face Plus body	ZINC OXIDE	PURE VITALITY SKIN AND BODY, INC	3698f29e-5d80-94af-e063-6394a90a0489	2025-12-16		Exact identifier application number: M020
Tinted Mineral Primer SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	JOSEPHINA RAMIREZ	365cf2be-8862-3622-e063-6394a90ac4e3	2025-12-16		Exact identifier application number: M020
SANCTUARY Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CHAMPAGNE APOTHECARY LLC	365ca99c-c878-1f4b-e063-6394a90a1f53	2025-12-16		Exact identifier application number: M020
Tinted Mineral Defense SPF 40	ZINC OXIDE	JOSEPHINA RAMIREZ	365d299a-5886-5597-e063-6394a90a336c	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MILL VALLEY DERMATOLOGY, INC.	3b171a89-c757-47a1-e063-6294a90a7a64	2025-12-16	Warnings	Exact identifier application number: M020
Tinted BB Cream	ZINC OXIDE	Eco Esthetics LLC	38f3e618-59e1-4504-e063-6394a90afa55	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	ZINC OXIDE	MADRE TIERRA, INC.	3f697463-d3db-7b73-e063-6394a90ac222	2025-12-16	Warnings	Exact identifier application number: M020
Non-Tinted Replenishing Daily Protection	ZINC OXIDE	MADRE TIERRA, INC.	3f69d6f3-454b-e60a-e063-6394a90a8781	2025-12-16	Warnings	Exact identifier application number: M020
Mineral Sunscreen	ZINC OXIDE	ISIS GONZALEZ	3f68b2ea-be23-100d-e063-6294a90a8b37	2025-12-16	Warnings	Exact identifier application number: M020
Mineral Sunscreen	ZINC OXIDE	ISIS GONZALEZ	3f682b78-e1c9-e174-e063-6294a90a17ed	2025-12-16	Warnings	Exact identifier application number: M020
Silk Screen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Skin Science Institute Inc	36c3793a-ccb5-1e5f-e063-6294a90ad44f	2025-12-16		Exact identifier application number: M020
Silk Screen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Skin Science Institute Inc	36c3a721-6be1-3f7f-e063-6394a90a522f	2025-12-16		Exact identifier application number: M020
True Tone Tinted	TITANIUM DIOXIDE, ZINC OXIDE	That Face PLLC	36c2bb0e-479d-89cd-e063-6294a90aa3d4	2025-12-16		Exact identifier application number: M020
True Tone Non Tinted	ZINC OXIDE	That Face PLLC	36c2f263-67cf-e8cf-e063-6394a90ad81f	2025-12-16		Exact identifier application number: M020
Tinted Daily Protection Sunscreen	ZINC OXIDE	Kemmi Lee Skin Science	37ef5a05-54d2-a8e4-e063-6394a90a8e48	2025-12-16		Exact identifier application number: M020
Aquaphor Lip Repair Stick and Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,	Beiersdorf Inc	d469bddf-90d4-7b1c-e053-2a95a90a1ed9	2025-12-16	Warnings	Exact identifier application number: M020
Eucerin Daily Protection Face	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	Beiersdorf Inc	76403f03-aee9-4c0b-b331-f79b6953118c	2025-12-16	Warnings	Exact identifier application number: M020

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
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49527-052-01	49527005201	1 BOTTLE in 1 CARTON (49527-052-01) > 30 mL in 1 BOTTLE	1 bottle	2016-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLINIQUE SUPERBALANCED SILK MAKEUP BROAD SPECTRUM SPF 15	CLINIQUE LABORATORIES LLC \| Estee Lauder Companies Inc. \| PALC \| Estee Lauder Cosmetics Ltd. \| Whitman Laboratories Ltd. \| Estee Lauder N.V. \| The Estee Lauder Inc \| Northtec LLC \| PADC 1	2023-04-27	HUMAN OTC DRUG LABEL	8