FDA.reportPublic FDA data

CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER

Product NDC
49527-081
11-digit product format
495270081
Labeler code
49527
Product ID
49527-081_0828eba6-8d0e-9a5a-e063-6394a90a2fca
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE, OCTISALATE, and OXYBENZONE
Dosage form
LOTION
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-21
Substance
AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
30; 74; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
OCTINOXATE74 mg/mL
OCTISALATE50 mg/mL
OXYBENZONE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2e9463df-1c71-465f-9820-6cedefe07ad7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49527-081-012022-08-05C16284748780-1e4f33bdf-9ef5-d8a0-e053-dadaa90a6e4eCLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER
49527-081-012022-07-29C16284748780-1e4f33bdf-9ef5-d8a0-e053-dadaa90a6e4eCLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-081-01CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER1 in 1 CARTONLOTION15
49527-081-01CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER100 mL in 1 TUBELOTION1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-081CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [CLINIQUE LABORATORIES LLC]5Current NDC, Legacy NDC, 2 package rows20231021_2e9463df-1c71-465f-9820-6cedefe07ad7.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 118 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eclipse Body Non TintedZINC OXIDEDENISE BELL SKIN CARE396f56df-d0de-1344-e063-6294a90a46ea2025-12-15Exact identifier
application number: M020
Solar Shield TintedTITANIUM DIOXIDE, ZINC OXIDEDENISE BELL SKIN CARE396eb781-5947-3665-e063-6294a90a38dd2025-12-15Exact identifier
application number: M020
Sun Veil Illuminating Sunscreen SPF30ZINC OXIDEKoco Life LLC46001097-540e-65da-e063-6294a90af2992025-12-15WarningsExact identifier
application number: M020
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC3542d8d3-35a3-7d63-e063-6394a90a6fd12025-12-15Exact identifier
application number: M020
Mineral Primer non-tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC354357de-1a85-3bdb-e063-6294a90aa9a22025-12-15Exact identifier
application number: M020
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC35433254-1dc8-a8f3-e063-6394a90a29f02025-12-15Exact identifier
application number: M020
Sun Therapy SunscreenZINC OXIDESkin Therapy Studio LLC3544916b-3f63-3a7a-e063-6394a90ae5072025-12-15Exact identifier
application number: M020
Ultra Zinc Mineral Non TintedZINC OXIDESkin Therapy Studio LLC3545d603-3d01-c51d-e063-6394a90a15992025-12-15Exact identifier
application number: M020
Sun Therapy SunscreenZINC OXIDESkin Therapy Studio LLC357efafb-aa1c-0d69-e063-6394a90a51352025-12-15Exact identifier
application number: M020
Ultra Zinc Mineral Non TintedZINC OXIDESkin Therapy Studio LLC35806102-6919-116f-e063-6294a90ad9222025-12-15Exact identifier
application number: M020
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357eee3c-1c21-5efb-e063-6294a90a4bb72025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357e75ec-473e-df76-e063-6294a90a70c72025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f2f62-904a-2234-e063-6394a90aee722025-12-15Exact identifier
application number: M020
Superscreen Daytime Mineral SunscreenZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f915a-bd77-350b-e063-6294a90ad27f2025-12-15Exact identifier
application number: M020
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357ff025-84ad-6d77-e063-6394a90aad952025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY358021a2-235b-825b-e063-6394a90a76f52025-12-15Exact identifier
application number: M020
Superscreen Daytime Mineral SunscreenZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY35805e66-18e6-0e45-e063-6294a90afe582025-12-15Exact identifier
application number: M020
Ultra Zinc Physical DefenseZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35474ac4-8a9d-6a84-e063-6394a90a9bad2025-12-15Exact identifier
application number: M020
Ultra Zinc Physical DefenseZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER357e315e-8802-ad73-e063-6394a90a24952025-12-15Exact identifier
application number: M020
Tinted Physical DefenseTITANIUM DIOXIDE, ZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35477ed2-0875-58d5-e063-6294a90a3d5d2025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49527-081-01495270081011 TUBE in 1 CARTON (49527-081-01) / 100 mL in 1 TUBE1 tube2021-07-210000-00-00NoNoCurrent