FDA.reportPublic FDA data

CLINIQUE FOR MEN SUPER ENGERGIZER ANTI -FATIGUE HYDRATING Concentrate BROAD SPECTRUM SPF 25

Product NDC
49527-063
11-digit product format
495270063
Labeler code
49527
Product ID
49527-063_0799f11b-4622-0a97-e063-6394a90a17ed
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE and OCTISALATE
Dosage form
CREAM
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-01
Substance
AVOBENZONE; OCTISALATE
Active strength
30; 50 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 SUPER ENGERGIZER ANTI -FATIGUE HYDRATING Concentrate BROAD SPECTRUM SPF 25
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f1109f0e-ebf5-450e-8a4e-b314a91b2483Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49527-063-012022-08-04C16284748780-1e4f33bdf-aa00-d8a0-e053-dadaa90a6e4eCLINIQUE FOR MEN SUPER ENGERGIZER ANTI -FATIGUE HYDRATING CONCENTRATE BROAD SPECTRUM SPF 25
49527-063-012022-07-29C16284748780-1e4f33bdf-aa00-d8a0-e053-dadaa90a6e4eCLINIQUE FOR MEN SUPER ENGERGIZER ANTI -FATIGUE HYDRATING CONCENTRATE BROAD SPECTRUM SPF 25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-063-01CLINIQUE FOR MEN SUPER ENGERGIZER ANTI -FATIGUE HYDRATING Concentrate BROAD SPECTRUM SPF 251 in 1 CARTONCREAM17
49527-063-01CLINIQUE FOR MEN SUPER ENGERGIZER ANTI -FATIGUE HYDRATING Concentrate BROAD SPECTRUM SPF 2548 mL in 1 BOTTLECREAM487

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-063CLINIQUE FOR MEN SUPER ENGERGIZER ANTI -FATIGUE HYDRATING CONCENTRATE BROAD SPECTRUM SPF 25 (AVOBENZONE AND OCTISALATE) CREAM [CLINIQUE LABORATORIES LLC]7Current NDC, Legacy NDC, 2 package rows20231014_f1109f0e-ebf5-450e-8a4e-b314a91b2483.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 149 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare37643884-f186-fb54-e063-6394a90a450f2025-12-08Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8208b-7328-1891-e063-6294a90abdd92025-12-08Exact identifier
application number: M020
Protect Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8dedc-0575-9819-e063-6394a90afebf2025-12-08Exact identifier
application number: M020
Protect Mineral Stick ClearTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bfa392-dfec-bd8a-e063-6394a90acffa2025-12-08Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b9d646-e049-6781-e063-6294a90ab1012025-12-08Exact identifier
application number: M020
Protect 20 Zinc Oxide Mineral Sunscreen Non-TintedZINC OXIDEMelinda Menezes, M.D., Inc.35be70d5-aefe-fd6f-e063-6394a90ac4362025-12-08Exact identifier
application number: M020
Protect 20 Zinc Oxide Mineral Sunscreen TintedZINC OXIDEMelinda Menezes, M.D., Inc.35be17ce-c3a7-fd59-e063-6394a90ad11d2025-12-08Exact identifier
application number: M020
Protect Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35c044a6-90be-55f8-e063-6294a90aad482025-12-08Exact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 27 MEDIUMOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247ed877-2926-1fd9-e063-6394a90aa1532025-12-08WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMELOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f1ad4c-af9a-c998-e063-6294a90a15db2025-12-08WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 31 TANOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f37a57-47ce-4175-e063-6394a90a92ee2025-12-08WarningsExact identifier
application number: M020
RECHARGE Protect BlurTITANIUM DIOXIDE, ZINC OXIDERodan & Fields Beauty, LLCc787e3b9-33b1-4c47-95bd-b14cf65589382025-12-08WarningsExact identifier
application number: M020
Mineral Mist SPF-50TITANIUM DIOXIDE, ZINC OXIDETUBBY TODDdca54a19-af25-ce47-e053-2a95a90a22db2025-12-07WarningsExact identifier
application number: M020
Inblair Elevate SPF15 MoisturizerINBLAIR ELEVATE SPF15 MOISTURIZERGuangzhou Fantesy Biotechnology Co.,Ltd4567d413-d8cc-677b-e063-6294a90a1a422025-12-07WarningsExact identifier
application number: M020
HANCHOBIT Radiant Pink Tone Up Sun CreamTITANIUM DIOXIDEHANCHOYEANBIOTEC Co.,Ltd.45685047-166d-8af5-e063-6294a90aa7be2025-12-07WarningsExact identifier
application number: M020
EELHOE Moisturiser Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.454004c9-07fa-64ad-e063-6394a90a0c8a2025-12-06WarningsExact identifier
application number: M020
OUHOE Daily Exposure Lightweight SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.454301b6-21a6-6153-e063-6294a90a13662025-12-06WarningsExact identifier
application number: M020
OUHOE Cotton Soft Sun StickTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4543a43e-acf7-6759-e063-6394a90a2f532025-12-06WarningsExact identifier
application number: M020
OUHOE Centella Daily SunTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4544f3a3-8c52-ea54-e063-6394a90a7a9c2025-12-06WarningsExact identifier
application number: M020
EELHOE All Day Light Sunscreen MistTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.45323ca3-c706-dcb5-e063-6394a90a96f72025-12-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49527-063-01495270063011 BOTTLE in 1 CARTON (49527-063-01) / 48 mL in 1 BOTTLE1 bottle2018-10-010000-00-00NoNoCurrent