FDA.reportPublic FDA data

SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION

Product NDC
49527-077
11-digit product format
495270077
Labeler code
49527
Product ID
49527-077_0817d141-8c8f-3e19-e063-6394a90a8311
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, and OCTISALATE
Dosage form
CREAM
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-28
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
30; 50; 50 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
SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE50 mg/mL
OCTISALATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal 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
b0e9edb6-0bc6-4e5b-93ab-b3bdbf3f8be0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
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
49527-077-012022-08-05C16284748780-1e4f33bdf-a793-d8a0-e053-dadaa90a6e4eSUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE + 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION
49527-077-012022-07-29C16284748780-1e4f33bdf-a793-d8a0-e053-dadaa90a6e4eSUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE + 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-077-01SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION1 in 1 CARTONCREAM17
49527-077-01SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION50 mL in 1 JARCREAM507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-077SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION (AVOBENZONE, HOMOSALATE, AND OCTISALATE) CREAM [CLINIQUE LABORATORIES LLC]7Current NDC, Legacy NDC, 2 package rows20231020_b0e9edb6-0bc6-4e5b-93ab-b3bdbf3f8be0.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 49 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sunscreen CreamAVOBENZONE, OCTISALATE, OCTOCRYLENEJiangsu Senwo Medical Technology Co., Ltd.4e615757-76b1-8f34-e063-6394a90a280a2026-04-01WarningsExact identifier
application number: M020
All Good Mineral Sport Sunscreen Sunstick SPF 30ZINC OXIDEElemental Herbs, Inc.4e67b76e-b791-4e26-e063-6294a90aa9912026-04-01WarningsExact identifier
application number: M020
All Good Coconut Mineral Sunscreen Sunstick SPF 30ZINC OXIDEElemental Herbs, Inc.4e67e89b-a7be-a540-e063-6294a90a6d8f2026-04-01WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAYAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEShiseido Americas Corporationcad3a446-36a8-4146-81b5-1cc8d65abf142026-04-01WarningsExact identifier
application number: M020
MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN BRIGHTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEForest Avenue Co., Ltd.8de4ec46-f60a-4c51-a16e-9140150e21622026-04-01WarningsExact identifier
application number: M020
ChapStick Moisturizer Cool Mint SPF 15SPF 15 LIP PROTECTANTSuave Brands Co., LLC42f50497-ded1-6863-e063-6294a90a39c82026-03-31WarningsExact identifier
application number: M020
Purito Sunday Adventure Sunscreen SPF 50, 50 mLAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHinaturebf16f535-97fc-4fd8-9310-8b6bbc82baae2026-03-31WarningsExact identifier
application number: M020
spf 50 mineral powder sunscreenTITANIUM DIOXIDE, ZINC OXIDESmalls Brand LLC DBA Roe Wellnessf8762dd1-0484-74ea-e053-6294a90ac1122026-03-31WarningsExact identifier
application number: M020
Badger SPF 30 Face Mineral SunscreenZINC OXIDEW.S. Badger Company, Inc.14a9b605-f1f0-00e5-e063-6394a90a5a512026-03-31WarningsExact identifier
application number: M020
Covergirl cgsmoothers BB Tinted Moisturizer Broad Spectrum SPF 21 (all shades)OCTINOXATE AND ZINC OXIDENoxell Corporation38bba282-b4f7-4374-8732-419400b1cc502026-03-31WarningsExact identifier
application number: M020
SeranovaTM ULTRALIGHT SPF50 SERUMSERANOVATM ULTRALIGHT SPF50 SERUMGuangzhou Ariel Biotech Co., Ltd.4e5d716d-2b2d-d42f-e063-6294a90a1e522026-03-31WarningsExact identifier
application number: M020
ageLOC Tru Face Radiant DayAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENENSE Products, Inc.3e9a0b39-4351-41df-81b2-88c1c15c0db22026-03-31WarningsExact identifier
application number: M020
Sunright Solar Screen Mineral Face SunscreenZINC OXIDENSE Products, Inc.93a32040-3a47-4d6f-baa1-5a4595bef4102026-03-31WarningsExact identifier
application number: M020
Lancome Paris Renergie HPN 300 Peptide Sunscreen Broad Spectrum SPF 25 High-Performance DayAVOBENZONE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc28f500e2-41d1-4747-8f26-3f6f8cc1b5832026-03-30WarningsExact identifier
application number: M020
Lancome Paris Renergie HPN 300 Peptide Sunscreen Broad Spectrum SPF 25 High-Performance DayAVOBENZONE, OCTISALATE, AND OCTOCRYLENESICOS ET CIEdd448b7a-2554-4dfc-9eb3-ec3486ec61972026-03-30WarningsExact identifier
application number: M020
ANUA MINERAL WEIGHTLESS FINISH SUNSCREENZINC OXIDEThefounders4e37d291-84fb-252a-e063-6294a90acd1f2026-03-30WarningsExact identifier
application number: M020
Beyond Glow Tinted Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDETHE AVON COMPANY4e43bea2-247d-fe11-e063-6294a90a33a32026-03-30WarningsExact identifier
application number: M020
Abib Quick sunstick Protection barHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONEFOURCOMPANY CO., LTD.1a2ab632-643f-1aa9-e063-6394a90a0c052026-03-30WarningsExact identifier
application number: M020
ChapStick Classic Original MilitarySKIN PROTECTANT LIP BALMSuave Brands Co., LLC4514490b-f348-4526-e063-6294a90ad5052026-03-30WarningsExact identifier
application number: M020
ChapStick Moisturizer Black Cherry SPF 15SPF 15 SKIN PROTECTANTSuave Brands Co., LLC42f40978-51ca-f448-e063-6294a90acf312026-03-30WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49527-077-01495270077011 JAR in 1 CARTON (49527-077-01) / 50 mL in 1 JAR1 jar2020-01-280000-00-00NoNoCurrent