FDA.reportPublic FDA data

REPAIRWEAR

Product NDC
49527-017
11-digit product format
495270017
Labeler code
49527
Product ID
49527-017_32c42bda-e70e-fc0b-e063-6394a90a8614
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-05-02
Substance
OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Active strength
75; 35; 17 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
REPAIRWEAR
Brand name suffix
UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE75 mg/mL
OCTISALATE35 mg/mL
TITANIUM DIOXIDE17 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Y5P7MUD51, 4X49Y0596W, 15FIX9V2JP

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product 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
49527-017-012022-08-04C16284748780-19d75b9d0-f9be-f424-e053-dadaa90a57ceREPAIRWEAR UPLIFTING FIRMING CREAM BROAD SPECTRUM SPF 15 DRY
49527-017-012022-07-29C16284748780-19d75b9d0-f9be-f424-e053-dadaa90a57ceREPAIRWEAR UPLIFTING FIRMING CREAM BROAD SPECTRUM SPF 15 DRY
49527-017-012020-12-03C16284748780-19d75b9d0-f9be-f424-e053-dadaa90a57ceREPAIRWEAR UPLIFTING FIRMING CREAM BROAD SPECTRUM SPF 15 DRY
49527-017-012020-01-31C16284748780-19d75b9d0-f9be-f424-e053-dadaa90a57ceREPAIRWEAR UPLIFTING FIRMING CREAM BROAD SPECTRUM SPF 15 DRY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-017-01REPAIRWEARUPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY50 mL in 1 JARCREAM5010
49527-017-01REPAIRWEARUPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY1 in 1 CARTONCREAM110

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
OCTISALATEACTIVE MOIETY4X49Y0596WREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
acetyl hexapeptide-8INACTIVE INGREDIENTL4EL31FWILREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
ammonium acryloyldimethyltaurate/vp copolymerINACTIVE INGREDIENTW59H9296ZGREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
astrocaryum murumuru seed butterINACTIVE INGREDIENT12V64UPU6RREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
butylene glycolINACTIVE INGREDIENT3XUS85K0RAREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
c12-16 alcoholsINACTIVE INGREDIENTS4827SZE3LREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
caffeineINACTIVE INGREDIENT3G6A5W338EREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
caprylyl glycolINACTIVE INGREDIENT00YIU5438UREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
chlorella vulgarisINACTIVE INGREDIENTRYQ4R60M02REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
cholesterolINACTIVE INGREDIENT97C5T2UQ7JREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
cladosiphon okamuranusINACTIVE INGREDIENT2IJE0CH09JREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
clary sageINACTIVE INGREDIENTU3HSK5JC0QREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
di-c12-15 alkyl fumarateINACTIVE INGREDIENTA1CB3Z898PREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
docosanolINACTIVE INGREDIENT9G1OE216XYREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
ergothioneineINACTIVE INGREDIENTBDZ3DQM98WREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
FD&C red no. 4INACTIVE INGREDIENTX3W0AM1JLXREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
FD&C yellow no. 5INACTIVE INGREDIENTI753WB2F1MREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
guggulINACTIVE INGREDIENT34969JX79RREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
hexyldecyl stearateINACTIVE INGREDIENTOJX2P28Y14REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
hexylene glycolINACTIVE INGREDIENTKEH0A3F75JREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
high density polyethyleneINACTIVE INGREDIENTUG00KM4WR7REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
hyaluronate sodiumINACTIVE INGREDIENTYSE9PPT4THREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
icodextrinINACTIVE INGREDIENT2NX48Z0A9GREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
laminaria digitataINACTIVE INGREDIENT15E7C67EE8REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
litchi chinensis seedINACTIVE INGREDIENT9294024N9QREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
medium-chain triglyceridesINACTIVE INGREDIENTC9H2L21V7UREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
micaINACTIVE INGREDIENTV8A1AW0880REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
octyldodecyl neopentanoateINACTIVE INGREDIENTX8725R883TREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
palmitic acidINACTIVE INGREDIENT2V16EO95H1REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
peg-100 stearateINACTIVE INGREDIENTYD01N1999RREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
pentaerythrityl tetraethylhexanoateINACTIVE INGREDIENTXJ7052W897REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
pentylene glycolINACTIVE INGREDIENT50C1307PZGREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
potassium sorbateINACTIVE INGREDIENT1VPU26JZZ4REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
sorbitolINACTIVE INGREDIENT506T60A25RREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
tetrahexyldecyl ascorbateINACTIVE INGREDIENT9LBV3F07AZREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
waterINACTIVE INGREDIENT059QF0KO0RREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEEREPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-017REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES LLC]10Current NDC, Legacy NDC, 2 package rows20250416_07701e11-8a7e-44c5-b46e-5b48264eacad.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49527-017-01495270017011 JAR in 1 CARTON (49527-017-01) / 50 mL in 1 JAR1 jar2020-11-240000-00-00NoNoCurrent