FDA.reportPublic FDA data

KARA VITA

Product NDC
68572-6018
11-digit product format
685726018
Labeler code
68572
Product ID
68572-6018_1a852d84-3f23-422a-bc5e-de37d07a6db3
Type
HUMAN OTC DRUG
Nonproprietary name
OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, and HOMOSALATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Kara Vita, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-10-15
Substance
AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
30; 60; 75; 50; 60 mg/g; mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
KARA VITA
Brand name suffix
Moisturizing Sunscreen with DNArescue
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
HOMOSALATE60 mg/g
OCTINOXATE75 mg/g
OCTISALATE50 mg/g
OXYBENZONE60 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4Y5P7MUD51, 4X49Y0596W, 95OOS7VE0Y

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68572-6018-42025-07-25C16284748780-19d75b9d0-1d4d-f424-e053-dadaa90a57ceKaravita Moisturizing SPF 29 Active with DNArescue™
68572-6018-42020-01-31C16284748780-19d75b9d0-1d4d-f424-e053-dadaa90a57ceKaravita Moisturizing SPF 29 Active with DNArescue™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68572-6018-4KARA VITAMoisturizing Sunscreen with DNArescue113 g in 1 BOTTLECREAM1133
68572-6018-4KARA VITAMoisturizing Sunscreen with DNArescue1 in 1 CARTONCREAM13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51KARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
HOMOSALATEACTIVE MOIETYV06SV4M95SKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51KARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0KARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
alcoholINACTIVE INGREDIENT3K9958V90MKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
dioctyl maleateINACTIVE INGREDIENTOD88G8439LKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
potassium cetyl phosphateINACTIVE INGREDIENT03KCY6P7UTKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
sorbitolINACTIVE INGREDIENT506T60A25RKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
trolamineINACTIVE INGREDIENT9O3K93S3TKKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RKARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68572-6018KARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]2Current NDC, Legacy NDC, 2 package rows20181120_2130e9ac-5946-4b00-94d0-a78fd1ccfd13.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68572-6018-4685726018041 BOTTLE in 1 CARTON (68572-6018-4) / 113 g in 1 BOTTLE1 bottle2015-10-15NoNoHistorical