FDA.reportPublic FDA data

Sunsect Insect Repellent Sunscreen

Product NDC
57595-001
11-digit product format
575950001
Labeler code
57595
Product ID
57595-001_bfad4f43-3418-4a2a-9acf-483a688abbb0
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, oxybenzone, octisalate
Dosage form
LOTION
Route
TOPICAL
Labeler
Iguana LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-06-01
Marketing end
0000-00-00
Substance
OCTISALATE; OCTINOXATE; OXYBENZONE; DIETHYLTOLUAMIDE
Active strength
5 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57595-001-012020-09-27C16284748780-1ab0e2407-3440-f274-e053-dbdaa90a6471Drug Facts
57595-001-022020-09-27C16284748780-1ab0e2407-3440-f274-e053-dbdaa90a6471Drug Facts
57595-001-032020-09-27C16284748780-1ab0e2407-3440-f274-e053-dbdaa90a6471Drug Facts
57595-001-042020-09-27C16284748780-1ab0e2407-3440-f274-e053-dbdaa90a6471Drug Facts
57595-001-012020-09-25C16284748780-1ab0e2407-3440-f274-e053-dbdaa90a6471Drug Facts
57595-001-022020-09-25C16284748780-1ab0e2407-3440-f274-e053-dbdaa90a6471Drug Facts
57595-001-032020-09-25C16284748780-1ab0e2407-3440-f274-e053-dbdaa90a6471Drug Facts
57595-001-042020-09-25C16284748780-1ab0e2407-3440-f274-e053-dbdaa90a6471Drug Facts
57595-001-012020-07-22C16284748780-1ab0e2407-3440-f274-e053-dbdaa90a6471Drug Facts
57595-001-022020-07-22C16284748780-1ab0e2407-3440-f274-e053-dbdaa90a6471Drug Facts
57595-001-032020-07-22C16284748780-1ab0e2407-3440-f274-e053-dbdaa90a6471Drug Facts
57595-001-042020-07-22C16284748780-1ab0e2407-3440-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57595-001-01Sunsect Insect Repellent Sunscreen59 g in 1 BOTTLE, PLASTICLOTION592
57595-001-02Sunsect Insect Repellent Sunscreen118 g in 1 BOTTLE, PLASTICLOTION1182
57595-001-03Sunsect Insect Repellent Sunscreen3672 g in 1 BOTTLE, PUMPLOTION36722
57595-001-04Sunsect Insect Repellent Sunscreen9 g in 1 PACKETLOTION92
57595-001-04Sunsect Insect Repellent Sunscreen50 in 1 BOXLOTION502

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIETHYLTOLUAMIDEACTIVE INGREDIENTFB0C1XZV4YSUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
OCTISALATEACTIVE INGREDIENT4X49Y0596WSUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YSUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
DIETHYLTOLUAMIDEACTIVE MOIETYFB0C1XZV4YSUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
OCTISALATEACTIVE MOIETY4X49Y0596WSUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YSUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT809Y72KV36SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ESUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
CarrageenanINACTIVE INGREDIENT5C69YCD2YJSUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
CITRONELLA OILINACTIVE INGREDIENTQYO8Q067D0SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
DIETHANOLAMINE CETYL PHOSPHATEINACTIVE INGREDIENT4UG0316V9SSUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
TRICONTANYL POVIDONEINACTIVE INGREDIENTN0SS3Q238DSUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RSUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57595-001SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]2Legacy NDC, 5 package rows20150701_6ccdc093-8af9-4bd8-84b0-f229fccd2f1c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
57595-001-015759500010159 g in 1 BOTTLE, PLASTIC59 gHistorical
57595-001-0257595000102118 g in 1 BOTTLE, PLASTIC118 gHistorical
57595-001-03575950001033672 g in 1 BOTTLE, PUMP3672 gHistorical
57595-001-04575950001049 g in 1 PACKET9 gHistorical