FDA.reportPublic FDA data

ULTRASOL

Product NDC
59886-353
11-digit product format
598860353
Labeler code
59886
Product ID
59886-353_1a362e48-3a54-4443-97eb-5e996e920223
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Fischer Pharmaceuticals Ltd.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-06-10
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
2 g/100g; g/100g; g/100g; g/100g; g/100g
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59886-353-662020-01-31C16284748780-19d75b9d0-8938-f424-e053-dadaa90a57ceDr. Fischer ULTRASOL SPF30 KIDS Sunscreen Mousse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59886-353-66ULTRASOLKIDS200 g in 1 CANAEROSOL, FOAM2002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOXULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
OctinoxateACTIVE INGREDIENT4Y5P7MUD51ULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
OctisalateACTIVE INGREDIENT4X49Y0596WULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
OctocryleneACTIVE INGREDIENT5A68WGF6WMULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
OxybenzoneACTIVE INGREDIENT95OOS7VE0YULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
AvobenzoneACTIVE MOIETYG63QQF2NOXULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
OctinoxateACTIVE MOIETY4Y5P7MUD51ULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
OctisalateACTIVE MOIETY4X49Y0596WULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
OctocryleneACTIVE MOIETY5A68WGF6WMULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
OxybenzoneACTIVE MOIETY95OOS7VE0YULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
ButaneINACTIVE INGREDIENT6LV4FOR43RULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
ButylparabenINACTIVE INGREDIENT3QPI1U3FV8ULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
ChlorphenesinINACTIVE INGREDIENTI670DAL4SZULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
EthylparabenINACTIVE INGREDIENT14255EXE39ULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
IsobutaneINACTIVE INGREDIENTBXR49TP611ULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
PanthenolINACTIVE INGREDIENTWV9CM0O67ZULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
PropaneINACTIVE INGREDIENTT75W9911L6ULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56ULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2
WaterINACTIVE INGREDIENT059QF0KO0RULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59886-353ULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2Legacy NDC, 1 package rows20100610_7d10e92a-1f9c-4ba9-8c56-7716eb53999b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
59886-353-6659886035366200 g in 1 CAN200 gHistorical