FDA.reportPublic FDA data

UltrasolSunscreen

Product NDC
59886-326
11-digit product format
598860326
Labeler code
59886
Product ID
59886-326_bf0fa058-ac30-4641-8233-31441b298770
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octinoxate, Octisalate, Oxybenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
Fischer Pharmaceuticals Ltd
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-03-01
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
2 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
59886-326-772020-01-31C16284748780-19d75b9d0-2a6d-f424-e053-dadaa90a57ceDr. Fischer ULTRASOL Sunscreen Face Cream SPF34

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59886-326-77UltrasolSunscreenSunscreen Face Cream SPF 3450 g in 1 TUBECREAM502
59886-326-77UltrasolSunscreenSunscreen Face Cream SPF 341 in 1 BOXCREAM12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOXULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
OctinoxateACTIVE INGREDIENT4Y5P7MUD51ULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
OctisalateACTIVE INGREDIENT4X49Y0596WULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
OxybenzoneACTIVE INGREDIENT95OOS7VE0YULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
AvobenzoneACTIVE MOIETYG63QQF2NOXULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
OctinoxateACTIVE MOIETY4Y5P7MUD51ULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
OctisalateACTIVE MOIETY4X49Y0596WULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
OxybenzoneACTIVE MOIETY95OOS7VE0YULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
ButylparabenINACTIVE INGREDIENT3QPI1U3FV8ULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
ChlorphenesinINACTIVE INGREDIENTI670DAL4SZULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
EthylparabenINACTIVE INGREDIENT14255EXE39ULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
Isopropyl MyristateINACTIVE INGREDIENT0RE8K4LNJSULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3ULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2
WaterINACTIVE INGREDIENT059QF0KO0RULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59886-326ULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]2Legacy NDC, 2 package rows20100301_5d5141b0-f8e3-4fda-adfc-5d0f22d1e2b4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
59886-326-775988603267750 g in 1 TUBE50 gHistorical