FDA.reportPublic FDA data

Shelter Tinted

Product NDC
50184-4700
11-digit product format
501844700
Labeler code
50184
Product ID
50184-4700_50e7bd88-779b-424f-aa74-938a90603f7e
Type
HUMAN OTC DRUG
Nonproprietary name
octinoxate, octisalate, oxybenzone, titanium dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Philosophy, Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2004-09-14
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE
Active strength
75 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50184-4700-22019-10-29C16284748780-1960f7f55-c422-8e05-e053-dbdaa90a074aDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50184-4700-1Shelter Tinted56.7 g in 1 TUBECREAM56.71
50184-4700-2Shelter Tinted1 in 1 BOXCREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
octinoxateACTIVE INGREDIENT4Y5P7MUD51SHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
octinoxateACTIVE MOIETY4Y5P7MUD51SHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
TITANIUMACTIVE MOIETYD1JT611TNESHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1SHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933SHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RASHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208SHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
DOCOSANOLINACTIVE INGREDIENT9G1OE216XYSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
ENGLISH LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8SHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
METHYL METHACRYLATEINACTIVE INGREDIENT196OC77688SHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
OCTYLTRIETHOXYSILANEINACTIVE INGREDIENTLDC331P08ESHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
RICE BRANINACTIVE INGREDIENTR60QEP13ICSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
RUBUS FRUTICOSUS LEAFINACTIVE INGREDIENTYQ2S06L8S9SHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
SORBITAN MONOLAURATEINACTIVE INGREDIENT6W9PS8B71JSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
SQUALENEINACTIVE INGREDIENT7QWM220FJHSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
STEARETH-2INACTIVE INGREDIENTV56DFE46J5SHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
STEARETH-21INACTIVE INGREDIENT53J3F32P58SHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50184-4700SHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1Legacy NDC, 2 package rows20101012_ea5676d8-e99e-4a4e-aae4-e59ddd20c706.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50184-4700-15018447000156.7 g in 1 TUBE56.7 gHistorical
50184-4700-2501844700021 in 1 BOXHistorical