FDA.reportPublic FDA data

Shelter Tinted

Manufacturer
Philosophy, Inc. | Philosophy Inc for BioTech Research Labs
Effective date
2010-02-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:26:06

Key Label Information#

Other Label Information

INACTIVE INGREDIENT SECTION

WATER (AQUA) C12-15 ALKYL BENZOATE CYCLOPENTASILOXANE GLYCERIN STEARETH-21 DIMETHICONE METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER BEHENYL ALCOHOL HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER DIMETHICONE CROSSPOLYMER STEARETH-2 RETINYL PALMITATE PHYTOSTEROLS TOCOTRIENOLS TOCOPHEROL SQUALENE ORYZA SATIVA (RICE) BRAN WAX PALMITOYL OLIGOPEPTIDE PALMITOYL TETRAPEPTIDE-7 RUBUS FRUITICOSUS (BLACKBERRY) LEAF EXTRACT MELANIN LAVANDULA AUGUSTIFOLIA (LAVENDER) OIL ALOE BARBADENSIS LEAF JUICE MALTODEXTRIN CARBOMER BUTYLENE GLYCOL POLYSORBATE 20 SIMETHICONE ALUMINA SORBITAN LAURATE DISODIUM EDTA CHLORPHENESIN PHENOXYETHANOL TRIETHOXYCAPRYLYLSILANE IRON OXIDES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Label Images#

TINTED
TINTED

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 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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
octinoxateACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
octinoxateACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
TITANIUMACTIVE MOIETYD1JT611TNE1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69331
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
CARBOMER 934INACTIVE INGREDIENTZ135WT92081
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DOCOSANOLINACTIVE INGREDIENT9G1OE216XY1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
ENGLISH LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D1
METHYL METHACRYLATEINACTIVE INGREDIENT196OC776881
OCTYLTRIETHOXYSILANEINACTIVE INGREDIENTLDC331P08E1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
RICE BRANINACTIVE INGREDIENTR60QEP13IC1
RUBUS FRUTICOSUS LEAFINACTIVE INGREDIENTYQ2S06L8S91
SORBITAN MONOLAURATEINACTIVE INGREDIENT6W9PS8B71J1
SQUALENEINACTIVE INGREDIENT7QWM220FJH1
STEARETH-2INACTIVE INGREDIENTV56DFE46J51
STEARETH-21INACTIVE INGREDIENT53J3F32P581
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50184-470050184-4700-1, 50184-4700-2

Ingredients#

Name, UNII, Kind table
NameUNIIKind
octinoxate4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERINPDC6A3C0OXIACT
STEARETH-2153J3F32P58IACT
DIMETHICONE92RU3N3Y1OIACT
METHYL METHACRYLATE196OC77688IACT
DOCOSANOL9G1OE216XYIACT
STEARETH-2V56DFE46J5IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
SQUALENE7QWM220FJHIACT
RICE BRANR60QEP13ICIACT
RUBUS FRUTICOSUS LEAFYQ2S06L8S9IACT
ENGLISH LAVENDER OILZBP1YXW0H8IACT
ALOE VERA LEAFZY81Z83H0XIACT
MALTODEXTRIN7CVR7L4A2DIACT
CARBOMER 934Z135WT9208IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
POLYSORBATE 207T1F30V5YHIACT
ALUMINUM OXIDELMI26O6933IACT
SORBITAN MONOLAURATE6W9PS8B71JIACT
EDETATE DISODIUM7FLD91C86KIACT
CHLORPHENESINI670DAL4SZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
OCTYLTRIETHOXYSILANELDC331P08EIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT

Complete SPL Sections#

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

WATER (AQUA) C12-15 ALKYL BENZOATE CYCLOPENTASILOXANE GLYCERIN STEARETH-21 DIMETHICONE METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER BEHENYL ALCOHOL HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER DIMETHICONE CROSSPOLYMER STEARETH-2 RETINYL PALMITATE PHYTOSTEROLS TOCOTRIENOLS TOCOPHEROL SQUALENE ORYZA SATIVA (RICE) BRAN WAX PALMITOYL OLIGOPEPTIDE PALMITOYL TETRAPEPTIDE-7 RUBUS FRUITICOSUS (BLACKBERRY) LEAF EXTRACT MELANIN LAVANDULA AUGUSTIFOLIA (LAVENDER) OIL ALOE BARBADENSIS LEAF JUICE MALTODEXTRIN CARBOMER BUTYLENE GLYCOL POLYSORBATE 20 SIMETHICONE ALUMINA SORBITAN LAURATE DISODIUM EDTA CHLORPHENESIN PHENOXYETHANOL TRIETHOXYCAPRYLYLSILANE IRON OXIDES

OTC - ASK DOCTOR SECTION

OTC - ASK DOCTOR SECTION

ASK DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS

OTC - WHEN USING SECTION

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT. KEEP OUT OF EYES, RINSE WITH WATER TO REMOVE.

OTC - STOP USE SECTION

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IS RASH OCCURS AND LASTS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN, IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CENTER RIGHT AWAY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Source Document#

Source XML