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

Label at a glance#

ProductShelter Tinted
Active ingredientoctinoxate, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
Label structure6 sections

Label contents#

Full prescribing 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

OTC - ASK DOCTOR SECTION

ASK DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

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

MM1MM1Enter section text here

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#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

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

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 4 of 5 · 295 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675POWDER, FOR SUSPENSION / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, EMULSION / INTRAVENOUS59 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
STEARETH-21STEARETH-2153J3F32P58LOTION / TOPICAL3 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / NASAL0.1 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii candidate
20 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / ORAL80 mgExact identifier — unii candidate
28 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208EMULSION / TOPICAL3405 mgExact identifier — unii candidate
14 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
STEARETH-21STEARETH-2153J3F32P58CREAM / TOPICAL3 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208ENEMA / RECTAL0.24 %w/vExact identifier — unii candidate
14 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SOLUTION / INTRAVENOUS30 mgExact identifier — unii candidate
28 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208SUSPENSION / ORAL288 mgExact identifier — unii candidate
14 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRABURSAL0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITAN MONOLAURATESORBITAN MONOLAURATE6W9PS8B71JTABLET, FILM COATED / ORAL800 mgExact identifier — unii candidate
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EFFERVESCENT / ORAL14404 mgExact identifier — unii candidate
15 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED, EXTENDED RELEASE / ORAL3.6 mgExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE / ORAL5 mgExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTSUSPENSION / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHLOTION / TOPICAL2000 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHPOWDER, FOR SUSPENSION / ORAL1.3 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, DELAYED RELEASE / ORAL37 mgExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / BUCCAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAMUSCULAR10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION / INTRAMUSCULAR1.62 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675LOTION / TOPICALNAExact identifier — unii candidate
21 equally ranked IID candidates
SORBITAN MONOLAURATESORBITAN MONOLAURATE6W9PS8B71JEMULSION / ORALNAExact identifier — unii candidate
12 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / ORAL24 mgExact identifier — unii candidate
20 equally ranked IID candidates
ENGLISH LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTFILM / BUCCAL0.27 mgExact identifier — unii candidate
20 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
SORBITAN MONOLAURATESORBITAN MONOLAURATE6W9PS8B71JSUSPENSION / ORAL2.5 mg/5mlExact identifier — unii candidate
12 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, EXTENDED RELEASE / ORAL5 mgExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE / ORAL14 mgExact identifier — unii candidate
20 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
50e7bd88-779b-424f-aa74-938a90603f7eea5676d8-e99e-4a4e-aae4-e59ddd20c7062010-02-11Exact identifier
spl id: 50e7bd88-779b-424f-aa74-938a90603f7e
spl set id: ea5676d8-e99e-4a4e-aae4-e59ddd20c706

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.