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

MM1Enter section text here

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50184-4700-2	2019-10-29	C162847	48780-1	960f7f55-c422-8e05-e053-dbdaa90a074a	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50184-4700-1	Shelter Tinted	56.7 g in 1 TUBE	CREAM	56.7		1
50184-4700-2	Shelter Tinted	1 in 1 BOX	CREAM	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50184-4700	SHELTER TINTED (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]	1	Legacy NDC, 2 package rows	20101012_ea5676d8-e99e-4a4e-aae4-e59ddd20c706.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	1
octinoxate	ACTIVE MOIETY	4Y5P7MUD51	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	1
TITANIUM	ACTIVE MOIETY	D1JT611TNE	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	1
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	1
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	1
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
DOCOSANOL	INACTIVE INGREDIENT	9G1OE216XY	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
ENGLISH LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	1
METHYL METHACRYLATE	INACTIVE INGREDIENT	196OC77688	1
OCTYLTRIETHOXYSILANE	INACTIVE INGREDIENT	LDC331P08E	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	1
RICE BRAN	INACTIVE INGREDIENT	R60QEP13IC	1
RUBUS FRUTICOSUS LEAF	INACTIVE INGREDIENT	YQ2S06L8S9	1
SORBITAN MONOLAURATE	INACTIVE INGREDIENT	6W9PS8B71J	1
SQUALENE	INACTIVE INGREDIENT	7QWM220FJH	1
STEARETH-2	INACTIVE INGREDIENT	V56DFE46J5	1
STEARETH-21	INACTIVE INGREDIENT	53J3F32P58	1
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Shelter Tinted
octinoxate, octisalate, oxybenzone, titanium dioxide
octinoxate
OCTISALATE
OXYBENZONE
TITANIUM DIOXIDE
TITANIUM
WATER
C12-15 ALKYL BENZOATE
CYCLOMETHICONE 5
GLYCERIN
STEARETH-21
DIMETHICONE
METHYL METHACRYLATE
DOCOSANOL
STEARETH-2
VITAMIN A PALMITATE
ALPHA-TOCOPHEROL
SQUALENE
RICE BRAN
RUBUS FRUTICOSUS LEAF
ENGLISH LAVENDER OIL
ALOE VERA LEAF
MALTODEXTRIN
CARBOMER 934
BUTYLENE GLYCOL
POLYSORBATE 20
ALUMINUM OXIDE
SORBITAN MONOLAURATE
EDETATE DISODIUM
CHLORPHENESIN
PHENOXYETHANOL
OCTYLTRIETHOXYSILANE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED

NDC Codes#

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

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
octinoxate	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
WATER	059QF0KO0R	IACT
C12-15 ALKYL BENZOATE	A9EJ3J61HQ	IACT
CYCLOMETHICONE 5	0THT5PCI0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
STEARETH-21	53J3F32P58	IACT
DIMETHICONE	92RU3N3Y1O	IACT
METHYL METHACRYLATE	196OC77688	IACT
DOCOSANOL	9G1OE216XY	IACT
STEARETH-2	V56DFE46J5	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
ALPHA-TOCOPHEROL	H4N855PNZ1	IACT
SQUALENE	7QWM220FJH	IACT
RICE BRAN	R60QEP13IC	IACT
RUBUS FRUTICOSUS LEAF	YQ2S06L8S9	IACT
ENGLISH LAVENDER OIL	ZBP1YXW0H8	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
CARBOMER 934	Z135WT9208	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
SORBITAN MONOLAURATE	6W9PS8B71J	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
CHLORPHENESIN	I670DAL4SZ	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
OCTYLTRIETHOXYSILANE	LDC331P08E	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERRIC OXIDE RED	1K09F3G675	IACT

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 5 of 5 · 295 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITAN MONOLAURATE	SORBITAN MONOLAURATE	6W9PS8B71J	CREAM / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	FILM, SOLUBLE / BUCCAL	0.07 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CYCLOMETHICONE 5	CYCLOMETHICONE 5	0THT5PCI0R	CREAM, AUGMENTED / TOPICAL		260 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, EXTENDED RELEASE / ORAL		3239 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / INTRAVENOUS	0.03 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	GEL / TOPICAL		30 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRALESIONAL	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER / RESPIRATORY (INHALATION)	0.04 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	POWDER, FOR SUSPENSION / ORAL		8000 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / ORAL		8 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / NASAL	2 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EFFERVESCENT / ORAL		32 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	DROPS / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TAMPON / VAGINAL	64.8 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
STEARETH-2	STEARETH-2	V56DFE46J5	CREAM / TOPICAL		643 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	SOLUTION / ORAL	1.05 mg/1ml		Exact identifier — unii candidate 10 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	SUSPENSION, EXTENDED RELEASE / ORAL	2.7 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / OPHTHALMIC		396 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TABLET / ORAL		17 mg	Exact identifier — unii candidate 28 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
50e7bd88-779b-424f-aa74-938a90603f7e			ea5676d8-e99e-4a4e-aae4-e59ddd20c706	2010-02-11		Exact 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.