Shelter

Manufacturer
Philosophy, Inc.
Effective date
2010-02-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:23:46

Label at a glance#

ProductShelter
Active ingredientOctinoxate, Octisalate, Oxybenzone, Titanium Dioxide
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octinoxate......7.5%

Octisalate.......5.0%

Oxybenzone...... 5.0%

Titanium Dioxide......1.2%

Inactive Ingredients

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 sative (rice) bran wax, palmitoyl oligopeptide, palmitoyl tetrapeptide-7, rubus fruticosus (blackberry) leaf extract, melanin, lavandula angustifolia (lavender) oil, aloe barbadensis leaf juice, maltodextrin, carbomer, butylene glycol, polysorbate 20, simethicone, alumina, sorbitan laurate, quercetin, diethylhexyl syringylidene malonate, capric caprylic triglycerides, disodium edta, chlorphenesin, phenoxyethanol.

Stop Use

OTC - ASK DOCTOR SECTION


STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

WHEN USING

OTC - WHEN USING SECTION

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

INDICATIONS

INDICATIONS & USAGE SECTION

HELPS PREVENT SUNBURN. HIGHER SPF GIVES MORE SUNBURN PROTECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

box artworkbox artwork

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50184-4800-22019-10-21C16284748780-1956f9ecf-bb7d-621f-e053-dbdaa90a74adActive Ingredients
50184-4800-42019-10-21C16284748780-1956f9ecf-bb7d-621f-e053-dbdaa90a74adActive Ingredients

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50184-4800-1Shelter56.7 g in 1 TUBECREAM56.71
50184-4800-2Shelter1 in 1 BOXCREAM11
50184-4800-3Shelter113.4 g in 1 TUBECREAM113.41
50184-4800-4Shelter1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50184-4800SHELTER (OCTINOXATE AND OCTISALATE AND OXYBENZONE AND TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]1Legacy NDC, 4 package rows20100301_b9acfee5-5956-41c1-8ef8-45f04890b28d.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

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50184-480050184-4800-1, 50184-4800-2, 50184-4800-3, 50184-4800-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

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
d57415b0-ed15-4226-9d41-184f96e1ca91b9acfee5-5956-41c1-8ef8-45f04890b28d2010-02-23Exact identifier
spl id: d57415b0-ed15-4226-9d41-184f96e1ca91
spl set id: b9acfee5-5956-41c1-8ef8-45f04890b28d

Reported adverse events (FAERS/openFDA)#

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