SHELTER TINTED - octinoxate, octisalate, oxybenzone, titanium dioxide cream 
Philosophy, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

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

ASK DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS

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

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

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

MM1Enter section text here

SHELTER TINTED 
octinoxate, octisalate, oxybenzone, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-4700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARETH-21 (UNII: 53J3F32P58)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYL METHACRYLATE (UNII: 196OC77688)  
DOCOSANOL (UNII: 9G1OE216XY)  
STEARETH-2 (UNII: V56DFE46J5)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
SQUALENE (UNII: 7QWM220FJH)  
RICE BRAN (UNII: R60QEP13IC)  
RUBUS FRUTICOSUS LEAF (UNII: YQ2S06L8S9)  
ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CARBOMER 934 (UNII: Z135WT9208)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OCTYLTRIETHOXYSILANE (UNII: LDC331P08E)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50184-4700-21 in 1 BOX
1NDC:50184-4700-156.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/14/2004
Labeler - Philosophy, Inc. (948102256)
Establishment
NameAddressID/FEIBusiness Operations
Philosophy Inc for BioTech Research Labs948102256manufacture

Revised: 2/2010
Document Id: 50e7bd88-779b-424f-aa74-938a90603f7e
Set id: ea5676d8-e99e-4a4e-aae4-e59ddd20c706
Version: 1
Effective Time: 20100211
 
Philosophy, Inc.