Shelter Tinted

Dosage form: cream
Ingredients: octinoxate 75mg in 1g, OCTISALATE 50mg in 1g, OXYBENZONE 50mg in 1g, TITANIUM DIOXIDE 10mg in 1g
Labeler: Philosophy, Inc.
NDC Code: 50184-4700

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.

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

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SHELTER TINTED 
octinoxate, octisalate, oxybenzone, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-4700
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
octinoxate (octinoxate) octinoxate75 mg  in 1 g
OCTISALATE (OCTISALATE) OCTISALATE50 mg  in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE50 mg  in 1 g
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:50184-4700-21 TUBE (TUBE) 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/FEIOperations
Philosophy Inc for BioTech Research Labs948102256manufacture

Revised: 02/2010
 
Philosophy, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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