Shelter Tinted

Generic Name: octinoxate, octisalate, oxybenzone and titanium dioxide
Dosage Form: cream

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 Type HUMAN OTC DRUG Item Code (Source) NDC:50184-4700
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
octinoxate (octinoxate) octinoxate 75 mg  in 1 g
OCTISALATE (OCTISALATE) OCTISALATE 50 mg  in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 50 mg  in 1 g
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description
1 NDC:50184-4700-2 1 TUBE (TUBE) in 1 BOX
1 NDC:50184-4700-1 56.7 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 09/14/2004
Labeler - Philosophy, Inc. (948102256)
Establishment
Name Address ID/FEI Operations
Philosophy Inc for BioTech Research Labs 948102256 manufacture
Revised: 02/2010
 
Philosophy, Inc.



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