Shelter

Dosage form: cream
Ingredients: Octinoxate 75mg in 1g, Octisalate 50mg in 1g, Oxybenzone 50mg in 1g, Titanium Dioxide 12mg in 1g
Labeler: Philosophy, Inc.
NDC Code: 50184-4800

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.

Active Ingredients

Octinoxate......7.5%

Octisalate.......5.0%

Oxybenzone...... 5.0%

Titanium Dioxide......1.2%


Inactive Ingredients

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

KEEP OUT OF REACH OF CHILDREN

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

WHEN USING

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

INDICATIONS

HELPS PREVENT SUNBURN. HIGHER SPF GIVES MORE SUNBURN PROTECTION

SHELTER  
octinoxate and octisalate and oxybenzone and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-4800
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 Dioxide12 mg  in 1 g
Packaging
#Item CodePackage Description
1NDC:50184-4800-21 TUBE (TUBE) in 1 BOX
1NDC:50184-4800-156.7 g in 1 TUBE
2NDC:50184-4800-41 TUBE (TUBE) in 1 BOX
2NDC:50184-4800-3113.4 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)

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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