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Shelter

Philosophy, Inc.

Active Ingredients


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

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



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

Shelter

Octinoxate and Octisalate and Oxybenzone and Titanium Dioxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50184-4800
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 75 mg
OCTISALATE OCTISALATE 50 mg
OXYBENZONE OXYBENZONE 50 mg
titanium dioxide 12 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50184-4800-1 56.7 in 1 TUBE
2 NDC:50184-4800-3 113.4 in 1 TUBE
3 NDC:50184-4800-4 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2004-09-14


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