S
Generic Name: octinoxate, octisalate, oxybenzone and titanium dioxide
Dosage Form: cream
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
Shelter Tinted
octinoxate, octisalate, oxybenzone, titanium dioxide cream
Product Information
Product Type
HUMAN OTC DRUG
NDC Product Code (Source)
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
Product Characteristics
Color
Score
Shape
Size
Flavor
Imprint Code
Contains
Packaging
#
NDC
Package Description
Multilevel Packaging
1
50184-4700-2
1 TUBE In 1 BOX
contains a TUBE (50184-4700-1)
1
50184-4700-1
56.7 g In 1 TUBE
This package is contained within the BOX (50184-4700-2)
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: 02/2010Philosophy, Inc.
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