Label: SHELTER TINTED- octinoxate, octisalate, oxybenzone, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 50184-4700-1, 50184-4700-2 - Packager: Philosophy, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated February 11, 2010
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INACTIVE INGREDIENT
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
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SHELTER TINTED
octinoxate, octisalate, oxybenzone, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50184-4700 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate 75 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) STEARETH-21 (UNII: 53J3F32P58) DIMETHICONE (UNII: 92RU3N3Y1O) METHYL METHACRYLATE (UNII: 196OC77688) DOCOSANOL (UNII: 9G1OE216XY) STEARETH-2 (UNII: V56DFE46J5) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) SQUALENE (UNII: 7QWM220FJH) RICE BRAN (UNII: R60QEP13IC) RUBUS FRUTICOSUS LEAF (UNII: YQ2S06L8S9) ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8) ALOE VERA LEAF (UNII: ZY81Z83H0X) MALTODEXTRIN (UNII: 7CVR7L4A2D) CARBOMER 934 (UNII: Z135WT9208) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALUMINUM OXIDE (UNII: LMI26O6933) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) EDETATE DISODIUM (UNII: 7FLD91C86K) CHLORPHENESIN (UNII: I670DAL4SZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) OCTYLTRIETHOXYSILANE (UNII: LDC331P08E) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50184-4700-2 1 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 Business Operations Philosophy Inc for BioTech Research Labs 948102256 manufacture
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