Label: HOPE OIL FREE MOISTURIZER SPF 30- octinoxate and octisalate and oxybenzone and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 50184-6100-1, 50184-6100-2 - 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 April 5, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS:
WATER
C12-15 ALKYL BENZOATE
DIBUTYL ADIPATE
NEOPENTYL GLYCOL DIHEPTANOATE
GLYCERIN
POTASSIUM CETYL PHOSPHATE
BEHENYL ALCOHOL
BUTYLOCTYL SALICYLATE
ALUMINUM STARCH OCTENYLSUCCINATE
ARACHIDYL ALCOHOL
HYDROGENATED PALM GLYCERIDES
DIMETHICONE
BEHENOXY DIMETHICONE
SODIUM STEAROYL GLUTAMATE
HYDROGENATED LECITHIN
RUBUS FRUTICOSUS (BLACKBERRY) LEAF EXTRACT
ARGININE
DIPOTASSIUM GLYCYRRHIZINATE
POLYHYDROXYSTEARIC ACID
BETA-GLUCAN
TOCOPHERYL ACETATE
CAMELLIA SINENSIS LEAF POWDER
ARACHIDYL GLUCOSIDE
MALTODEXTRIN
BEHENYL ALCOHOL
XANTHAN GUM
DISODIUM EDTA
CITRIC ACID
TRIETHOXYCAPRYLYLSILANE
ETHYLHEXYLGLYCERIN
PHENOXYETHANOL
CHLORPHENESIN
- ASK DOCTOR
- USER SAFETY WARNINGS
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HOPE OIL FREE MOISTURIZER SPF 30
octinoxate and octisalate and oxybenzone and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50184-6100 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 40 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Cation - UNII:13S1S8SF37) Zinc Oxide 45 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) DOCOSANOL (UNII: 9G1OE216XY) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) DIMETHICONE (UNII: 92RU3N3Y1O) MONOSODIUM GLUTAMATE ANHYDROUS (UNII: C3C196L9FG) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) RUBUS FRUTICOSUS LEAF (UNII: YQ2S06L8S9) ARGININE (UNII: 94ZLA3W45F) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MALTODEXTRIN (UNII: 7CVR7L4A2D) BENZYL ALCOHOL (UNII: LKG8494WBH) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) OCTYLTRIETHOXYSILANE (UNII: LDC331P08E) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50184-6100-2 1 in 1 BOX 1 NDC:50184-6100-1 56 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/01/2010 Labeler - Philosophy, Inc. (948102256) Establishment Name Address ID/FEI Business Operations Philosophy Inc for BioTech Research Labs 948102256 manufacture
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