HOPE OIL FREE MOISTURIZER SPF 30- octinoxate and octisalate and oxybenzone and zinc oxide cream

Hope Oil Free Moisturizer SPF 30 by

Drug Labeling and Warnings

Hope Oil Free Moisturizer SPF 30 by is a Otc medication manufactured, distributed, or labeled by Philosophy, Inc., Philosophy Inc for BioTech Research Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

OCTINOXATE (7.5%)

OCTISALATE (5.0%)

OXYBENZONE (4.0%)

ZINC OXIDE (4.5%)

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

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

USER SAFETY WARNINGS

WARNINGS: FOR EXTERNAL USE ONLY

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.  CHILDREN UNDER 6 MONTHS OF AGE - ASK A DOCTOR.

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CENTER RIGHT AWAY.

PURPOSE

HELPS PREVENT SUNBURN

HIGHER SPF GIVES MORE SUNBURN PROTECTION.

INDICATIONS & USAGE

DIRECTIONS:

APPLY LIBERALLY TO CLEAN, DRY FACE IN THE MORNING BEFORE SUN EXPOSURE AND AS NEEDED.  CHILDREN UNDER 6 MONTHS OF AGE ASK DOCTOR.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

HOPE OIL FREE MOISTURIZER SPF 30 
octinoxate and octisalate and oxybenzone and zinc oxide cream

Product 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