HOPE IN A JAR FOR DRY SKIN SPF BROAD SPECTRUM SPF 20 SUNSCREEN AND EXTRA-RICH MOISTURIZER FOR NORMAL TO DRY SKIN- avobenzone, octinoxate, and oxybenzone cream

Hope In A Jar For Dry Skin SPF by

Drug Labeling and Warnings

Hope In A Jar For Dry Skin SPF 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

Avobenzone (2.0%)......Sunscreen

Octinoxate (7.0%)........Sunscreen

Ozybenzone (2.5%)......Sunscreen

PURPOSE

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep our of eyes.

Rinse with water to remove.

Stop use and ask a doctor if a rash occurs.

DOSAGE & ADMINISTRATION

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures, including:
• limit time in the sun, especially from 10 a.m.-2 p.m.
• wear long-sleeve shirts, pants, hats and sunglasses
• children under 6 months: ask a doctor

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.

OTHER SAFETY INFORMATION

Other Information

• protect this product from excessive heat and direct sun

Questions or Comments?

Call toll-free 1-800-568-3151 from 6 a.m.-5 p.m. MST (Monday-Friday)

INACTIVE INGREDIENT

Inactive Ingredients

Water (aqua), butyloctyl salicylate, behenoxy dimethicone, glycerin, behinic acid, c12-c14 alkyl benzoate, glyceryl distearate, blyceryl stearate se, behenyl alcohol, benzyl alcohol, cyclopentasiloxane, cyclohexasiloxane, stearic acid, lavandula angustifolia (lavender) oil, butylene glycol, carbomer, polysorbate 20, palmitoyl pentapeptide-4, beta-glucan, arginine, sodium stearoyl lactylate, triethanolamine, acrylate/c10-30 alkyl acrylate crosspolymer, potassium ascorbyl tocopheryl  phosphate, haematococcus pluvialis extract, carthamus tinctorius (safflower) seed oil, helianthus annus (sunflower) seed oil, tocopherol, tocotrienols, trilein, trilinolein, sodium lactate, potassium stearate, bht, mthyldibromo glutaronitrile, phenoxyethanol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HOPE IN A JAR FOR DRY SKIN SPF   BROAD SPECTRUM SPF 20 SUNSCREEN AND EXTRA-RICH MOISTURIZER FOR NORMAL TO DRY SKIN
avobenzone, octinoxate, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50184-6400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	1.392 g  in 60 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	4.242 g  in 60 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	1.98 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DOCOSANOIC ACID (UNII: H390488X0A)
GLYCERIN (UNII: PDC6A3C0OX)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
DOCOSANOL (UNII: 9G1OE216XY)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)
1,3-BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOMER 934 (UNII: Z135WT9208)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ARGININE (UNII: 94ZLA3W45F)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
SAFFLOWER OIL (UNII: 65UEH262IS)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
SQUALENE (UNII: 7QWM220FJH)
RICE BRAN (UNII: R60QEP13IC)
METHYLDIBROMO GLUTARONITRILE (UNII: YX089CPS05)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50184-6400-2	1 in 1 BOX
1	NDC: 50184-6400-1	60 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/22/2010

Labeler - Philosophy, Inc. (948102256)

Establishment
Name	Address	ID/FEI	Business Operations
Philosophy Inc for BioTech Research Labs		948102256	manufacture(50184-6400)