HOPE IN A JAR A TO Z CREAM BROAD SPECTRUM SPF 20 SUNSCREEN- titanium dioxide, zinc oxide cream

hope in a jar by

Drug Labeling and Warnings

hope in a jar by is a Otc medication manufactured, distributed, or labeled by Philosophy, Mana Products, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Titanium Dioxide (5.0%)

Zinc Oxide (5.0%)

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

For external use only.

Do not use on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• pump to dispense product, layer for more coverage
• 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 – this product should NOT be used on children of any age

Inactive Ingredients

aqua/water/eau, cyclopentasiloxane, octyldodecyl neopentanoate, butylene glycol, glycerin, peg/ppg-18/18 dimethicone, dimethicone, camellia oleifera leaf extract, aluminum hydroxide, stearic acid, boron nitride, lactic acid, sodium chloride, caprylyl glycol, sodium dehydroacetate, mica, phytantriol, triethoxycaprylylsilane, dextrin palmitate, sodium hyaluronate, lysine, retinyl acetate, tetrahexyldecyl ascorbate, tocopherol, avena sativa (oat) bran extract, magnesium ascorbyl phosphate, magnesium chloride, potassium chloride, retinyl palmitate, potassium sorbate, hexylene glycol, disodium edta, palmitic acid, sodium benzoate, zinc chloride, phenoxyethanol, may contain: titanium dioxide (ci 77891), zinc oxide (ci 77947), iron oxides (ci 77491, ci 77492, ci 77499).

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)

Principal Display Panel – 30mL Box Label

philosophy

hope
in a jar

a to z cream

broad spectrum

spf 20 sunscreen

complexion perfecting

bb cream

30ml/1 fl. oz.

INGREDIENTS AND APPEARANCE

HOPE IN A JAR   A TO Z CREAM BROAD SPECTRUM SPF 20 SUNSCREEN
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50184-1033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.35 g  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	5.49 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
BORON NITRIDE (UNII: 2U4T60A6YD)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
MICA (UNII: V8A1AW0880)
PHYTANTRIOL (UNII: 8LVI07A72W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LYSINE (UNII: K3Z4F929H6)
VITAMIN A ACETATE (UNII: 3LE3D9D6OY)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TOCOPHEROL (UNII: R0ZB2556P8)
OAT BRAN (UNII: KQX236OK4U)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PALMITIC ACID (UNII: 2V16EO95H1)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ZINC CHLORIDE (UNII: 86Q357L16B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50184-1033-2	1 in 1 BOX	05/01/2013
1	NDC: 50184-1033-1	30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2013

Labeler - Philosophy (948102256)

Establishment
Name	Address	ID/FEI	Business Operations
Mana Products, INC		032870270	manufacture(50184-1033)