RENEWED HOPE IN A JAR SPF 30- avobenzone, octinoxate, octocrylene cream

renewed hope in a jar spf 30 by

Drug Labeling and Warnings

renewed hope in a jar spf 30 by is a Otc medication manufactured, distributed, or labeled by Philosophy, Inc., Process Technologies and Packaging Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Renewed Hope in a Jar spf 30

Drug Facts

Active Ingredients

Avobenzone (2.7%), Octinoxate (6.99%), Octocrylene (2%).

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

• apply to clean face in the morning. we recommend use with renewed hope in a jar eye
• 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 value 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-sleeved shirts, pants, hats and sunglasses
  • children under 6 months: ask a doctor

Inactive Ingredients

water, carthamus tinctorius (safflower) oleosomes, butylene glycol, glycerin, c12-15 alkyl benzoate, methyl gluceth-20, glycolic acid, polyacrylamide, cyclopentasiloxane, ammonium acryloyldimethyltaurate/vp copolymer, hydrogenated lecithin, cyclohexasiloxane, phenoxyethanol, sodium hydroxide, c13-14 isoparaffin, cetyl alcohol, polysorbate 80, laureth-7, citric acid, fragrance, bismuth oxychloride, mandelic acid, tocopheryl acetate, disodium edta, synthetic fluorphlogopite, ethylhexyl palmitate, propanediol, gluconic acid, adenosine, sodium benzoate, bht, evodia rutaecarpa fruit extract, sodium bicarbonate, yeast extract, magnesium stearate, opuntia coccinellifera flower extract, silica dimethyl silylate, caprylyl glycol, ethylhexylglycerin, hyaluronic acid, silanetriol, sodium hyaluronate, sorbic acid, hexylene glycol.

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 time (Monday – Friday)

Principal Display Panel - Renewed Hope in a Jar Carton Label

renewed
hope
in a jar spf 30

refreshing & refining moisturizer
broad spectrum spf 30 sunscreen

philosophy: live with optimism.

renew with hope.

60 ml/2 fl. oz,

INGREDIENTS AND APPEARANCE

RENEWED HOPE IN A JAR SPF 30 
avobenzone, octinoxate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50184-1011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.99 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
GLYCOLIC ACID (UNII: 0WT12SX38S)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
LAURETH-7 (UNII: Z95S6G8201)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANDELIC ACID (UNII: NH496X0UJX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PROPANEDIOL (UNII: 5965N8W85T)
GLUCONIC ACID (UNII: R4R8J0Q44B)
ADENOSINE (UNII: K72T3FS567)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYALURONIC ACID (UNII: S270N0TRQY)
SILANETRIOL (UNII: E52D0J3TS5)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SORBIC ACID (UNII: X045WJ989B)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50184-1011-1	1 in 1 CARTON	04/01/2018
1		60 mL in 1 JAR; 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	04/01/2018

Labeler - Philosophy, Inc. (948102256)

Establishment
Name	Address	ID/FEI	Business Operations
Process Technologies and Packaging Inc.		809172885	manufacture(50184-1011)