Label: RENEWED HOPE IN A JAR SPF 30- avobenzone, octinoxate, octocrylene cream
- NDC Code(s): 50184-1011-1
- 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 January 28, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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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
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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
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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
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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
- Questions or Comments?
- Principal Display Panel - Renewed Hope in a Jar Carton Label
-
INGREDIENTS AND APPEARANCE
RENEWED HOPE IN A JAR SPF 30
avobenzone, octinoxate, octocrylene creamProduct 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)
