Label: ULTIMATE MIRACLE WORKER EYE SPF 15- avobenzone, homosalate, octinoxate, octocrylene cream
- NDC Code(s): 50184-1012-1
- 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
-
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
- use in the morning. apply gently under eyes, extending toward the temple
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water-resistant sunscreen if swimming or sweating
- Directions
-
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, glycerin, dicaprylyl carbonate, isononyl isononanoate, methyl methacrylate crosspolymer, dimethicone, cyclopentasiloxane, tribehenin peg-20 esters, cetyl alcohol, isostearyl isostearate, trisiloxane, glyceryl stearate, peg-100 stearate, cetyl stearate, stearic acid, bifida ferment lysate, potassium cetyl phosphate, phenoxyethanol, dimethicone crosspolymer, caffeine, chlorphenesin, propylene glycol, carbomer, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, glycine soja (soybean) oil, sodium hydroxide, squalane, hippophae rhamnoides oil, iris pallida root extract, ruby powder, disodium edta, alcohol, algae extract, mica, lecithin, ascorbyl glucoside, adenosine, cellulose gum, ginkgo biloba leaf extract, retinol, peg-8, polysorbate 20, polysorbate 60, calcium sodium phos-phosilicate, bht, acrylates/c10-30 alkyl acrylate crosspolymer, chitosan, ethylhexylglycerin, glycolic acid, sorbitan oleate, tocopherol, aesculus hippocastanum (horse chestnut) seed extract, glucose, lactic acid, behentrimonium chloride, glycyrrhiza uralensis (licorice) root extract, sodium benzoate, ascorbyl palmitate, potassium phosphate, potassium sorbate, camellia sinensis leaf extract, coffea arabica (coffee) seed extract, pongamia pinnata seed extract, isopropyl alcohol, acetic acid, angelica archangelica root extract, citrus aurantium amara (bitter orange) peel extract, maltodextrin, citric acid, magnesium aluminum silicate, xanthan gum, ascorbic acid, glycyrrhiza glabra (licorice) rhizome/root extract, glycyrrhiza glabra (licorice) root extract, caprylyl glycol, sclerotium gum, bha, sorbic acid, titanium dioxide (ci 77891).
- Other Information
- Questions or Comments?
- Principal Display Panel - Ultimate Miracle Worker Eye Carton Label
-
INGREDIENTS AND APPEARANCE
ULTIMATE MIRACLE WORKER EYE SPF 15
avobenzone, homosalate, octinoxate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50184-1012 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 HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 2 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.16 g in 100 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL GLYCOL (UNII: 00YIU5438U) BETASIZOFIRAN (UNII: 2X51AD1X3T) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) SORBIC ACID (UNII: X045WJ989B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9) CETYL ALCOHOL (UNII: 936JST6JCN) ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y) TRISILOXANE (UNII: 9G1ZW13R0G) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) CETYL STEARATE (UNII: 06RI5UQA7L) STEARIC ACID (UNII: 4ELV7Z65AP) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) CAFFEINE (UNII: 3G6A5W338E) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) SOYBEAN OIL (UNII: 241ATL177A) SODIUM HYDROXIDE (UNII: 55X04QC32I) SQUALANE (UNII: GW89575KF9) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ALCOHOL (UNII: 3K9958V90M) MICA (UNII: V8A1AW0880) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) ADENOSINE (UNII: K72T3FS567) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) GINKGO (UNII: 19FUJ2C58T) RETINOL (UNII: G2SH0XKK91) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYSORBATE 20 (UNII: 7T1F30V5YH) POLYSORBATE 60 (UNII: CAL22UVI4M) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) POLIGLUSAM (UNII: 82LKS4QV2Y) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCOLIC ACID (UNII: 0WT12SX38S) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TOCOPHEROL (UNII: R0ZB2556P8) HORSE CHESTNUT (UNII: 3C18L6RJAZ) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T) GLYCYRRHIZA URALENSIS (UNII: 42B5YD8F0K) SODIUM BENZOATE (UNII: OJ245FE5EU) ASCORBYL PALMITATE (UNII: QN83US2B0N) POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ARABICA COFFEE BEAN (UNII: 3SW678MX72) MILLETTIA PINNATA SEED (UNII: C2BRV53B1V) ISOPROPYL ALCOHOL (UNII: ND2M416302) ACETIC ACID (UNII: Q40Q9N063P) CITRUS AURANTIUM FRUIT RIND (UNII: 055456JHI7) MALTODEXTRIN (UNII: 7CVR7L4A2D) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) XANTHAN GUM (UNII: TTV12P4NEE) ASCORBIC ACID (UNII: PQ6CK8PD0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50184-1012-1 1 in 1 CARTON 04/01/2018 1 15 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(50184-1012)
