ULTIMATE MIRACLE WORKER EYE SPF 15- avobenzone, homosalate, octinoxate, octocrylene cream

ultimate miracle worker eye spf 15 by

Drug Labeling and Warnings

ultimate miracle worker eye spf 15 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

Drug Facts

Active Ingredients

Avobenzone 2.7%

Homosalate 2%

Octinoxate 5%

Octocrylene 2.16%

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

• 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

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

• protect this product from excessive heat and direct sun

Questions or Comments?

Call toll-free 1-800-568-3151 from 9 a.m. - 8 p.m. EST (Monday – Friday)

Principal Display Panel - Ultimate Miracle Worker Eye Carton Label

ultimate
miracle
worker eye

philosophy: the best is yet to come.

multi-rejuvenating eye cream
broad spectrum spf 15 sunscreen

wrinkles, firmness, dark circles, puffiness

philosophy

15 ml/0.5 fl. oz.

INGREDIENTS AND APPEARANCE

ULTIMATE MIRACLE WORKER EYE SPF 15 
avobenzone, homosalate, octinoxate, octocrylene cream

Product 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
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)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
SORBIC ACID (UNII: X045WJ989B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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)