ULTIMATE MIRACLE WORKER MULTI-REJUVENATING SPF 30 (AVOBENZONE, OCTINOXATE, OCTOCRYLENE) CREAM [PHILOSOPHY, INC.]

ULTIMATE MIRACLE WORKER MULTI-REJUVENATING SPF 30 (AVOBENZONE, OCTINOXATE, OCTOCRYLENE) CREAM [PHILOSOPHY, INC.]
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NDC 50184-1013-1, 50184-1013-2, 50184-1013-3
Set ID 4387abab-ee1c-4e93-bea9-01624e8b4832
Category HUMAN OTC DRUG LABEL
Packager Philosophy, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    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

    • use in the morning as your daily moisturizer
    • 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, c12-15 alkyl benzoate, carthamus tinctorius (safflower) oleosomes, glycerin, cyclopentasiloxane, butylene glycol, methyl gluceth-20, gluconolactone, polyacrylamide, hydrogenated lecithin, cyclohexasiloxane, cetyl alcohol, bifida ferment lysate, phenoxyethanol, ammonium acryloyldimethyltaurate/vp copolymer, c13-14 isoparaffin, polysorbate 80, acrylates/c10-30 alkyl acrylate crosspolymer, sodium benzoate, sodium hydroxide, laureth-7, glycine soja (soybean) oil, fragrance, iris pallida root extract, ruby powder, disodium edta, gluconic acid, alcohol, mica, lecithin, adenosine, cellulose gum, retinol, peg-8, polysorbate 20, bht, titanium dioxide, chitosan, ethylhexylglycerin, glycolic acid, sorbitan oleate, calcium gluconate, tocopherol, behentrimoniumchloride, sodium bicarbonate, ascorbyl palmitate, beta-glucan, potassium phosphate, caprylyl glycol, 1,2-hexanediol, camellia sinensis leaf extract, coffea arabica (coffee) seed extract, pongamia pinnata seed extract, isopropyl alcohol, acetic acid, angelica archangelica root extract, benzoic acid, citrus aurantiumamara (bitter orange) peel extract, maltodextrin, citric acid, magnesium aluminum silicate, xanthan gum, lactic acid, ascorbic acid, sclerotium gum, bha, sorbic acid.

  • 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. AZ time (Monday – Friday)

  • Principal Display Panel - Ultimate Miracle Worker SPF 30 7 ml Carton Label

    ultimate
    miracle
    worker

    multi-rejuvenating
    cream
    broad spectrum
    spf 30 sunscreen

    philosophy:
    the best is yet
    to come.

    7 ml/0.25 fl. oz.

    Principal Display Panel - Ultimate Miracle Worker SPF 30 7 ml Carton Label
  • Principal Display Panel - Ultimate Miracle Worker SPF 30 15 ml Carton Label

    ultimate
    miracle
    worker

    philosophy: the best is yet to come.

    multi-rejuvenating cream
    broad spectrum spf 30 sunscreen

    philosophy

    15 ml/0.5 fl. oz.

    Principal Display Panel - Ultimate Miracle Worker SPF 30 15 ml Carton Label
  • Principal Display Panel - Ultimate Miracle Worker SPF 30 60 ml Carton Label

    ultimate
    miracle
    worker

    philosophy: the best is yet to come.

    multi-rejuvenating cream
    broad spectrum spf 30 sunscreen

    philosophy

    60 ml/2 fl. oz.

    Principal Display Panel - Ultimate Miracle Worker SPF 30 60 ml Carton Label
  • INGREDIENTS AND APPEARANCE
    ULTIMATE MIRACLE WORKER MULTI-REJUVENATING SPF 30 
    avobenzone, octinoxate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-1013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.7 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.99 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL GLYCOL (UNII: 1H07JK4G0C)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MILLETTIA PINNATA SEED (UNII: C2BRV53B1V)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    CITRUS AURANTIUM FRUIT RIND (UNII: 055456JHI7)  
    ANGELICA ARCHANGELICA ROOT (UNII: DTN01M69SN)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    LAURETH-7 (UNII: Z95S6G8201)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    IRIS PALLIDA ROOT (UNII: LVV57EM5OG)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLUCONIC ACID (UNII: R4R8J0Q44B)  
    ALCOHOL (UNII: 3K9958V90M)  
    MICA (UNII: V8A1AW0880)  
    ADENOSINE (UNII: K72T3FS567)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    RETINOL (UNII: G2SH0XKK91)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLIGLUSAM (UNII: 82LKS4QV2Y)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50184-1013-11 in 1 CARTON04/01/2018
    17 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:50184-1013-21 in 1 CARTON04/01/2018
    215 mL in 1 JAR; Type 0: Not a Combination Product
    3NDC:50184-1013-31 in 1 CARTON04/01/2018
    360 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2018
    Labeler - Philosophy, Inc. (948102256)
    Establishment
    NameAddressID/FEIBusiness Operations
    Process Technologies and Packaging Inc.809172885manufacture(50184-1013)

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