Ultimate Miracle Worker SPF 30

Ultimate Miracle Worker SPF 30

Drug Labeling and Warnings

Drug Details

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ULTIMATE MIRACLE WORKER MULTI-REJUVENATING SPF 30- avobenzone, octinoxate, octocrylene cream 
Philosophy, Inc.

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.

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Ultimate Miracle Worker 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

  • 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
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)

Revised: 2/2019
 
Philosophy, Inc.


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