Timeless Illuminating Makeup Broad Spectrum SPF 30

Timeless Illuminating Makeup SPF 30 Rich Walnut by

Drug Labeling and Warnings

Timeless Illuminating Makeup SPF 30 Rich Walnut by is a Otc medication manufactured, distributed, or labeled by Merle Norman Cosmetics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TIMELESS ILLUMINATING MAKEUP SPF 30 RICH WALNUT MERLE NORMAN- octinoxate, oxybenzone cream 
Merle Norman Cosmetics, 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.

----------

Timeless Illuminating Makeup Broad Spectrum SPF 30

​Active Ingredients                   Purpose

Octinoxate 7.5%                          Sunscreen

Oxybenzone 2.0%                       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 

​Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

​Stop use and ask a doctor ​if rash occurs

​Warnings

For external use only

  • Do not use on domaged or broken skin
  • ​When using this product ​keep out of eyes. Rinse with water to remove.

Directions

  • For sunscreen use:
  • apply liberally and evenly 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulary use a sunscreeen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit tim in the sun, especially from 10a.m. - 2p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Water/Aqua/Eau, Cyclopentasiloxane, Tiatnium Dioxide (CI 77891). Caprylic/Capric Triglyceride, Phenyl Trimethicone, Methyl Trimethicone, Aluminum Oxide, Lauryl PEG-10 Tris(Trimethylsiloxysiloxy)silyethyl Dimethicone, Trimethylsiloxysilicate, Dimethicone, Butylene Glycol, Glycerin, Gold, Palmitoyl Hexapeptide-14, Peat Extract, Diglucosyl Gallic Acid, Hydroxyethylcellulose, Saccharomyces/Xylinum/Black Tea Ferment, HDI/Trimethylol Hexyllactone Crosspolymer, Polymethylsilsesquioxane, Triethoxycaprylylsilane, Bis-Stearyl Dimethicone, PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dextrin Palimitate, Caprylyl Methicone, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-3Beeswax, Silica, Mica (CI 77019), Ethoxydiglycol, Magnesium Sulfate, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Phenoxyethanol, Tetrasodium EDTA, Potassium Sorabate, Talc, ​May Contain

Barium Sulfate (CI 77120), Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77489, CI 77491, CI 77492, CI 77499), Ultramarines (CI 77007)

Timeless Illuminating Makeup

Broad Spectrum SPF 30

Merle Norman

30 mL e 1 FL. OZ.

Box

Bottle

TIMELESS ILLUMINATING MAKEUP SPF 30 RICH WALNUT  MERLE NORMAN
octinoxate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 57627-184
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
GOLD (UNII: 79Y1949PYO)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE SODIUM (UNII: MP1J8420LU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
TALC (UNII: 7SEV7J4R1U)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERROUS OXIDE (UNII: G7036X8B5H)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 57627-184-021 in 1 CARTON01/24/201701/01/2020
1NDC: 57627-184-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/24/201701/01/2020
Labeler - Merle Norman Cosmetics, Inc (008479388)
Registrant - Merle Norman Cosmetics, Inc (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman Cosmetics, Inc008479388manufacture(57627-184)

Revised: 3/2020