OTC Medication Information: Timeless Illuminating Makeup SPF 30 Sandy Beige Merle Norman

TIMELESS ILLUMINATING MAKEUP SPF 30 SANDY BEIGE MERLE NORMAN- octinoxate and 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.

​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
(click image for full-size original)
Bottle
(click image for full-size original)
TIMELESS ILLUMINATING MAKEUP SPF 30 SANDY BEIGE MERLE NORMAN
octinoxate, oxybenzone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-182
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE 5
TITANIUM DIOXIDE
MEDIUM-CHAIN TRIGLYCERIDES
PHENYL TRIMETHICONE
METHYL TRIMETHICONE
ALUMINUM OXIDE
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
DIMETHICONE
BUTYLENE GLYCOL
GLYCERIN
GOLD
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
TRIETHOXYCAPRYLYLSILANE
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
DEXTRIN PALMITATE (CORN; 20000 MW)
CAPRYLYL TRISILOXANE
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)
SILICON DIOXIDE
MICA
DIETHYLENE GLYCOL MONOETHYL ETHER
MAGNESIUM SULFATE, UNSPECIFIED FORM
CAPRYLYL GLYCOL
ETHYLHEXYLGLYCERIN
HEXYLENE GLYCOL
PHENOXYETHANOL
EDETATE SODIUM
POTASSIUM SORBATE
TALC
BARIUM SULFATE
BISMUTH OXYCHLORIDE
FERROUS OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
ULTRAMARINE BLUE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57627-182-02 1 BOTTLE in 1 CARTON contains a BOTTLE (57627-182-01)
1 NDC:57627-182-01 30 mL in 1 BOTTLE This package is contained within the CARTON (57627-182-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/24/2017
Labeler — Merle Norman Cosmetics, Inc (008479388)
Registrant — Merle Norman Cosmetics, Inc (008479388)
Establishment
Name Address ID/FEI Operations
Merle Norman Cosmetics, Inc 008479388 manufacture (57627-182)

Revised: 10/2019 Merle Norman Cosmetics, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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