TIMELESS ILLUMINATING MAKEUP SPF 30 ALABASTER MERLE NORMAN- octinoxate, oxybenzone cream

Timeless Illuminating Makeup SPF 30 Alabaster by

Drug Labeling and Warnings

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

Drug Details [pdf]

ASK DOCTOR

​Active Ingredients                   Purpose

Octinoxate 7.5%                          Sunscreen

Oxybenzone 2.0%                       Sunscreen

PURPOSE

​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

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

INDICATIONS & USAGE

​Stop use and ask a doctor ​if rash occurs

WARNINGS

​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.

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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)

PRINCIPAL DISPLAY PANEL

Timeless Illuminating Makeup

Broad Spectrum SPF 30

Merle Norman

30 mL e 1 FL. OZ.

INGREDIENTS AND APPEARANCE

TIMELESS ILLUMINATING MAKEUP SPF 30 ALABASTER  MERLE NORMAN
octinoxate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-177
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-177-02	1 in 1 CARTON	01/24/2017
1	NDC: 57627-177-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product

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	Business Operations
Merle Norman Cosmetics, Inc		008479388	manufacture(57627-177)