Label: TIMELESS ILLUMINATING MAKEUP SPF 30 ALABASTER MERLE NORMAN- octinoxate, oxybenzone cream
- NDC Code(s): 57627-177-01, 57627-177-02
- Packager: Merle Norman Cosmetics, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 25, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ASK DOCTOR
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
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
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INGREDIENTS AND APPEARANCE
TIMELESS ILLUMINATING MAKEUP SPF 30 ALABASTER MERLE NORMAN
octinoxate, oxybenzone creamProduct 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)
