![VANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]](https://medic.hrt.org//dailymed/images/98ebaa5c-ba28-4e70-a45c-6545eb756d8f/bottle.jpg)
![VANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]](https://medic.hrt.org//dailymed/images/98ebaa5c-ba28-4e70-a45c-6545eb756d8f/carton.jpg)
| NDC | 57627-124-01, 57627-124-02 |
| Set ID | 98ebaa5c-ba28-4e70-a45c-6545eb756d8f |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Merle Norman Cosmetics, Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
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ACTIVE INGREDIENT
Active Ingredients Purpose
Octinoxate 7.5% Sunscreen
Titanium Dioxide 7.1% SunscreenUses
· 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 damaged or broken skin
· When using this product keep out of eyes. Rinse with water to remove.Directions
· 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
· Children under 6 months: Ask a doctorInactive Ingredients
Water (Aqua), Cyclopenta siloxane, Clyclohexasiloxane, Isododecane, Alcohol Denat.,
Cetyl PEG/PPG-10/1 Dimethicone, C12-15 Alkyl Benzoate, Acrylates/Dimethicone Copolymer,
Silica, Acrylates Copolymer, Sodium Myristoyl Glutamate, Sorbitan Sesquioleate,
Polyhydroxystearic Acid, Disteardimonium Hectorite, Caprylyl Glycol, Aluminum Oxide,
Stearic Acid, Propylene Glycol, Propylene Carbonate, Tetrasodium EDTA, Methylisothiazolinone,
May Contain: Iron Oxides, Titanium Dioxide, Triethoxycaprylylsilane 022212. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN
octinoxate, titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.25 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.13 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) ISODODECANE (UNII: A8289P68Y2) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALUMINUM OXIDE (UNII: LMI26O6933) STEARIC ACID (UNII: 4ELV7Z65AP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLENE CARBONATE (UNII: 8D08K3S51E) EDETATE TRISODIUM (UNII: 420IP921MB) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-124-02 1 in 1 CARTON 08/22/2012 1 NDC:57627-124-01 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 08/22/2012 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(57627-124)
