MALLY PERFECT PREP PORELESS PRIMER  - avobenzone and octinoxate cream 
MallyGirl, LLC

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.

----------

mally Perfect Prep Poreless Primer Broad Spectrum SPF 15

DRUG FACTS


Active Ingredients

Avobenzone 2.0%

Ocitnaxate 7.5%

Purpose

Sunscreen

Sunscreen

Use

For external use only

Do not use on damaged or broken skin.

Stop use and ask doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

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

Directions

Inactive Ingredients

Cyclopentasiloxane, Dimethicone/Vinyl Dimeticone Crosspolymer, Cyclomethicone, Hydrogenated Vegetable Oil, C12-15 Alkyl Benzoate, Peg/Ppg-18/18 Dimethicone, Polymethylsilsesquioxane, Tocopheryl Acetate, Glycyrrhiza Glabra (Licorice) Root Extract, Silica, PEG-10 Rapeseed Sterol, Ceramide 2, Atelocollagen, Tribehenin, Palmitoyl Oligopeptide, Silica Dimethyl Silylate, Sodium Chondroitin Sulfate, Pentaerythrityl Tetraisostearate, Ethylthexyl Palmitate, Disteardimonium Hectorite, Propylene Carbonate, Phenoxyethanol, Mica, Titanium Dioxide (CI 77891), Red 17 (CI 26100), Bismuth Oxychloride (CI 77163). Product made in the USA

Other Information

Prices and availability are subject to change without notice.

Prices shown do not include shipping, handling, and applicable sales tax.

QVC and QVC.com are registered trademarks of ER Marks, Inc.

Distributed by Mallygirl LLC - P.O. Box 42727 - Baltimore, MD 21284-2727

Principal Display Panel

mally

Perfect Prep

Poreless Primer

with sunscreen

Broad Spectrum

SPF15

Tube Label
Jar Label

Drug Facts Label Carton
MALLY PERFECT PREP PORELESS PRIMER  
avobenzone, octinoxate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76119-1170
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.6 g  in 30.0 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.25 g  in 30.0 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CORN OIL (UNII: 8470G57WFM)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
POLYETHYLENE GLYCOL 900 (UNII: UEP843BRCQ)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
CERAMIDE 2 (UNII: C04977SRJ5)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 17 (UNII: ND733RX3JN)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76119-1170-1 1 in 1 BOX
1 30 mL in 1 TUBE
2 NDC:76119-1170-2 1 in 1 BOX
2 28.3 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 03/29/2012
Labeler - MallyGirl, LLC (167262554)

Revised: 7/2013
Document Id: 543156d2-2004-4809-9fda-72fa8979d1e4
Set id: f8e69c79-01b6-456a-b26d-0869e8b88080
Version: 3
Effective Time: 20130715
 
MallyGirl, LLC