MALLY PERFECT PREP PORELESS PRIMER- avobenzone, octinoxate cream

mally Perfect Prep Poreless Primer by

Drug Labeling and Warnings

mally Perfect Prep Poreless Primer by is a Otc medication manufactured, distributed, or labeled by MallyGirl, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Avobenzone 2.0%

Ocitnaxate 7.5%

Purpose

Sunscreen

Sunscreen

Use

• 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.
  

WARNINGS

For external use only

DO NOT USE

Do not use on damaged or broken skin.

STOP USE

Stop use and ask doctor if rash occurs.

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Children under 6 months: ask a doctor
• Sun Protection Measures. Spending time in the sun increases risk of skin cancer and early aging. To decrease this risk regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higer and other sun protection measures including
• Limit time in the sun especially from 10:00 a.m. - 2:00 p.m.
• Wear long sleeved shirts, pants, hats and sunglasses
  

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

• Protect this product from excessive heat and direct sun.
  

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

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)