Your browser does not support JavaScript! MALLY PERFECT PREP PORELESS PRIMER (AVOBENZONE, OCTINOXATE) CREAM [MALLYGIRL, LLC]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

Out of scope

MALLY PERFECT PREP PORELESS PRIMER (avobenzone, octinoxate) cream
[MallyGirl, LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

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.

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

  • 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.

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76119-1170
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE0.6 g  in 30.0 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE2.25 g  in 30.0 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 
DIMETHICONE 
CYCLOMETHICONE 
CORN OIL 
ALKYL (C12-15) BENZOATE 
POLYETHYLENE GLYCOL 900 
POLYMETHYLSILSESQUIOXANE (11 MICRONS) 
ALPHA-TOCOPHEROL ACETATE 
GLYCYRRHIZA GLABRA 
PEG-10 RAPESEED STEROL 
CERAMIDE 2 
TRIBEHENIN 
PALMITOYL OLIGOPEPTIDE 
SILICA DIMETHYL SILYLATE 
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) 
PROPYLENE CARBONATE 
PHENOXYETHANOL 
MICA 
TITANIUM DIOXIDE 
D&C RED NO. 17 
BISMUTH OXYCHLORIDE 
SILICON DIOXIDE 
PENTAERYTHRITYL TETRAISOSTEARATE 
ETHYLHEXYL PALMITATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76119-1170-11 in 1 BOX
130 mL in 1 TUBE
2NDC:76119-1170-21 in 1 BOX
228.3 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/29/2012
Labeler - MallyGirl, LLC (167262554)

Revised: 7/2013
 
MallyGirl, LLC

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services