IQ DERMA REGIMEN HYDRATING UV SHIELD SPF 25- octinoxate, oxybenzone, zinc oxide and ensulizole cream 
DermStore, LLC (Formerly Intelligent Beauty, 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.

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Drug Facts

Active Ingredients:     Ensulizole 2%   Octinoxate 7.5%     Oxybenzone 4%  Zinc Oxide 3%                                         

Purpose: Sunscreen

USES:
  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection

Warnings

For external use only

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

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Stop use and ask a doctor if rash or irritation develops and lasts

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

Directions:

  • Apply evenly onto face 30 minutes before sun exposure and as needed prior to makeup application.
  • children under 6 months of age: ask a doctor


Inactive Ingredients:Water, Octyldodecyl Neopentanoate, Glycerin, Butylene Glycol, Carbomer, Polysorbate 20, Palmitoyll Oligopeptide, Palmitoyl Tetrapeptide-7, Diethylhexyl Carbonate, Caprylic/Capric/Myristic/Stearic Triglyceride, Cetearyl Alcohol, Ceteareth-20, Cyclopentasiloxane, Cyclohexasiloxane,Dicetyl Phosphate, Ceteth-10 Phosphate, Polymethyl Methacrylate, Tocopheryl Acetate, Dimethicone, Xanthan Gum, Magnesium Aluminum Silicate, Tetrasodium EDTA, PVP/Eicosene Copolymer, Potassium Hydroxide, Triethoxycaprylylsilane, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol.



Regimen ctn


IQ DERMA REGIMEN HYDRATING UV SHIELD  SPF 25
ensulizole, octinoxate, oxybenzone, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:24559-228
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE4.0 g  in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE3.0 g  in 100 g
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
POLYSORBATE 20 
CETOSTEARYL ALCOHOL 
CYCLOMETHICONE 
1,3-BUTYLENE GLYCOL 
MAGNESIUM ALUMINUM SILICATE 
POTASSIUM HYDROXIDE 
PHENOXYETHANOL 
HEXYLENE GLYCOL 
ALPHA-TOCOPHEROL ACETATE 
DIMETHICONE 
EDETATE SODIUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24559-228-021 in 1 CARTON
1NDC:24559-228-0150 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2006
Labeler - DermStore, LLC (Formerly Intelligent Beauty, LLC) (015792160)

Revised: 12/2013
 
DermStore, LLC (Formerly Intelligent Beauty, LLC)