Your browser does not support JavaScript! DERMA BLEMISH BALM (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [HUMEX,INC.]
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DERMA BLEMISH BALM (octinoxate, titanium dioxide, zinc oxide) cream
[Humex,Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not 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

package label

Drug Facts

Active ingredients                                                                                                  Purpose

Octinoxate 6.50%(wt) -------------------------------------------------- Sunscreen Agent

Titanium Dioxide 4.24%(wt) ------------------------------------------------------------------- Sunscreen Agent

Zinc Oxide 3.50%(wt) --------------------------------------------------------------------------- Sunscreen Agent

Warning

For external use only

When using this product

■ Avoid eye area. If contact occurs, rinse eyes thoroughly

■ Discontinue use if signs of irritation develops

Keep out of reach of the children

Other Information

■ store between 20-25 °C (68-77 °F)

■ avoid freezing and excessive heat above 40 °C (104 °F)

■ close cap after use.

Uses

■ Helps prevent sunburn

■ Provides high protection from sunburn

■ Helps brighten skin tone

■ Helps improve wrinkles

■ Covers blemishes without irritation

■ Helps improve skin condition

Direction

■ Evenly apply to the skin whole face at the final stage of skin care. Reapply it at anytime (before and after makeup) as needed.

Inactive Ingredient

■ Water ■ Cetyl Ethylhexanoate ■ Propylene Glycol ■ Cyclomethicone ■ Isononyl Isononanoate ■ Cetyl PEG/PPG-10/1 Dimethicone ■ Cyclopentasiloxane ■ Talc ■ Sorbitan Sesquioleate ■ Mineral Oil ■ Caprylic/Capric Triglyceride ■ Zinc Stearate ■ Microcrystalline Wax ■ Hexyl Laurate ■ Quaternium-18 Bentonite ■ Magnexium Sulfate ■ Dimethicone Copolyol ■ Dimethicone ■ Methyl Methacrylate Crosspolymer ■ Alumina ■ Silica ■ Butylene Glycol ■ Allantoin ■ Portulaca Oleracea Extract ■ chamomilla Recutita (Matricaria) Flower Extract ■ Aloe Barbadensis Leaf Extract ■ Sodium Hyaluronate ■ Adenosine ■ Triethoxycaprylylsilane ■ CI 77491 ■ CI 77492 ■ CI77499 ■ Phenoxyethanol ■ Arbutin

DERMA BLEMISH BALM  
octinoxate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76344-6001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE6.5 g  in 100 mL
Titanium Dioxide (TITANIUM DIOXIDE) Titanium Dioxide4.24 g  in 100 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide3.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Cetyl Ethylhexanoate 
Propylene Glycol 
Cyclomethicone 
Isononyl Isononanoate 
Talc 
Sorbitan Sesquioleate 
Mineral Oil 
Zinc Stearate 
Microcrystalline Wax 
Hexyl Laurate 
Dimethicone 
Allantoin 
Adenosine 
Triethoxycaprylylsilane 
Phenoxyethanol 
ARBUTIN 
Product Characteristics
Colorbrown (Yellowish brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76344-6001-21 in 1 BOX
1NDC:76344-6001-150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/22/2013
Labeler - Humex,Inc. (017945311)
Establishment
NameAddressID/FEIBusiness Operations
Hunusbio Inc557795012manufacture(76344-6001)

Revised: 6/2013
 
Humex,Inc.

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