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Name:Bioelementsfacescreen
Manufacturer:Bioelements, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


FaceScreen

BIOELEMENTS FACESCREEN - homosalate, octinoxate, octisalate and oxybenzone cream 
Bioelements, Inc.

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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FaceScreen

Active Ingredients                        Purpose

Homosalate 10%                          Sunscreen

Octinoxate 7.5%                          Sunscreen

Octisalate 5%                              Sunscreen

Oxybenzone 6%                           Sunscreen

Warnings

-For external use only.

-Keep out of reach of children. If swallowed get medical help or contact poison control center right away.

-Stop use and ask a doctor if rash and irritation develops and lasts.

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

Uses

-for skin highly sensitive to sunburn


Directions
Apply liberally 30 minutes before sun exposure. Reapply as needed or after towel drying, swimming or perspiring. Children under 6 months of age, ask a doctor

Inactive Ingredients: Water (Aqua) (Eau), Aloe Barbadensis Leaf Juice, Glycerine, Cetyl Alcohol, Stearic Acid, C12-15 Alkyl Benzoate, Retinyl Palmitate, Tocopheryl Acetate, Panax Ginseng (Ginseng) Root Extract, Centella Asiatica (Gotu Kola) Extract, Angelica Polymorpha Sinensis (Dong Quai) Root Extract, Nasturtium Officinalis (Watercress) Extract, Rhus Glabra (Sumac) Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Dea-cetyl Phosphate, VP/Eicosene Copolymer, Phenoxyethanol, Butylene Glycol, Triethanolamine, Carbomer, Titanium Dioxide, Glycereth-2 Cocoate, Iodopropynyl Butylcarbamate

image of carton

Bioelements

SPF 50 Face Screen

For Maximum UVA/UVB Protection

Antioxidant Moisturizer

73 mL/ 2.5 Fl. Oz.

image of front label


BIOELEMENTS  FACESCREEN
homosalate, octinoxate, octisalate, oxybenzone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49825-115
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 10 mL  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 5 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 6 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF  
GLYCERIN  
STEARIC ACID  
ALKYL (C12-15) BENZOATE  
VITAMIN A PALMITATE  
DIMETHICONE  
DIETHANOLAMINE CETYL PHOSPHATE  
PHENOXYETHANOL  
BUTYLENE GLYCOL  
TROLAMINE  
TITANIUM DIOXIDE  
GLYCERETH-2 COCOATE  
PANAX GINSENG ROOT WATER  
CENTELLA ASIATICA  
ANGELICA SINENSIS ROOT  
RORIPPA NASTURTIUM-AQUATICUM  
CHAMOMILE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49825-115-02 1 BOTTLE ( BOTTLE) in 1 BOX contains a BOTTLE (49825-115-01)
1 NDC:49825-115-01 73 mL in 1 BOTTLE This package is contained within the BOX (49825-115-02)
2 NDC:49825-115-04 1 BOTTLE ( BOTTLE) in 1 BOX contains a BOTTLE (49825-115-03)
2 NDC:49825-115-03 73 mL in 1 BOTTLE This package is contained within the BOX (49825-115-04)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2009

Labeler - Bioelements, Inc. (174813923)
Registrant - Bioelements, Inc. (174813923)
Establishment
Name Address ID/FEI Operations
Chemolee Lab Corporation 809982754 manufacture

Revised: 03/2011 Bioelements, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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