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Name:Bioelements, Inc. Spf 50 Facescreen
Manufacturer:Bioelements, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


SPF 50 FaceScreen

BIOELEMENTS, INC.  SPF 50 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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SPF 50 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.

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 (Gatu Kola) Extract, Angelica Polymorpha Sinensis (Dong Quai) Root Extract, Nasturtium Officinale (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

for Maximum UVA/UVB Protection

Antioxidant Moisturizer

73 mL/2.5 Fl. Oz.

image of primary label


BIOELEMENTS, INC.   SPF 50 FACESCREEN
homosalate, octinoxate, octisalate, oxybenzone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49825-117
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
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49825-117-02 1 JAR ( JAR) in 1 BOX contains a JAR (49825-117-01)
1 NDC:49825-117-01 73 mL in 1 JAR This package is contained within the BOX (49825-117-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2010

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

Revised: 08/2010 Bioelements, Inc.



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


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