Bioelements, Inc. SPF 50 FaceScreen

Dosage form: cream
Ingredients: HOMOSALATE 10mL in 100mL, OCTINOXATE 7.5mL in 100mL, OCTISALATE 5mL in 100mL, OXYBENZONE 6mL in 100mL
Labeler: Bioelements, Inc.
NDC Code: 49825-117

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.

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

Bioelements

SPF 50

for Maximum UVA/UVB Protection

Antioxidant Moisturizer

73 mL/2.5 Fl. Oz.

BIOELEMENTS, INC.   SPF 50 FACESCREEN
homosalate, octinoxate, octisalate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-117
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE10 mL  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALOE 
GLYCERIN 
CETYL ALCOHOL 
STEARIC ACID 
ALKYL (C12-15) BENZOATE 
VITAMIN A PALMITATE 
.ALPHA.-TOCOPHEROL ACETATE 
ASIAN GINSENG 
CENTELLA ASIATICA 
ANGELICA SINENSIS ROOT 
RORIPPA NASTURTIUM-AQUATICUM 
RHUS GLABRA BARK 
CHAMOMILE 
DIMETHICONE 
DIETHANOLAMINE CETYL PHOSPHATE 
PHENOXYETHANOL 
BUTYLENE GLYCOL 
TROLAMINE 
CARBOMER 934 
TITANIUM DIOXIDE 
GLYCERETH-2 COCOATE 
IODOPROPYNYL BUTYLCARBAMATE 
Packaging
#Item CodePackage Description
1NDC:49825-117-021 JAR (JAR) in 1 BOX
1NDC:49825-117-0173 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2010
Labeler - Bioelements, Inc. (174813923)
Registrant - Bioelements, Inc. (174813923)
Establishment
NameAddressID/FEIOperations
Bioelements, Inc.174813923manufacture

Revised: 01/2012
 
Bioelements, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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