Facescreen SPF 50

Dosage form: liquid
Ingredients: AVOBENZONE 3.0mL in 100mL, HOMOSALATE 10mL in 100mL, OCTINOXATE 7.0mL in 100mL, OCTISALATE 5.0mL in 100mL, OCTOCRYLENE 5.0mL in 100mL, OXYBENZONE 6.0mL in 100mL
Labeler: Bioelements
NDC Code: 49825-122

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

Avobenzone 3.0%            Sunscreen

Homosalate 10%              Sunscreen

Octinoxate 7.0%               Sunscreen

Octisalate 5.0%                Sunscreen

Octocrylene 5.0%             Sunscreen

Oxybenzone 6.0%             Sunscreen

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

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

Stop use and ask a doctor if rash occurs

Warnings

For external use only

Do not use on broken or damaged skin

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

Directions

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Children under 6 months: Ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To Decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including

Limit time in the sun, especially from 10 a.m. - 2 p.m.

wear long-sleeve shirts, pants, hats, and sunglasses

Acrylates/C10-30 Alyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice Powder, Angelica Polymorpha Sinensis (Dong Quai) Root Extract, Ascorbyl Palmitate, Butylene Glycol, Centella Asiatica (Gotu Kola) Extract, Cetyl Dimethicone, Chamomile Recutita  (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nastartium Officinale (Watercress) Extract, Panax Ginseng (Ginseng) Root Extract, Phenoxyethanol, Phospholipids, Retinyl Palmitate, Rhus Glabra (Sumac) Extract, Steareth-2, Steareth-21, Tocopheryl Acetate, Triethanolamine, Water (Aqua,Eau)



Bioelements

SPF 50 FaceScreen

Broad Spectrum SPF 50 Sunscreen

68 mL/ 2.3 Fl. Oz.





FACESCREEN  SPF 50
avobenzone, homosalate, octinoxate, octisalate, octocrylene,oxybenzone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-122
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE3.0 mL  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE10 mL  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE7.0 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5.0 mL  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE5.0 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE6.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) 
ALOE VERA LEAF 
ANGELICA SINENSIS ROOT 
ASCORBYL PALMITATE 
BUTYLENE GLYCOL 
CENTELLA ASIATICA 
CHAMOMILE 
CHLORPHENESIN 
EDETATE DISODIUM 
GLYCERIN 
ASIAN GINSENG 
PHENOXYETHANOL 
VITAMIN A PALMITATE 
RHUS GLABRA BARK 
STEARETH-2 
STEARETH-21 
ALPHA-TOCOPHEROL ACETATE 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:49825-122-021 JAR (JAR) in 1 CARTON
1NDC:49825-122-0168 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/23/2012
Labeler - Bioelements (174813923)
Registrant - Bioelements (174813923)
Establishment
NameAddressID/FEIOperations
Cosmetic Enterprises017701475manufacture

Revised: 03/2012
 
Bioelements

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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