1. Home
  2. Labeler Index
  3. Bioelements
  4. 49825-201
  5. Label Information: Spf 50 Face Sunscreen Bioelements

FDA Label for Spf 50 Face Sunscreen Bioelements

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Spf 50 Face Sunscreen Bioelements Product Label

The following document was submitted to the FDA by the labeler of this product Bioelements. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients                 Purpose

Avobenozone 3.0% ............. Sunscreen

Homosalate 10%   .............. Sunscreen

Octinoxate 7.0% ............... Sunscreen

Octisalate 5.0% ................ Sunscreen

Octocrylene 5.0% ............. Sunscreen

Oxybenzone 6.0% ............. Sunscreen


Otc - Purpose



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

Otc - Keep Out Of Reach Of Children



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


Indications & Usage



Stop use and ask a doctor if rash occurs


Warnings



Warnings

  • For external use only
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove.

Dosage & Administration



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 10a.m. - 2p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredient



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


Package Label.Principal Display Panel



Bioelements

SPF 50 FaceScreen

Broad Spectrum

SPF 50 Sunsceen

Daily anitioxidant moisturizer

68 mL/ 2.3 Fl. Oz.


* Please review the disclaimer below.