You are here: Home > Over-the-counter (OTC) Drugs > B > Bioelementssun Diffusing Protector (Bioelements Inc.)

Name:Bioelementssun Diffusing Protector
Manufacturer:Bioelements Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Sun Diffusing Protector

BIOELEMENTS SUN DIFFUSING PROTECTOR - octinoxate, octisalate, oxybenzone, titanium dioxide and zinc oxide 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.

----------

Sun Diffusing Protector

Active Ingredient                           Purpose

Octinoxate 7.5%                           Sunscreen

Octisalate 5%                              Sunscreen

Oxybenzone 3%                           Sunscreen

Titanium Dioxide  0.01%               Sunscreen

Zinc Oxide 0.01%                        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), Sorbitol, C12-15 Alkyl Benzoate, DEA Cetyl Phosphate, Stearic Acid, Cetyl Alcohol, DImethicone, Carbomer, Lavendula Angustifolia (Lavender) Oil, Saliva Officinalis (Sage) Oil, Saliva Sclarea (Clary Sage) Oil, Citrus Aurantium (PetitgrainCordillera) Oil, Citrus Aurantium (Neroli) Oil, Lavendula Hybrida (Lavendin) Oil, Imidazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine

image of carton

Bioelements

Sun Diffusing Protector SPF 15

177 mL / 6 Fl. Oz.

image of front label


BIOELEMENTS  SUN DIFFUSING PROTECTOR
octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49825-114
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 5 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 3 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 0.01 mL  in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.01 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
SORBITOL  
ALKYL (C12-15) BENZOATE  
STEARIC ACID  
CETYL ALCOHOL  
DIMETHICONE  
LAVENDER OIL  
SAGE OIL  
CITRUS AURANTIUM FRUIT OIL  
CITRUS AURANTIUM FLOWER OIL  
IMIDUREA  
METHYLPARABEN  
PROPYLPARABEN  
TROLAMINE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49825-114-02 1 BOTTLE ( BOTTLE) in 1 BOX contains a BOTTLE (49825-114-01)
1 NDC:49825-114-01 177 mL in 1 BOTTLE This package is contained within the BOX (49825-114-02)

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
Bell Pharmaceuticals Inc 140653770 manufacture

Revised: 03/2011 Bioelements Inc.



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


Copyright © 2019 Drugsdb.eu by Dionisios Fentas || Terms of Use

Loading

OTC Marketed Drugs Alphabetically
A| B| C| D| E| F| G| H| I| J| K| L| M| N| O| P| Q| R| S| T| U| V| W| X| Y| Z| 0-9

Categories:
Prescription(RX) Drugs
Over-the-counter (OTC) Drugs
Homeopathic Drugs
Animal Drugs
Feedback