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

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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

Bioelements

Sun Diffusing Protector SPF 15

177 mL / 6 Fl. Oz.

BIOELEMENTS  SUN DIFFUSING PROTECTOR octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide   cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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 No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 49825-114-02 1 BOTTLE In 1 BOX contains a BOTTLE (49825-114-01) 1 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 - Bioelemts Inc. (174813923)

Establishment
Name	Address	ID/FEI	Operations
Bioelements Inc.		174813923	manufacture

Revised: 06/2010Bioelements Inc.