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Bioelements

Bioelements Inc.
Bioelements Inc.

Sun Diffusing Protector SPF 15




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients                           Purpose

Octinoxate 7.5 %                           Sunscreen

Octisalate 5%                                Sunscreen

Oxybenzone 3%                            Sunscreen

Titanium Dioxide 0.01%                  Sunscreen

zinc Oxide 0.01%                           Sunscreen

Purpose

Uses

For skin highly sensitive to sunburn

Keep out of reach of children. If swallowed get medical help or contact poison control center right away.

Uses



Warnings

For external use only.

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


Directions

Apply liberally 30 minutes before sun exposure. Reapply as needed or after towel drying, swimming  or perspiring. Children under 6 months, ask a doctor.








Bioelements

Sun Diffusing Protector SPF 15

Broad Spectrum UVA/UVB protection

Moisturizing Formula




Bioelements

Bioelements

Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, Zinc Oxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49825-114
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 7.5 mL
OCTISALATE OCTISALATE 5 mL
OXYBENZONE OXYBENZONE 3 mL
titanium dioxide 0.01 mL
Zinc Oxide Zinc oxide 0.01 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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49825-114-01 177 in 1 BOTTLE
2 NDC:49825-114-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2009-01-01


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