Sun Defense Cream

Generic Name: homosalate, octinoxate, octisalate and titanium dioxide

Dosage Form: cream

Natura Bisse Barcelona

Sun Defense SPF 50 Plus Ultra

Sun Defense Cream, Sunscreen for sensitive and sun reactive skin, water resistant

Net Wt. 2.5 Oz e 75 mL

Not tested on animals

Made in Spain by Natura Bisse Int. S.A., Pque. Techol. del Valles, Cerdanyola, 08290 Barcelona

Lot no.

Product Made in Spain and exported by Natura Bisse Int., S.A. Barcelona Espana

Imported and Distributed in Mexico for Natura Bisse Internacional S.A. de C.V., Herschel No. 50 Colonia Anzures, Delegacion Miguel Hidalgo, C.P. 11590 Mexico, D.F. RFC NBIO402132P0

Other Information: Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.  High sun protection product.

This product can be sold only by authorized Natura Bisse retailers.

Active ingredients: Homosalate (3%), Octinoxate (7.5%), Octisalate (5%), Titanium Dioxide (12.3%)

Other Ingredients: Water, Isononyl Isononanoate, Polyglyceryl-4 Isostearate, Glycerin, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Stearic Acid, Aluminum Hydroxide, Pisum Sativum (Pea) Extract, Aloe Barbadensis Leaf Extract, Helianthus Annuus (Sunflower) Seed Extract, Yeast (Faex) Extract, Sodium Chloride, Aluminum Stearate, Ascorbic Acid, Citric Acid, Disodium EDTA, Potassium Sorbate, Sodium Benzoate, Chlorphenesin, Imidazolidinyl Urea, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben, Fragrance, Linalool, Limonene, Citronellol, Iron Oxides, Alumina.

Uses: Helps prevent sunburn.  Higher SPF give more sunburn protection.

Warnings:

For external use only.  When using this product: Keep out of eyes.  Rinse with water to remove.  Stop use and ask doctor if rash or irritation develops and lasts.  Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.  If pregnant or breast-feeding, ask a health professional before use.

Directions: Apply evenly 30 minutes before sun exposure and reapply every 2-3 hours.  Children under 6 months of age: ask a doctor.

Sun Defense Cream  homosalate, octinoxate, methoxycinnamate, octisalate, titanium dioxide  cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 63730-206 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (Homosalate) Homosalate 2 mL  in 75 mL Octinoxate (Octinoxate) Octinoxate 6 mL  in 75 mL Octisalate (Octisalate) Octisalate 4 mL  in 75 mL Titanium Dioxide (Titanium Dioxide) Titanium Dioxide 9 g  in 75 mL

Inactive Ingredients Ingredient Name Strength Water   ISONONYL ISONONANOATE   POLYGLYCERYL-4 ISOSTEARATE   Glycerin   C12-15 ALKYL BENZOATE   Hexyl Laurate   Stearic Acid   Aluminum Hydroxide   Snow Pea   Aloe   Helianthus Annuus   Yeast   Sodium Chloride   Aluminum Stearate   Ascorbic Acid   Citric Acid Monohydrate   Edetate Disodium   Potassium Sorbate   Sodium Benzoate   Chlorphenesin   IMIDUREA   Phenoxyethanol   Methylparaben   Butylparaben   Ethylparaben   Propylparaben   Isobutylparaben   Linalool, DL-   Limonene, D-   Citronellol, DL-   ALUMINUM OXIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63730-206-01 75 mL In 1 CARTON None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2004

Labeler - Natura Bisse International (464431576)

Establishment
Name	Address	ID/FEI	Operations
Natura Bisse International		464431576	manufacture

Revised: 02/2010Natura Bisse International

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