Sun Defense Cream

Generic Name: homosalate, octinoxate, octisalate and titanium dioxide
Dosage Form: cream

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.

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 Item Code (Source) NDC: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  
Packaging
# Item Code Package Description
1 NDC:63730-206-01 75 mL in 1 CARTON
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: 02/2010
 
Natura Bisse International



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