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Sun Defense Cream

Natura Bisse International




FULL PRESCRIBING INFORMATION

Sun Defense 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 ingredient

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

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 label Item Code (Source) NDC:63730-206
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HOMOSALATE Homosalate 2 mL
OCTINOXATE OCTINOXATE 6 mL
OCTISALATE OCTISALATE 4 mL
titanium dioxide 9 g

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 Marketing Start Date Marketing End Date
1 NDC:63730-206-01 75 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2004-01-01


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