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Sun Defense Cream

Generic name: homosalate, octinoxate, octisalate and titanium dioxide
Dosage form: cream

Medically reviewed by Drugs.com. Last updated on Jan 22, 2021.

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
Natura Bisse International

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