SUN SOLAR DEFENSE HYDRATING  - zinc oxide, ethylhexyl methoxycinnamate, benzophenone, ethylhexyl salicylate cream 
Allure Labs, Inc.

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.

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Drug Facts

Active Ingredients:

Zinc Oxide 5%

Ethylhexyl Methoxycinnamate (Octinoxate) 7.5%

Benzophenone-3 3%

Ethylhexyl Salicylate (Octisalate) 5%

Uses:

A hydrating UVA/UVB broad spectrum daily moisturizer. Provides ultimate protection against the aging effects of the sun and other environmental exposures. Enriched with essential vitamins and anti-oxidants that prevent free radical damage and preserving skin hydration for the entire day.

Water-resistant

Paraben-free

Directions:

Apply to cleaned skin every morning for ultimate protection.

Indications: Dry, dehydrated, rosacea, sensitive.

Warnings:

For External use only

When using this product-

Keep out of eyes. If contact occurs rinse with water.

Discontinue use if irritation or redness occurs

Keep out of reach of children

Inactive Ingredients:

Deionized water (Aqua), C12-15 Alkyl Benzoate, Glyceryl Stearate (and) PEG-100 Stearate, Glycerin, Sodium Hyaluronate, Imperata Cylindrica Root Extract, Octyl Dodecyl Neopentanoate, Sorbitol, Caprylic/Capric Truglyceride, Camellia sinensis (Green Tea) Leaf Extract, Biosaccharide Gum-1, Algae Extract and Mugwort Extract, Caprylyl Glycol and Phnoxyethanol and Hexylene Glycol, Sodium PCA, Lecithin, Sorbitan Stearate, Symphytum Officinale Extract and Plantago Ovata Seed Extract, Yeast Extract, Aloe Barbadensis Leaf Extract, Spiraea Ulmaria Flower Extract (and) Centella Asiatica Extract, Magnesium Aluminum Silicate, Tocopheryl Acetate, Ascorbyl Palmitate, Disodium EDTA, Dipotassium Glycyrrizate, Amino Acids.

Image of the Product:

Image of the Product

Distributor:

Image International

Palm Beach, FL 33411 USA

www.imageskincare.com

SUN SOLAR DEFENSE HYDRATING  
zinc oxide, ethylhexyl methoxycinnamate, benzophenone, ethylhexyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4037
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE50 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4037-1118 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2010
Labeler - Allure Labs, Inc. (926831603)

Revised: 6/2010
Document Id: cea5b90c-cb67-4803-910e-625cba66ff37
Set id: ebfc03d8-d4dd-4d01-b0fe-f8f6c097c342
Version: 1
Effective Time: 20100630
 
Allure Labs, Inc.