SUN SOLAR DEFENSE OIL-FREE GEL SPF 15 - titanium dioxide, ethylhexyl methoxycinnamate, benzophenone-3 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:

Titanium Dioxide 1.6%

Ethylhexyl Methoxycinnamate (Octinoxate) 7.50%

Benzophenone-3: 3.00%


Purpose:

Sunscreen

Uses:

Directions:

Apply liberally 15-30 minute prior to sun exposure. Reapply after prolonged swimming or vigorous activity.

Indications:

Universal for all skin types.

Warnings:

For external use only.

When using this product

Keep out of reach of children

Inactive Ingredients:

Water (Aqua), Ethylhexyl Methoxycinnamate, Ascorbyl Palmitate, Cyclomethicone, Benzophenone-3, Glycerin, Glyceryl Stearate, Camellia Sinensis Leaf Extract (Green Tea), Tocopheryl Acetate, Phenoxyethanol, Lecithin, C13-14 Isoparaffin Citrus blend, Xanthan Gum, Disodium EDTA.

Distributor:

Image International
Palm Beach, FL 33411 USA

Image of the product:

Sun Solar Defense Oil-free Gel SPF 15

Image of the product

SUN SOLAR DEFENSE OIL-FREE GEL SPF 15 
titanium dioxide, ethylhexyl methoxycinnamate, benzophenone-3 cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4039
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE16 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
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4039-1118 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: 7/2010
Document Id: 1f4eca23-2fe7-4ba0-8e19-7923e510efa8
Set id: 197a68f8-ba73-432f-b215-f715a494d06d
Version: 1
Effective Time: 20100701
 
Allure Labs, Inc.