SUN TINTED SOLAR DEFENSE ORGANIC SPF 30 - zinc oxide 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.

----------

Drug Facts

Purpose:

A physical organic UVA/UVB broad spectrum daily moisturizer. Provides an even skin tone and healthy glow. Ultimate protection against the aging effects of the sun and other environmental pollutants. Enriched with essential vitamins and anti-oxidants that prevent free facical damage. Preserves skin hydration for the entire day.

Paraben Free

Provides Healthy even glow

Excellent for sensitive skin

Chemical free

Water resistant

Directions:

Apply liberally 15-30 minutes prior to sun exposure or as needed for a even skin tone. Reapply regulary or after prolonged swimming or activity.


Indications:

Sensitive skin, Sun exposure, uneven skin tone

Active Ingredients:

Zinc Oxide 17%

Inactive Ingredients:

Water (Aqua), Butylene Glycol, Glycerin, Caprylic/Capric Triglyceride, Glyceryl Stearate, PEG 100 Stearate, Sorbitan Stearate, Imperata Cylindrica Root Extract, Phenoxyethanol, Tocophery Linoleate, Ascorbyl Palmitate (Vitamin C), Lecithin, Tocopherol (Vitamin E), Xanthan Gum, Citric Acid, C13-14 Isoparaffin, PEG 8, Ethylhexylglycerin, Sodium Lactate, Micrococcus Lysate, Arabidopsis Extract, Plankton Extract, Teprenone, Phoenix dactylifera (date) Extract, Laureth-7, Disodium EDTA, Dipotassium Glycyrrizate, Caprylyl Glycol, Ascorbic Acid (Viamin C), Carbomer, Iron Oxides (CL 72124, Cl 7212 and Cl72123)

Distributor:

Image International

Palm Beach, FL 33411 USA



Image of the Product:

SUN Tinted Solar Defense Organic SPF 30


Image of the product


SUN TINTED SOLAR DEFENSE ORGANIC SPF 30 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4041
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE170 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4041-156.7 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: 9bdd2920-7c83-4fa7-83d9-c85a69e7e9e0
Set id: 05d3d7cb-00fa-4da3-ad06-f5ba318f9fe3
Version: 1
Effective Time: 20100702
 
Allure Labs, Inc.