SUN Solar Defense Organic SPF30

Dosage form: cream
Ingredients: ZINC OXIDE 190mg in 1mL
Labeler: Allure Labs, Inc.
NDC Code: 62742-4038

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

Active Ingredients:

Zinc Oxide

Purpose:

Sunscreen

Uses:

  • An organic 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
  • Chemical free
Directions:

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

Indications:

Sensitive skin highly exposed to sun

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:

Water (Aqua), Cyclomethicone, Glycrin, Glyceryl Stearate (and) PEG 100 Stearate, Sorbitol, Imperata Cylindrica Root Extract, Polyacrylamide and C13-14 Isoparaffin and Laureth-7, Caprylyl Glycol and Phenoxyethanol and Hexylene Glycol, Lecithin, Ascorbyl Palmitate (Vitramin C), Xanthan Gum, Dipotassium Glyrhhizate, Olea Europea (Olive) Leaf Extract, Disodium EDTA.

Distributor:

Image International

Palm Beach, FL 33411 USA

www.imageskincare.com


Image of the product:



SUN SOLAR DEFENSE ORGANIC SPF30 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4038
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE190 mg  in 1 mL
Packaging
#Item CodePackage Description
1NDC:62742-4038-1118 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: 07/2010
 
Allure Labs, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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