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Celazome Botanical Mositurizer with SPF 15

Dosage form: lotion
Ingredients: Octinoxate 7.5g in 59mL, Octisalate 3g in 59mL, Oxybenzone 5g in 59mL
Labeler: Dermazone Solutions, LLC
NDC Code: 58466-023

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.

celazome®
Botanical Moisturizer
SPF 15 with Vitamin E

Directions

Apply evenly to all exposed areas of skin prior to sun exposure.

Warnings

For external use only. Avoid contact with eyes. If redness or irration appears discontinue use.

Active Ingredients

Octinoxate, Oxybenzone and Octisalate.

Manufactured by: Dermazone Solutions,
St. Petersburg, FL 33713 Made in U.S.A.

Visit our website: www.celazomeskin.com or call
1-800-253-5115.

PRINCIPAL DISPLAY PANEL - 60 ml Label

celazome®

Botanical Moisturizer
SPF 15 with Vitamin E

Clinical Skin Care
with Lyphazome® Technology

Net Wt. 2 fl. oz. (60ml)

CELAZOME BOTANICAL MOSITURIZER WITH SPF 15 
octinoxate, octisalate, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58466-023
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate7.5 g  in 59 mL
Octisalate (Octisalate) Octisalate3 g  in 59 mL
Oxybenzone (Oxybenzone) Oxybenzone5 g  in 59 mL
Packaging
#Item CodePackage Description
1NDC:58466-023-021 BOTTLE (BOTTLE) in 1 CARTON
159 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2004
Labeler - Dermazone Solutions, LLC (136116865)
Establishment
NameAddressID/FEIOperations
Dermazone Solutions, LLC136116865MANUFACTURE

Revised: 01/2010
Document Id: f40e76f0-bb3e-41ad-9587-b8afe6f2ac8f
Set id: 8b001970-1498-45af-bddf-f2a0dcd50764
Version: 1
Effective Time: 20100125
 
Dermazone Solutions, LLC

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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