Celazome Mositurizing Sunscreen with SPF 29

Dosage form: lotion
Ingredients: Oxybenzone 5.9g in 118mL, Octinoxate 8.9g in 118mL, Octisalate 5.9g in 118mL, Homosalate 5.9g in 118mL, Avobenzone 2.4g in 118mL
Labeler: Dermazone Solutions, LLC
NDC Code: 58466-104

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®
Moisturizing Sunscreen
MAX SPF 29

Drug Facts

Active ingredientsPurpose
Avobenzone (Parsol 1789) 2.0%
Homosalate 5.0%, Octinoxate 7.5%,
Octisalate 5.0%,
Oxybenzone 5.0%Sunscreen

Uses
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.

Warnings
  • External use only.
  • Keep out of reach of children.

When using this product

  • Keep out of eyes. Rinse with warm water to remove.

Stop use and ask a doctor if

  • Rash or irritation develops and lasts.

Directions
  • Apply evenly before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.

Inactive ingredients

Deionized Water, Dicaprylyl Maleate, Alcohol, Sorbitol, DEA-Cetyl Phosphate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Lecithin, Dimethicone, Cetyl Alcohol, Carbomer, Triethanolamine, Propylparaben, Methylparaben.

Manufactured by:
Dermazone Solutions

St. Petersburg, FL 33713
www.celazomeskin.com

Made in USA

Customer Service 1-800-253-5115

PRINCIPAL DISPLAY PANEL - 118 ml carton

celazome®

Moisturizing Sunscreen
with Lyphazome® Technology

MAX SPF 29

UVAI, UVAII, UVB Protection

Rubproof

Sweatproof

With Parsol 1789®
for extra UV Protection

4 FL. OZ. (118 ml)

CELAZOME MOSITURIZING SUNSCREEN WITH SPF 29 
oxybenzone, octinoxate, octisalate, homosalate, and avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58466-104
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxybenzone (Oxybenzone) Oxybenzone5.9 g  in 118 mL
Octinoxate (Octinoxate) Octinoxate8.9 g  in 118 mL
Octisalate (Octisalate) Octisalate5.9 g  in 118 mL
Homosalate (Homosalate) Homosalate5.9 g  in 118 mL
Avobenzone (Avobenzone) Avobenzone2.4 g  in 118 mL
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58466-104-041 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
 
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 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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