FDA Label for Celazome Moisturizing Spf 30 Active

View Indications, Usage & Precautions

Celazome Moisturizing Spf 30 Active Product Label

The following document was submitted to the FDA by the labeler of this product Dermazone Solutions, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts

Manufactured for Celazome® by:
Dermazone Solutions
St. Petersburg, FL 33713


Active Ingredients



Benzophenone-3 5.0%
Ethylhexyl Methoxycinnamate 7.5%
Ethylhexyl Salicylate 5.0%
Homosalate 5.0%


Purpose



Sunscreen


Uses



  • helps prevent sunburn

Skin Cancer/Skin Aging Alert



Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.


Otc - Do Not Use



Do not use on damaged or broken skin.


Otc - When Using



When using this product keep out of eyes. Rinse with water to remove.


Otc - Stop Use



Stop use and ask a doctor if rash occurs.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. - 2 p.m.
      • wear long-sleeve shirts, pants, hats, and sunglasses
      • children under 6 months: Ask a doctor

Inactive Ingredients



purifed water, sorbitol, dicaprylyl maleate, alcohol, potassium cetyl phosphate, lecithin, cetyl alcohol, dimethicone, tocopheryl acetate, aloe barbadensis leaf juice, carbomer, methylparaben, propylparaben, triethanolamine


Principal Display Panel - 113 G Bottle Carton



celazome®
clinical skin care

Moisturizing Sunscreen

Clinical Skin Care with
Lyphazome® Technology

SPF 30 ACTIVE
SPORT

WATER RESISTANT
(80 MINUTES)

4 OZ (113 g)


* Please review the disclaimer below.