Celazome moisturizing spf 30 active cream

Spl unclassified section

Drug Facts

Active ingredients

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




  • 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, notskin cancer or early skin aging.

For external use only.

Otc - do not use section

Do not use on damaged or broken skin.

Otc - when using section

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

Otc - stop use section

Stop use and ask a doctor if rash occurs.

Otc - keep out of reach of children section

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


  • 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

Spl unclassified section

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

Ingredients and appearance - Product information

Celazome moisturizing spf 30 active cream- Oxybenzone, octinoxate, octisalate, and homosalate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 58466-901
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Oxybenzone ( UNII: 95OOS7VE0Y)( Oxybenzone - UNII: 95OOS7VE0Y ) 50 mgin 1 g
Octinoxate ( UNII: 4Y5P7MUD51)( Octinoxate - UNII: 4Y5P7MUD51 ) 75 mgin 1 g
Octisalate ( UNII: 4X49Y0596W)( Octisalate - UNII: 4X49Y0596W ) 50 mgin 1 g
Homosalate ( UNII: V06SV4M95S)( Homosalate - UNII: V06SV4M95S ) 50 mgin 1 g

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Dioctyl maleate ( UNII: OD88G8439L)
Alcohol ( UNII: 3K9958V90M)
Sorbitol ( UNII: 506T60A25R)
Diethanolamine cetyl phosphate ( UNII: 4UG0316V9S)
Aloe vera leaf ( UNII: ZY81Z83H0X)
.alpha.-tocopherol acetate ( UNII: 9E8X80D2L0)
Dimethicone ( UNII: 92RU3N3Y1O)
Cetyl alcohol ( UNII: 936JST6JCN)
Trolamine ( UNII: 9O3K93S3TK)
Propylparaben ( UNII: Z8IX2SC1OH)
Methylparaben ( UNII: A2I8C7HI9T)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date

Labeler - Dermazone Solutions, Inc.( 136116865)


Name ID/FEI Business Operations
Dermazone Solutions, Inc. 136116865 MANUFACTURE( 58466-901)

Principal display panel - 113 g bottle carton

celazome ®
clinical skin care

Moisturizing Sunscreen

Clinical Skin Care with
Lyphazome ®Technology



4 OZ (113 g)