Label: CELAZOME MOISTURIZING SPF 30 ACTIVE- oxybenzone, octinoxate, octisalate, and homosalate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated November 16, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

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

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    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.

    Do not use on damaged or broken skin.

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

    Stop use and ask a doctor if rash occurs.

    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

  • SPL UNCLASSIFIED SECTION

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

  • 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)

    Principal Display Panel - 113 g Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CELAZOME   MOISTURIZING SPF 30 ACTIVE
    oxybenzone, octinoxate, octisalate, and homosalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58466-901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58466-901-041 in 1 CARTON10/01/2015
    1113 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35210/01/2015
    Labeler - Dermazone Solutions, Inc. (136116865)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deramzone Solutions, Inc.136116865MANUFACTURE(58466-901)
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