Celazome Cream
FDA Label NDC 58466-108

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermazone Llc for the product Celazome (NDC 58466-108). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Active Ingredients

Benzophenone-3 6.0%
Butyl Methoxydibenzoylmethane 3.0%
Ethylhexyl Methoxycinnamate 7.5%
Ethylhexyl Salicylate 5.0%
Homosalate 6.0%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

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

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

Principal Display Panel - 113 G Bottle Carton

celazome®
clinical skin care

DNArescue™
Moisturizing Sunscreen

Clinical Skin Care with
Lyphazome® Nanotechnology

SPF 29 ACTIVE
BROAD SPECTRUM

WATER RESISTANT
(80 MINUTES)

4 OZ (113 g)

Principal Display Panel (113 g Bottle Carton)

Principal Display Panel (113 g Bottle Carton)

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