CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE- oxybenzone, octinoxate, octisalate, and homosalate cream

celazome by

Drug Labeling and Warnings

celazome by is a Otc medication manufactured, distributed, or labeled by Dermazone Solutions, Inc., Deramzone Solutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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.

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

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

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

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)

INGREDIENTS AND APPEARANCE

CELAZOME   MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE
oxybenzone, octinoxate, octisalate, and homosalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58466-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58466-108-04	1 in 1 CARTON	10/01/2015
1		113 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	10/01/2015

Labeler - Dermazone Solutions, Inc. (136116865)

Establishment
Name	Address	ID/FEI	Business Operations
Deramzone Solutions, Inc.		136116865	MANUFACTURE(58466-108)