CELAZOME MOISTURIZING SPF 30 ACTIVE- 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 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)

INGREDIENTS AND APPEARANCE

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

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 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: 58466-901-04	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(58466-901)