RxNorm Names

Not yet provided

SUNZONE FAMILY SPF 30 BROAD SPECTRUM (octinoxate and avobenzone) lotion
[Empack Spraytech Inc]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4595c749-d9b8-4b39-ac9a-9d873ffee93f

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE: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 Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Active Ingredients

Octinoxate 2.0%

Avobenzone 0.75%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only

When using this product do not get into eyes. If contact occurs, rinse thoroughly with water

Stop Use and ask a doctor if irritation or rash occurs

Keep out of reach of children

If product is swallowed, get medical help or contact a Posion Control Center right away

Directions

Apply liberally and spread envenly 15 minutes before sun exposure
Reapply after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
Use in a well-ventilated area

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 broad spectrum SPF of 15 or higher and other sun

prtection measures including:

Limit time in the sun, especially from 10 am - 2 pm
Wear long-sleeve shirts, pants, hats and sunglasses
Children under 6 Months: ASK A DOCTOR

Inactive Ingredients

Acrylates Copolymer, Aloe Barbadensis Leaft Extract, Aminomethyl Propanol, Ammonium Acryloldimethyltaurate/VP Copolymer, C12-15 Alkyl Benzonate, Camellia Oleifera (Japanese Green Tea) Leaf Extract, Carthamus Tinctorius (Safflower) Oleosomes, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Phenyl Trimethicone, Tocopheryl acetate (Vitamin E), Water

Protect this product from excessive heat and direct sun

May stain some fabrics or surfaces

Call toll free 1-866-923-2665

Empack Spraytech Inc.

98 Walker drive, Brampton, Ontario

L6T 4H6

www.sunzone.ca

Made in Canada

Please Recycle

Can Label

SUNZONE FAMILY SPF 30 BROAD SPECTRUM
octinoxate and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50021-235
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (OCTINOXATE)	OCTINOXATE	4.70 g in 235 g
AVOBENZONE (AVOBENZONE)	AVOBENZONE	1.76 g in 235 g

Inactive Ingredients
Ingredient Name	Strength
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES
.ALPHA.-TOCOPHEROL ACETATE, DL-
PHENYL TRIMETHICONE
WATER
ALOE VERA LEAF
CAMELLIA OLEIFERA LEAF
GLYCERIN
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
AMINOMETHYLPROPANOL
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER

Packaging
#	Item Code	Package Description
1	NDC:50021-235-01	235 g in 1 TUBE
2	NDC:50021-235-02	235 g in 1 TUBE
3	NDC:50021-235-03	235 g in 1 TUBE
4	NDC:50021-235-04	235 g in 1 TUBE
5	NDC:50021-235-05	235 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/12/2012

Labeler - Empack Spraytech Inc (252047519)

Registrant - Empack Spraytech Inc (252047519)

Establishment
Name	Address	ID/FEI	Business Operations
Empack Spraytech Inc		252047519	manufacture(50021-235)

Revised: 11/2012

Document Id: 84b3de68-9b88-46d9-9234-a13925f2ec56

Set id: 4595c749-d9b8-4b39-ac9a-9d873ffee93f

Version: 2

Effective Time: 20121112

Empack Spraytech Inc

Daily Med

Current Medication Information

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